Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 2:10 PM
Study NCT ID:
NCT03718832
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fresh Food Farmacy: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjdoyle@mit.edu', 'phone': '6174523761', 'title': 'Joseph doyle', 'organization': 'MIT Sloan School of Management'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Pandemic timeperiod: Estimates were similar, though modestly powered, using only pre-pandemic data.\n2. Effects may differ at other health systems / patients who are not well connect to a system.\n3. Wait list design: control group members may take additional actions due to awareness of the program.\n4. Lack of detailed recall measures.\n5. It may take longer than 6-12 months for the intervention to change these outcomes.'}}, 'adverseEventsModule': {'timeFrame': '18 months.', 'description': 'Study was deemed minimal risk by the Institutional Review Board, and study-related adverse events and unanticipated problems were tracked.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 0, 'seriousNumAtRisk': 249, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 0, 'seriousNumAtRisk': 251, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.781177', 'spread': '1.643995', 'groupId': 'OG000'}, {'value': '8.814526', 'spread': '1.978937', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8638688', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0333487', 'ciLowerLimit': '-0.415628', 'ciUpperLimit': '0.3489306', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1943638', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9714571', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0066385', 'ciLowerLimit': '-0.371329', 'ciUpperLimit': '0.358052', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1853917', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months after trial enrollment', 'description': "Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood.\n\nUnits are percentages; for differences between HbA1c values, units are percentage points.\n\nAn HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.", 'unitOfMeasure': '% of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the 465-person analysis sample who completed an HbA1c blood test between 5 and 10 months after program enrollment.'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.735975', 'spread': '1.748229', 'groupId': 'OG000'}, {'value': '8.595031', 'spread': '2.035983', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5039565', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1409446', 'ciLowerLimit': '-0.2735162', 'ciUpperLimit': '0.5554053', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2106711', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5684854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1213915', 'ciLowerLimit': '-0.2970052', 'ciUpperLimit': '0.5397882', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2126328', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months after trial enrollment', 'description': 'Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months.\n\nAn HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%.\n\nIn the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.', 'unitOfMeasure': '% of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185.0236', 'spread': '76.36467', 'groupId': 'OG000'}, {'value': '198.292', 'spread': '99.97935', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185.4696', 'spread': '68.86821', 'groupId': 'OG000'}, {'value': '172.3441', 'spread': '68.18301', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2247426', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.26835', 'ciLowerLimit': '-34.73804', 'ciUpperLimit': '8.201347', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.90353', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2794015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.20164', 'ciLowerLimit': '-34.37119', 'ciUpperLimit': '9.9679', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.25555', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1708328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.12548', 'ciLowerLimit': '-5.703702', 'ciUpperLimit': '31.95466', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.550462', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2801138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.47577', 'ciLowerLimit': '-9.422762', 'ciUpperLimit': '32.3743', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.59479', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast).\n\nUnits are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who completed blood tests between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Weight (lb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '230.8205', 'spread': '60.13527', 'groupId': 'OG000'}, {'value': '238.9561', 'spread': '66.3286', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227.9171', 'spread': '58.1217', 'groupId': 'OG000'}, {'value': '237.5989', 'spread': '63.47953', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1991028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.135585', 'ciLowerLimit': '-20.57023', 'ciUpperLimit': '4.299061', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.325031', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0480884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.493798', 'ciLowerLimit': '0.0295297', 'ciUpperLimit': '6.958066', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.761916', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1276817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.681804', 'ciLowerLimit': '-22.15188', 'ciUpperLimit': '2.788269', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.34136', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3318554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.658257', 'ciLowerLimit': '-1.698022', 'ciUpperLimit': '5.014535', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.706497', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Weight in pounds. In the context of this study, higher values are considered a worse outcome.