Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05586269
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2022-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allison.wu@childrens.harvard.edu', 'phone': '6173556058', 'title': 'Dr. Allison Wu', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Consistent with the goal of the pilot phase I study, the analysis is descriptive. This phase I study was not intended to be powered to detect changes in the secondary outcomes. Secondary outcomes were collected to determine the feasibility of the assessments.'}}, 'adverseEventsModule': {'timeFrame': 'Six weeks for each intervention.', 'description': 'Safety Population included all participants who received at least one meal kit or the newsletter + food pantry referral.', 'eventGroups': [{'id': 'EG000', 'title': 'Meal Kit Delivery: Caregivers', 'description': 'Caregivers who received weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Meal Kit Delivery: Children', 'description': 'Children who received weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Newsletter + Food Pantry Referral: Caregivers', 'description': 'Caregivers who received a newsletter and food pantry referral.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Newsletter + Food Pantry Referral: Children', 'description': 'Children who received a newsletter and food pantry referral.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Study Feasibility: Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Both Arms', 'description': 'The total sample is included as the proportion of eligible participants, including children and caregivers, who were recruited and enrolled in the intervention was assessed prior to randomization to one of two arms.'}], 'classes': [{'categories': [{'title': 'Enrolled', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}, {'title': 'Declined to enroll', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months to baseline', 'description': 'Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who met eligibility criteria after being screened.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'categories': [{'title': 'Number of participants enrolled (February)', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Number of participants enrolled (March)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants enrolled per month, then subject to randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants (caregivers and children) who consented to participate in the study. Randomization occurred by caregiver after completing the consent. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver', 'description': 'Caregivers receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children', 'description': 'Children receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG002', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver', 'description': 'Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}, {'id': 'OG003', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children', 'description': 'Children receive a newsletter and food pantry referral. After the second study visit, they receive healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'First study visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Participants remaining in study visit', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}, {'title': 'Participants lost to follow up in study visit', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Second study visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Participants remaining in study visit', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Participants lost to follow up in study visit', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Third study visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Participants remaining in study visit', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Participants lost to follow up in study visit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).', 'description': 'Number of participants retained at each study visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Number of participants who reported receipt of all six weeks of meal kit delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with assessment data at the third study visit.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Adherence - Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Caregivers who prepared 7-12 recipes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Caregivers who prepared 3-6 recipes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Caregivers who prepared 1-2 recipes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Caregivers who did not prepare any recipe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Total number of recipes prepared by caregivers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All caregivers with assessment data at the third study visit.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Adherence - Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Number of children who tasted/ate food from the meal kit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All caregivers with assessment data at the third study visit.'}, {'type': 'PRIMARY', 'title': 'Study Feasibility: Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Survey/Assessments', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Planned assessments completed after visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Survey/Assessments', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Planned assessments completed after visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Survey/Assessments', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Planned assessments completed after visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Survey/Assessments', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'Proportion of planned assessments completed at each study visit', 'unitOfMeasure': 'Survey/Assessments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Survey/Assessments', 'denomUnitsSelected': 'Survey/Assessments', 'populationDescription': 'The first study visit included a baseline demographic survey, 2 child assessments, and 1 caregiver assessment. The second study visit included 2 child assessments and 1 parent assessment. The third study visit included 2 child assessments, 1 parent assessment, and 1 satisfaction questionnaire. The "Meal Kit Delivery, Then Newsletter + Food Pantry Referral" arm included 14 caregivers and 15 children (one pair of siblings), thus the discrepancy between total planned assessments in each arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Household Food Insecurity at the First Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High food security', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Marginal food security', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Low food security', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Very low food security', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the baseline first study visit (baseline)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who reported household-level food security at baseline study visit 1 (baseline).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Household Food Insecurity at Second Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Marginal food security', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Low food security', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Very low food security', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who reported household-level food security at study visit 2 (week 6-8).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Household Food Insecurity at Third Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High food security', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Marginal food security', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Low food security', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Very low food security', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who reported household-level food security at third study visit (week 14-16).'}, {'type': 'SECONDARY', 'title': 'Change in BMI For Children With BMI Assessments At All Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers', 'description': 'Caregivers receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers', 'description': 'Caregivers receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'BMI at Baseline', 'categories': [{'measurements': [{'value': '26.29', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '24.82', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'BMI at Visit 2', 'categories': [{'measurements': [{'value': '26.64', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '24.67', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'BMI at Visit 3', 'categories': [{'measurements': [{'value': '26.54', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '24.66', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Visit 2', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Visit 3', 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Change from Visit 2 and Visit 3', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'Weight and height were combined to report BMI in kg/m\\^2 based on Centers for Disease Control growth curves.