\n\nSI conversion factor: To convert pounds to kilograms, multiply by 0.4536.', 'unitOfMeasure': 'pounds (lb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who had their weight recorded between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.77117', 'spread': '8.615884', 'groupId': 'OG000'}, {'value': '37.6461', 'spread': '10.06821', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.20175', 'spread': '8.299285', 'groupId': 'OG000'}, {'value': '37.65195', 'spread': '9.895644', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3502313', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8749266', 'ciLowerLimit': '-2.714084', 'ciUpperLimit': '0.9642311', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9355095', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0390797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5608222', 'ciLowerLimit': '0.0282451', 'ciUpperLimit': '1.093399', 'pValueComment': 'Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2708671', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1281032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.450197', 'ciLowerLimit': '-3.320109', 'ciUpperLimit': '0.419716', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9508997', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3044732', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2794625', 'ciLowerLimit': '-0.2549974', 'ciUpperLimit': '0.8139224', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2717457', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': "Body Mass Index (BMI) in kg/m\\^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants whose weight was recorded between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '170.3087', 'spread': '55.49542', 'groupId': 'OG000'}, {'value': '160.5404', 'spread': '48.39021', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164.8345', 'spread': '50.04346', 'groupId': 'OG000'}, {'value': '165.3806', 'spread': '56.96481', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1007463', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.768353', 'ciLowerLimit': '-1.907847', 'ciUpperLimit': '21.44455', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.933945', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3859868', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.472004', 'ciLowerLimit': '-5.66534', 'ciUpperLimit': '14.60935', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.150772', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9324908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5461143', 'ciLowerLimit': '-13.22545', 'ciUpperLimit': '12.13323', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.440905', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6328075', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.752831', 'ciLowerLimit': '-14.08487', 'ciUpperLimit': '8.579205', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.754947', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome.\n\nSI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.54835', 'spread': '44.67019', 'groupId': 'OG000'}, {'value': '85.19621', 'spread': '36.72769', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.36268', 'spread': '36.73616', 'groupId': 'OG000'}, {'value': '84.72519', 'spread': '36.62367', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0743062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.352141', 'ciLowerLimit': '-0.8250086', 'ciUpperLimit': '17.52929', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.663846', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1270654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.971188', 'ciLowerLimit': '-1.709219', 'ciUpperLimit': '13.65159', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.902349', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.553277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.637485', 'ciLowerLimit': '-6.110146', 'ciUpperLimit': '11.38512', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.443227', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.519562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53149', 'ciLowerLimit': '-5.198658', 'ciUpperLimit': '10.26164', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.925307', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome.\n\nSI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.27718', 'spread': '12.98269', 'groupId': 'OG000'}, {'value': '41.8323', 'spread': '12.08006', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.34722', 'spread': '12.73743', 'groupId': 'OG000'}, {'value': '43.73333', 'spread': '17.07761', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6976216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.555117', 'ciLowerLimit': '-3.363839', 'ciUpperLimit': '2.253605', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.427417', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6329035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4977997', 'ciLowerLimit': '-2.546815', 'ciUpperLimit': '1.551216', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.041102', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.445181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.386111', 'ciLowerLimit': '-4.954999', 'ciUpperLimit': '2.182777', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.812939', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5542241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.101914', 'ciLowerLimit': '-4.765783', 'ciUpperLimit': '2.561956', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.860687', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome.\n\nSI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223.5705', 'spread': '155.5674', 'groupId': 'OG000'}, {'value': '201.0123', 'spread': '157.1144', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212.7762', 'spread': '153.4214', 'groupId': 'OG000'}, {'value': '224.1288', 'spread': '268.9378', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2045348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.55812', 'ciLowerLimit': '-12.35316', 'ciUpperLimit': '57.4694', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.74244', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3675252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.49781', 'ciLowerLimit': '-15.93658', 'ciUpperLimit': '42.9322', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.95579', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6709307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.35256', 'ciLowerLimit': '-63.8992', 'ciUpperLimit': '41.19407', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.69115', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6766844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.912496', 'ciLowerLimit': '-50.95358', 'ciUpperLimit': '33.12859', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.34891', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes.\n\nSI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.3118', 'spread': '19.06545', 'groupId': 'OG000'}, {'value': '130.1823', 'spread': '20.29064', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.0235', 'spread': '17.24071', 'groupId': 'OG000'}, {'value': '129.7956', 'spread': '18.45165', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.356123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.870464', 'ciLowerLimit': '-5.851219', 'ciUpperLimit': '2.110291', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.024497', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6566494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8636408', 'ciLowerLimit': '-4.681041', 'ciUpperLimit': '2.95376', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.941141', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0484944', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.772051', 'ciLowerLimit': '-7.519021', 'ciUpperLimit': '-0.0250809', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.905125', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.234947', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.167034', 'ciLowerLimit': '-5.749627', 'ciUpperLimit': '1.415558', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.821244', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.2043', 'spread': '10.71504', 'groupId': 'OG000'}, {'value': '74.76041', 'spread': '10.40413', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.48235', 'spread': '9.271847', 'groupId': 'OG000'}, {'value': '73.98343', 'spread': '10.46395', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6091477', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5561156', 'ciLowerLimit': '-2.693002', 'ciUpperLimit': '1.58077', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.086759', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.713942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3787962', 'ciLowerLimit': '-2.409379', 'ciUpperLimit': '1.651786', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.032547', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6362064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4989275', 'ciLowerLimit': '-1.573807', 'ciUpperLimit': '2.571662', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.053869', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2748884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.146286', 'ciLowerLimit': '-0.9154561', 'ciUpperLimit': '3.208027', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.048105', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Times Eating Fruit in the Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.564417', 'spread': '3.344494', 'groupId': 'OG000'}, {'value': '5.241177', 'spread': '3.397799', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.097222', 'spread': '2.377986', 'groupId': 'OG000'}, {'value': '5.79562', 'spread': '3.343428', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3823224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3232407', 'ciLowerLimit': '-0.4036366', 'ciUpperLimit': '1.050118', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3695066', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4829339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2619965', 'ciLowerLimit': '-0.4718566', 'ciUpperLimit': '0.9958495', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3729922', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.045506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6983982', 'ciLowerLimit': '-1.382737', 'ciUpperLimit': '-0.0140597', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3476441', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0625551', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6239824', 'ciLowerLimit': '-1.280906', 'ciUpperLimit': '0.0329412', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3336405', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.', 'unitOfMeasure': '# times', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Times Eating Dark Green Vegetables in the Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.288343', 'spread': '20.69643', 'groupId': 'OG000'}, {'value': '4.011765', 'spread': '2.9007', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.202797', 'spread': '2.378186', 'groupId': 'OG000'}, {'value': '5.782609', 'spread': '8.36899', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1650343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.276579', 'ciLowerLimit': '-0.9420086', 'ciUpperLimit': '5.495166', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.636162', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1442126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.989458', 'ciLowerLimit': '-0.6843682', 'ciUpperLimit': '4.663284', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.359013', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0335498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.579811', 'ciLowerLimit': '-3.03574', 'ciUpperLimit': '-0.1238828', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.739612', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0398937', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.764632', 'ciLowerLimit': '-3.447175', 'ciUpperLimit': '-0.0820899', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8545352', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.', 'unitOfMeasure': '# times', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Times Drinking Sweetened Beverages in the Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.777778', 'spread': '3.449728', 'groupId': 'OG000'}, {'value': '3.407186', 'spread': '4.495186', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.377622', 'spread': '3.116978', 'groupId': 'OG000'}, {'value': '2.550725', 'spread': '3.60266', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1544491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6294078', 'ciLowerLimit': '-1.496923', 'ciUpperLimit': '0.238107', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4409795', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1793486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6081765', 'ciLowerLimit': '-1.497352', 'ciUpperLimit': '0.2809987', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.451915', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6674618', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1731023', 'ciLowerLimit': '-0.9653829', 'ciUpperLimit': '0.6191784', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4024787', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5992113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2208031', 'ciLowerLimit': '-1.047063', 'ciUpperLimit': '0.6054567', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4196435', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.', 'unitOfMeasure': '# times', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Times Eating Out in the Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.948285', 'groupId': 'OG000'}, {'value': '4.017544', 'spread': '3.78771', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.402778', 'spread': '3.956617', 'groupId': 'OG000'}, {'value': '4.413043', 'spread': '3.927682', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2549037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4824561', 'ciLowerLimit': '-0.349686', 'ciUpperLimit': '1.314598', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. 