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with BMI data at three study visits.'}, {'type': 'SECONDARY', 'title': 'Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'BMIp95 at Baseline', 'categories': [{'measurements': [{'value': '117.5', 'spread': '12', 'groupId': 'OG000'}, {'value': '113.3', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'BMIp95 at Visit 2', 'categories': [{'measurements': [{'value': '118.5', 'spread': '12', 'groupId': 'OG000'}, {'value': '111.8', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'BMIp95 at Visit 3', 'categories': [{'measurements': [{'value': '117.3', 'spread': '12', 'groupId': 'OG000'}, {'value': '111.0', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Visit 2', 'categories': [{'measurements': [{'value': '1.0', 'spread': '7', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Visit 3', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '8', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Change from Visit 2 to Visit 3', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits', 'unitOfMeasure': 'percentage of the 95th percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with BMI data at all three study visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Prime Diet Quality Score at Each Study Visit: Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Child Prime Diet Quality Score (PDQS) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '6', 'groupId': 'OG000'}, {'value': '39', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Child Prime Diet Quality Score (PDQS) at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '7', 'groupId': 'OG000'}, {'value': '41', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Child Prime Diet Quality Score (PDQS) at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '7', 'groupId': 'OG000'}, {'value': '43', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': "The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with dietary data at study visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Prime Diet Quality Score at Each Study Visit: Caregiver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Caregiver Prime Diet Quality Score (PDQS) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '6', 'groupId': 'OG000'}, {'value': '42', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Caregiver Prime Diet Quality Score (PDQS) at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '6', 'groupId': 'OG000'}, {'value': '46', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Caregiver Prime Diet Quality Score (PDQS) at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '5', 'groupId': 'OG000'}, {'value': '47', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': "The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Parents with dietary data at study visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Reported Mealtime Behavior at First Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Never/Less than once per week', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Once per week', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2-4 times per week', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5-6 times per week', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Everyday', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline first study visit (baseline)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with parent-reported data on mealtime behavior.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Reported Mealtime Behavior at Second Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Never/Less than once per week', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Once per week', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2-4 times per week', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5-6 times per week', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Everyday', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with parent-reported mealtime behavior data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Reported Mealtime Behavior at Third Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'Never/Less than once per week', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Once per week', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2-4 times per week', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5-6 times per week', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Everyday', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Children with parent-reported mealtime behavior data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Perceived Stress at First Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High perceived stress', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate perceived stress', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Low perceived stress', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline first study visit (baseline)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers with perceived stress data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Perceived Stress at Second Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High perceived stress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate perceived stress', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Low perceived stress', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers with perceived stress data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Perceived Stress at Third Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Kit Delivery, Then Newsletter + Food Pantry Referral', 'description': 'Dyads receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'OG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kit Delivery', 'description': 'Dyads receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'classes': [{'title': 'High perceived stress', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate perceived stress', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Low perceived stress', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers with perceived stress data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers', 'description': 'Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'FG001', 'title': 'Meal Kits, Then Newsletter + Food Pantry Referral: Children', 'description': 'Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'FG002', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers', 'description': 'Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}, {'id': 'FG003', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kits: Children', 'description': 'Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment was conducted at a primary care clinic between February and March 2023. The first participant was enrolled on February 13, 2023, and the last participant was enrolled on March 9, 2023.', 'preAssignmentDetails': 'Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meal Kits, Then Newsletter + Food Pantry Referral', 'description': 'Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.'}, {'id': 'BG001', 'title': 'Newsletter + Food Pantry Referral, Then Meal Kits', 'description': 'Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Child age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '9', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '9', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '11'}]}]}, {'title': 'Caregiver age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '50'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '50'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Caregivers and children were analyzed separately.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Child sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Child ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregivers and children were analyzed separately.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Child race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregivers and children were analyzed separately.'}, {'title': 'Number of people living in the household', 'classes': [{'title': 'Number of adults 18 years and older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Number of children younger than 18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'persons', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information.'}, {'title': 'Caregiver marital status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Married', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Never married', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Divorced', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Separated', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only caregivers reported marital status.'