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Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4695747', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9443607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0340184', 'ciLowerLimit': '-0.9928399', 'ciUpperLimit': '0.9248032', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4869778', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant.', 'unitOfMeasure': '# times', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Participants Answering "Yes" for Diet Improvement Compared to One Year Ago', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0000252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.160997', 'ciLowerLimit': '0.0868814', 'ciUpperLimit': '0.2351126', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0376773', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0000204', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1691707', 'ciLowerLimit': '0.0922183', 'ciUpperLimit': '0.2461232', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0391132', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9130816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0028595', 'ciLowerLimit': '-0.0486635', 'ciUpperLimit': '0.0543825', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0261733', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5400053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0166325', 'ciLowerLimit': '-0.0367394', 'ciUpperLimit': '0.0700045', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0271062', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Survey question: "Do you believe your diet has improved compared to one year ago?".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Mean Proportion of Diabetes Knowledge Questions Answered Correctly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8267857', 'spread': '0.1489169', 'groupId': 'OG000'}, {'value': '0.7756302', 'spread': '0.1472909', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8271728', 'spread': '0.1416987', 'groupId': 'OG000'}, {'value': '0.8133472', 'spread': '0.1444886', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0018721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0511555', 'ciLowerLimit': '0.0190582', 'ciUpperLimit': '0.0832528', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016316', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0106231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0433081', 'ciLowerLimit': '0.0101555', 'ciUpperLimit': '0.0764607', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0168497', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4197898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0138256', 'ciLowerLimit': '-0.0198584', 'ciUpperLimit': '0.0475096', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0171112', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2961479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0179852', 'ciLowerLimit': '-0.0158442', 'ciUpperLimit': '0.0518147', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0171811', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': "The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly.", 'unitOfMeasure': 'proportion of questions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Engagement Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4018523', 'spread': '0.8282961', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000623', 'spread': '0.8280342', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0000743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4018522', 'ciLowerLimit': '0.2048311', 'ciUpperLimit': '0.5988733', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1001575', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3643095', 'ciLowerLimit': '0.16227', 'ciUpperLimit': '0.566349', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1026922', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9954683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0006229', 'ciLowerLimit': '-0.2150785', 'ciUpperLimit': '0.2163243', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1095781', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8852268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0161147', 'ciLowerLimit': '-0.2357129', 'ciUpperLimit': '0.2034834', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1115322', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Survey-based index score for patient-reported positive engagement outcomes.\n\nScores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Outpatient Visits Claimed by Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '5.765217', 'spread': '4.884394', 'groupId': 'OG000'}, {'value': '4.86383', 'spread': '4.628804', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '10.1', 'spread': '8.088674', 'groupId': 'OG000'}, {'value': '10.07234', 'spread': '8.314793', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0417413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9013876', 'ciLowerLimit': '0.0338441', 'ciUpperLimit': '1.768931', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4414753', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0222222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8939751', 'ciLowerLimit': '0.1282798', 'ciUpperLimit': '1.65967', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3896126', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9710103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0276596', 'ciLowerLimit': '-1.467185', 'ciUpperLimit': '1.522504', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7606961', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9539117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0377244', 'ciLowerLimit': '-1.244338', 'ciUpperLimit': '1.319787', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6523585', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.', 'unitOfMeasure': 'Number of claims', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Inpatient and Emergency Department Visits Claimed by Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '0.6869565', 'spread': '1.363051', 'groupId': 'OG000'}, {'value': '0.7914894', 'spread': '1.680434', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '1.221739', 'spread': '2.116365', 'groupId': 'OG000'}, {'value': '1.497872', 'spread': '3.350436', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4612408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1045328', 'ciLowerLimit': '-0.3830955', 'ciUpperLimit': '0.1740299', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1417549', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6401864', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0552724', 'ciLowerLimit': '-0.2874987', 'ciUpperLimit': '0.176954', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1181649', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2874913', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2761332', 'ciLowerLimit': '-0.7857084', 'ciUpperLimit': '0.2334419', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2593125', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4568601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.155843', 'ciLowerLimit': '-0.56713', 'ciUpperLimit': '0.2554439', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2092772', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.', 'unitOfMeasure': 'Number of claims', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Filing Outpatient Insurance Claims With Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0442418', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0539315', 'ciLowerLimit': '0.0013953', 'ciUpperLimit': '0.1064678', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0267347', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0454857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0546574', 'ciLowerLimit': '0.0011025', 'ciUpperLimit': '0.1082124', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0272506', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.683764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0076781', 'ciLowerLimit': '-0.0293401', 'ciUpperLimit': '0.0446963', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0188378', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7708852', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0053342', 'ciLowerLimit': '-0.0306419', 'ciUpperLimit': '0.0413103', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0183059', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2245167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.053099', 'ciLowerLimit': '-0.1388926', 'ciUpperLimit': '0.0326946', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0436586', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0551913', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0815933', 'ciLowerLimit': '-0.1650069', 'ciUpperLimit': '0.0018204', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0424438', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2721373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0506938', 'ciLowerLimit': '-0.1413002', 'ciUpperLimit': '0.0399126', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0461078', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0640071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.079563', 'ciLowerLimit': '-0.1637776', 'ciUpperLimit': '0.0046516', 'pValueComment': 'Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0428514', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Inpatient and Emergency Department Payments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2175.39', 'spread': '6176.236', 'groupId': 'OG000'}, {'value': '2161.593', 'spread': '5284.944', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3284.667', 'spread': '7850.193', 'groupId': 'OG000'}, {'value': '4545.119', 'spread': '9951.439', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9864081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.79692', 'ciLowerLimit': '-1581.244', 'ciUpperLimit': '1608.838', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '808.862', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8929133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '119.3302', 'ciLowerLimit': '-1627.128', 'ciUpperLimit': '1865.789', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '885.2058', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.343724', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1260.452', 'ciLowerLimit': '-3880.298', 'ciUpperLimit': '1359.393', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1327.743', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3709654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1206.216', 'ciLowerLimit': '-3860.887', 'ciUpperLimit': '1448.455', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1344.574', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.', 'unitOfMeasure': 'USD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Outpatient Payments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3313.627', 'spread': '6553.01', 'groupId': 'OG000'}, {'value': '2023.022', 'spread': '3492.728', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5327.305', 'spread': '7561.854', 'groupId': 'OG000'}, {'value': '4117.954', 'spread': '5205.939', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0795087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1290.605', 'ciLowerLimit': '-153.3215', 'ciUpperLimit': '2734.532', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '732.2306', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1689786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1207.762', 'ciLowerLimit': '-517.7854', 'ciUpperLimit': '2933.309', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '874.6068', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2080145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1209.35', 'ciLowerLimit': '-679.1596', 'ciUpperLimit': '3097.86', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '957.1006', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2445904', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1258.587', 'ciLowerLimit': '-869.3893', 'ciUpperLimit': '3386.563', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1077.807', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.', 'unitOfMeasure': 'USD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Visits to a Dietician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '2.656522', 'spread': '1.745694', 'groupId': 'OG000'}, {'value': '0.6212766', 'spread': '1.263041', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '4.53913', 'spread': '3.029079', 'groupId': 'OG000'}, {'value': '2.919149', 'spread': '2.701269', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.035245', 