}, {'title': 'Total annual household income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than $20,000', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Between $20,000 and $70,000', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than $70,000', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': "Don't know", 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only caregivers reported household income.'}, {'title': 'Highest grade or degree completed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': '8th grade or less', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Some high school', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'High school graduate', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Some college or technical school', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'College graduate', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Postgraduate training or degree', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': "Don't know or prefer not to answer", 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only caregivers reported their highest grade or degree completed.'}, {'title': 'Caregiver relationship to child', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Mother', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Father', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only caregivers reported their relationship to their child.'}], 'populationDescription': 'Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-23', 'size': 120277, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-06T11:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Dyads (caregiver + child) will be randomized to one of two intervention sequences:\n\n1. Meal kit intervention without delay followed by newsletter + pantry referral\n2. Newsletter + pantry referral followed by meal kit intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2022-09-23', 'resultsFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-07', 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Prime Diet Quality Score at Each Study Visit: Children', 'timeFrame': 'At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': "The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality."}, {'measure': 'Total Prime Diet Quality Score at Each Study Visit: Caregiver', 'timeFrame': 'At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': "The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality."}, {'measure': 'Caregiver Reported Mealtime Behavior at First Study Visit', 'timeFrame': 'At baseline first study visit (baseline)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"'}, {'measure': 'Caregiver Reported Mealtime Behavior at Second Study Visit', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"'}, {'measure': 'Caregiver Reported Mealtime Behavior at Third Study Visit', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"'}, {'measure': 'Caregiver Perceived Stress at First Study Visit', 'timeFrame': 'At baseline first study visit (baseline)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress'}, {'measure': 'Caregiver Perceived Stress at Second Study Visit', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress'}, {'measure': 'Caregiver Perceived Stress at Third Study Visit', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:\n\n0-13: low stress 14-26: moderate stress 27-40: high perceived stress'}], 'primaryOutcomes': [{'measure': 'Study Feasibility: Recruitment', 'timeFrame': '2 months to baseline', 'description': 'Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.'}, {'measure': 'Study Feasibility: Randomization', 'timeFrame': 'At baseline', 'description': 'Number of participants enrolled per month, then subject to randomization.'}, {'measure': 'Study Feasibility: Retention', 'timeFrame': 'At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).', 'description': 'Number of participants retained at each study visit'}, {'measure': 'Study Feasibility: Protocol', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Number of participants who reported receipt of all six weeks of meal kit delivery'}, {'measure': 'Study Feasibility: Adherence - Caregivers', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Total number of recipes prepared by caregivers'}, {'measure': 'Study Feasibility: Adherence - Children', 'timeFrame': 'Third study visit (week 14-16)', 'description': 'Number of children who tasted/ate food from the meal kit'}, {'measure': 'Study Feasibility: Assessments', 'timeFrame': 'At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'Proportion of planned assessments completed at each study visit'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Household Food Insecurity at the First Study Visit', 'timeFrame': 'At the baseline first study visit (baseline)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security'}, {'measure': 'Number of Participants With Household Food Insecurity at Second Study Visit', 'timeFrame': 'At second study visit (week 6-8)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security'}, {'measure': 'Number of Participants With Household Food Insecurity at Third Study Visit', 'timeFrame': 'At third study visit (week 14-16)', 'description': 'Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:\n\nZero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security'}, {'measure': 'Change in BMI For Children With BMI Assessments At All Visits', 'timeFrame': 'At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'Weight and height were combined to report BMI in kg/m\\^2 based on Centers for Disease Control growth curves.'}, {'measure': 'Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits', 'timeFrame': 'At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)', 'description': 'BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Insecurity', 'Nutrition Security'], 'conditions': ['Pediatric Obesity', 'Nutrition Disorders', 'Overnutrition, Child', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.', 'detailedDescription': 'Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Child Inclusion Criteria:\n\n* Children \\>=6 years and \\<12 years old with a BMI \\>=95th percentile\n* Children who screen positive on the 2-item Hunger Vital Sign™\n* Children living in a household of \\<=5 people\n* Children living with an English and/or Spanish-speaking caregiver\n* Children living within the EatWell delivery map boundaries in the greater Boston area\n\nChild Exclusion Criteria:\n\n* History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit\n* History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)\n* History of type 1 or 2 diabetes\n* History of solid tumor or bone marrow transplant\n* Enteral tube dependence\n\nThe child's primary caregiver will be eligible for enrollment."}, 'identificationModule': {'nctId': 'NCT05586269', 'briefTitle': 'Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity', 'orgStudyIdInfo': {'id': 'IRB-P00043195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal Kits, Then Newsletter + Food Pantry Referral', 'description': 'Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.', 'interventionNames': ['Behavioral: Meal Kit Delivery', 'Behavioral: Newsletter + Food Pantry Referral']}, {'type': 'EXPERIMENTAL', 'label': 'Newsletter + Food Pantry Referral, Then Meal Kits', 'description': 'Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).', 'interventionNames': ['Behavioral: Meal Kit Delivery', 'Behavioral: Newsletter + Food Pantry Referral']}], 'interventions': [{'name': 'Meal Kit Delivery', 'type': 'BEHAVIORAL', 'otherNames': ['EatWell Meal Kits'], 'description': 'Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\\~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.', 'armGroupLabels': ['Meal Kits, Then Newsletter + Food Pantry Referral', 'Newsletter + Food Pantry Referral, Then Meal Kits']}, {'name': 'Newsletter + Food Pantry Referral', 'type': 'BEHAVIORAL', 'otherNames': ['Standard of Care'], 'description': "Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.", 'armGroupLabels': ['Meal Kits, Then Newsletter + Food Pantry Referral', 'Newsletter + Food Pantry Referral, Then Meal Kits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Allison J Wu, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data can be requested by emailing the PI.', 'ipdSharing': 'YES', 'description': 'Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, Institutional Review Board approval has been obtained, and all necessary data sharing agreements have been executed.', 'accessCriteria': '1. An analysis plan is prepared and approved by the PI/Co-Is,\n2. IRB approval has been obtained, and\n3. All necessary data sharing agreements have been executed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, Gastroenterology and Nutrition, Principal Investigator, Instructor of Pediatrics', 'investigatorFullName': 'Allison Wu', 'investigatorAffiliation': "Boston Children's Hospital"}}}}