'ciLowerLimit': '1.757075', 'ciUpperLimit': '2.313415', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1415551', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0087', 'ciLowerLimit': '1.734473', 'ciUpperLimit': '2.282927', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1395364', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.619982', 'ciLowerLimit': '1.096575', 'ciUpperLimit': '2.143388', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2663507', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.559642', 'ciLowerLimit': '1.032797', 'ciUpperLimit': '2.086488', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2680774', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.', 'unitOfMeasure': 'number of visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Diabetes Self-Management Trainings Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '2.243478', 'spread': '1.439258', 'groupId': 'OG000'}, {'value': '0.3617021', 'spread': '0.7168763', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '3.791304', 'spread': '2.498893', 'groupId': 'OG000'}, {'value': '2.140425', 'spread': '1.888297', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.881776', 'ciLowerLimit': '1.673875', 'ciUpperLimit': '2.089677', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1057965', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.868221', 'ciLowerLimit': '1.664499', 'ciUpperLimit': '2.071943', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1036609', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.650879', 'ciLowerLimit': '1.246611', 'ciUpperLimit': '2.055147', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2057239', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.636306', 'ciLowerLimit': '1.232994', 'ciUpperLimit': '2.039618', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2052192', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.', 'unitOfMeasure': 'number of trainings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Visits to an Endocrinologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '0.5913044', 'spread': '0.8605437', 'groupId': 'OG000'}, {'value': '0.4808511', 'spread': '0.7970668', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '1.095652', 'spread': '1.468588', 'groupId': 'OG000'}, {'value': '0.8893617', 'spread': '1.302731', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1519153', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1104533', 'ciLowerLimit': '-0.040785', 'ciUpperLimit': '0.2616915', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0769621', 'groupDescription': 'Unadjusted mean difference, 6 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3641254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0594575', 'ciLowerLimit': '-0.0691675', 'ciUpperLimit': '0.1880824', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0654489', 'groupDescription': 'Adjusted mean difference for full controls, 6 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1100186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2062905', 'ciLowerLimit': '-0.0468859', 'ciUpperLimit': '0.4594669', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1288363', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2531303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1162375', 'ciLowerLimit': '-0.0834025', 'ciUpperLimit': '0.3158775', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1015839', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.', 'unitOfMeasure': 'number of appointments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Weight Loss and Weight Management Appointments Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'OG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'classes': [{'title': '6 months after trial enrollment', 'categories': [{'measurements': [{'value': '0.0521739', 'spread': '0.3457409', 'groupId': 'OG000'}, {'value': '0.1106383', 'spread': '0.5193825', 'groupId': 'OG001'}]}]}, {'title': '12 months after trial enrollment', 'categories': [{'measurements': [{'value': '0.0521739', 'spread': '0.3457409', 'groupId': 'OG000'}, {'value': '0.2212766', 'spread': '0.9707113', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.152918', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0584644', 'ciLowerLimit': '-0.1387132', 'ciUpperLimit': '0.0217844', 'pValueComment': 'Unadjusted mean difference; threshold for statistical significance: 0.05. 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Heteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0673022', 'groupDescription': 'Unadjusted mean difference, 12 months after trial enrollment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0032534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1701425', 'ciLowerLimit': '-0.2831584', 'ciUpperLimit': '-0.0571266', 'pValueComment': 'Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.\n\nHeteroskedasticity-robust standard errors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0575065', 'groupDescription': 'Adjusted mean difference for full controls, 12 months after trial enrollment.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records.', 'unitOfMeasure': 'number of appointments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthy Behaviors Observed in Electronic Health Record', 'timeFrame': '6 months and 12 months', 'description': 'Healthy behaviors observed in electronic health record, including preventive care and appointments kept', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthy Behaviors Observed in Paid Claims HEDIS Measures', 'timeFrame': '6 months and 12 months', 'description': 'Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'HbA1c available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Weight for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Weight in pounds as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'BMI for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'BMI in kg/m\\^2 in pounds as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cholesterol for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Cholesterol as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Pressure for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Blood pressure as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Triglycerides for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Triglycerides as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fasting Glucose for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Fasting glucose as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inpatient Utilization for Household Members in EHR Records', 'timeFrame': '6 months and 12 months', 'description': 'Inpatient utilization for household members as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Outpatient Utilization for Household Members in EHR Records', 'timeFrame': '6 months and 12 months', 'description': 'Outpatient utilization for household members as available in EHR records', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inpatient Utilization for Household Members in Paid Claims', 'timeFrame': '6 months and 12 months', 'description': 'Inpatient utilization for household members as available in paid claims', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Outpatient Utilization for Household Members in Paid Claims', 'timeFrame': '6 months and 12 months', 'description': 'Outpatient utilization for household members as available in paid claims', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heterogeneity: HbA1c by Baseline Level of HbA1c', 'timeFrame': '6 months and 12 months', 'description': 'Separate results by tercile of baseline HbA1c', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heterogeneity: HbA1c by Site', 'timeFrame': '6 months and 12 months', 'description': 'Heterogeneity analysis by site of the clinic', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heterogeneity: HbA1c by Causal Tree', 'timeFrame': '6 months and 12 months', 'description': 'Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'FG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'periods': [{'title': 'Analysis Sample', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Legal hold on data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant from treated household', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '6-month HbA1c Sample', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).\n\nFresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.'}, {'id': 'BG001', 'title': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic (any race)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic and other race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior-year healthcare use', 'classes': [{'title': 'Any inpatient admission', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Any emergency department visit', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinic location', 'classes': [{'title': 'Rural', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Urban', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-24', 'size': 395385, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-04T10:15', 'hasProtocol': True}, {'date': '2019-04-10', 'size': 210178, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-23T10:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2018-10-17', 'resultsFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Healthy Behaviors Observed in Electronic Health Record', 'timeFrame': '6 months and 12 months', 'description': 'Healthy behaviors observed in electronic health record, including preventive care and appointments kept'}, {'measure': 'Healthy Behaviors Observed in Paid Claims HEDIS Measures', 'timeFrame': '6 months and 12 months', 'description': 'Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.'}, {'measure': 'HbA1c for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'HbA1c available in EHR records'}, {'measure': 'Weight for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Weight in pounds as available in EHR records'}, {'measure': 'BMI for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'BMI in kg/m\\^2 in pounds as available in EHR records'}, {'measure': 'Cholesterol for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Cholesterol as available in EHR records'}, {'measure': 'Blood Pressure for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Blood pressure as available in EHR records'}, {'measure': 'Triglycerides for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Triglycerides as available in EHR records'}, {'measure': 'Fasting Glucose for Household Members', 'timeFrame': '6 months and 12 months', 'description': 'Fasting glucose as available in EHR records'}, {'measure': 'Inpatient Utilization for Household Members in EHR Records', 'timeFrame': '6 months and 12 months', 'description': 'Inpatient utilization for household members as available in EHR records'}, {'measure': 'Outpatient Utilization for Household Members in EHR Records', 'timeFrame': '6 months and 12 months', 'description': 'Outpatient utilization for household members as available in EHR records'}, {'measure': 'Inpatient Utilization for Household Members in Paid Claims', 'timeFrame': '6 months and 12 months', 'description': 'Inpatient utilization for household members as available in paid claims'}, {'measure': 'Outpatient Utilization for Household Members in Paid Claims', 'timeFrame': '6 months and 12 months', 'description': 'Outpatient utilization for household members as available in paid claims'}, {'measure': 'Heterogeneity: HbA1c by Baseline Level of HbA1c', 'timeFrame': '6 months and 12 months', 'description': 'Separate results by tercile of baseline HbA1c'}, {'measure': 'Heterogeneity: HbA1c by Site', 'timeFrame': '6 months and 12 months', 'description': 'Heterogeneity analysis by site of the clinic'}, {'measure': 'Heterogeneity: HbA1c by Causal Tree', 'timeFrame': '6 months and 12 months', 'description': 'Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.'}], 'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '6 months after trial enrollment', 'description': "Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood.\n\nUnits are percentages; for differences between HbA1c values, units are percentage points.\n\nAn HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome."}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '12 months after trial enrollment', 'description': 'Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months.\n\nAn HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%.\n\nIn the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.'}, {'measure': 'Fasting Glucose', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast).\n\nUnits are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study.'}, {'measure': 'Weight (lb)', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Weight in pounds. In the context of this study, higher values are considered a worse outcome.\n\nSI conversion factor: To convert pounds to kilograms, multiply by 0.4536.'}, {'measure': 'Body Mass Index', 'timeFrame': '6 and 12 months after trial enrollment', 'description': "Body Mass Index (BMI) in kg/m\\^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome."}, {'measure': 'Total Cholesterol', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome.\n\nSI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.'}, {'measure': 'LDL Cholesterol', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome.\n\nSI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.'}, {'measure': 'HDL Cholesterol', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome.\n\nSI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259.'}, {'measure': 'Triglycerides', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes.\n\nSI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes.'}, {'measure': 'Times Eating Fruit in the Past 7 Days', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.'}, {'measure': 'Times Eating Dark Green Vegetables in the Past 7 Days', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.'}, {'measure': 'Times Drinking Sweetened Beverages in the Past 7 Days', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.'}, {'measure': 'Times Eating Out in the Past 7 Days', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant.'}, {'measure': 'Participants Answering "Yes" for Diet Improvement Compared to One Year Ago', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Patient-reported measure of diet improvement: Survey question: "Do you believe your diet has improved compared to one year ago?".'}, {'measure': 'Mean Proportion of Diabetes Knowledge Questions Answered Correctly', 'timeFrame': '6 and 12 months after trial enrollment', 'description': "The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly."}, {'measure': 'Engagement Index Score', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Survey-based index score for patient-reported positive engagement outcomes.\n\nScores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions.'}, {'measure': 'Number of Outpatient Visits Claimed by Insurance', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.'}, {'measure': 'Number of Inpatient and Emergency Department Visits Claimed by Insurance', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.'}, {'measure': 'Proportion of Participants Filing Outpatient Insurance Claims With Insurance', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.'}, {'measure': 'Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.'}, {'measure': 'Inpatient and Emergency Department Payments', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.'}, {'measure': 'Outpatient Payments', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.'}, {'measure': 'Number of Visits to a Dietician', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.'}, {'measure': 'Number of Diabetes Self-Management Trainings Completed', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.'}, {'measure': 'Number of Visits to an Endocrinologist', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.'}, {'measure': 'Number of Weight Loss and Weight Management Appointments Completed', 'timeFrame': '6 and 12 months after trial enrollment', 'description': 'The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'availIpds': [{'id': 'doi:10.7910/DVN/LZUTU0', 'url': 'https://doi.org/10.7910/DVN/LZUTU0', 'type': 'Individual Participant Data Set'}, {'id': 'doi:10.7910/DVN/LZUTU0', 'url': 'https://doi.org/10.7910/DVN/LZUTU0', 'type': 'Analytic Code'}], 'references': [{'pmid': '38147326', 'type': 'BACKGROUND', 'citation': 'Doyle J, Alsan M, Skelley N, Lu Y, Cawley J. Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Feb 1;184(2):154-163. doi: 10.1001/jamainternmed.2023.6670.'}]}, 'descriptionModule': {'briefSummary': 'This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.', 'detailedDescription': 'This is a pragmatic, prospective, randomized controlled trial of Geisinger\'s Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group).\n\nApproximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the "Begin Now" group. The control group will begin the program after 6 months: the "Begin Later" group. Approximately 2000 household members will be included in the data-only portion of the research.\n\nOutcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months\n* Food insecure based on a two-question survey instrument\n* Age \\> 17 \\& Age \\<86\n* Living within geographic reach of the program (Lewistown, PA and Scranton, PA)\n\nExclusion Criteria:\n\n* Already enrolled in FFF in Shamokin\n* Not English speaking (working on changing this as the program evolves)\n* On hospice or palliative care\n* Acute or chronic psychosis\n* Resides in a facility which provides meals\n* Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including:\n\n * Cancer; active treatment\n * Steroid dependent asthma/ COPD/ emphysema\n * Steroid dependent Colitis\n * Chronic Kidney Disease with GFR\\< 30 mg/mmol\n * Celiac disease\n * Cirrhosis\n * Steroid dependent arthritis'}, 'identificationModule': {'nctId': 'NCT03718832', 'briefTitle': 'Fresh Food Farmacy: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Fresh Food Farmacy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018-0297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group-Begin Now', 'description': 'Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).', 'interventionNames': ['Other: Fresh Food Farmacy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group-Begin Later', 'description': 'Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).'}], 'interventions': [{'name': 'Fresh Food Farmacy', 'type': 'OTHER', 'description': 'Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.', 'armGroupLabels': ['Treatment Group-Begin Now']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17044', 'city': 'Lewistown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fresh Food Farmacy', 'geoPoint': {'lat': 40.59924, 'lon': -77.57138}}, {'zip': '18508', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fresh Food Farmacy', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}], 'overallOfficials': [{'name': 'John Bulger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}, {'name': 'Joseph J Doyle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIT Sloan School of Management'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Available pending approval from the IRB and after primary publication.', 'ipdSharing': 'YES', 'description': 'Deidentified data at the subject level, pending approval from the IRB and Geisinger.', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John B Bulger, DO', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}, {'name': 'Cornell University', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Geisinger Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Health Officer, GIO', 'investigatorFullName': 'John B Bulger, DO', 'investigatorAffiliation': 'Geisinger Clinic'}}}}