Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT00902694
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gdaumit@jhmi.edu', 'phone': '410-614-6460', 'title': 'Gail Daumit, MD, MHS', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline through 18 months', 'eventGroups': [{'id': 'EG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'deathsNumAffected': 2, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'deathsNumAffected': 3, 'seriousNumAffected': 47}], 'seriousEvents': [{'term': 'psychiatric hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 51, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'medical hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight Loss in Kilograms (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'baseline to 6 month change', 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.5'}]}]}, {'title': 'baseline to 18 month change', 'categories': [{'measurements': [{'value': '-3.4', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-2.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '1.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.4', 'groupDescription': '6 month intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '-1.2', 'groupDescription': '18 month intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 and 18 months', 'description': 'Change is from baseline to 6 months and baseline to 18 months', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minutes Cycled During Cycle Ergometry Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '6.95', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '7.12', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': '18 month', 'categories': [{'measurements': [{'value': '7.19', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '6.79', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cycle ergometry test was not completed for those who completed data collection off-site where no bicycle ergometer was available. Results are not modeled.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference in Centimeters (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'baseline to 6 month change', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-0.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.7'}]}]}, {'title': 'baseline to 18 month change', 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '-0.7'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '0.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '-0.4', 'groupDescription': '6 month intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.3', 'groupDescription': '18 month intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in waist circumference in centimeters (cm) from baseline to 18 months', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported for those who completed this measure at these follow-up data points.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic and Diastolic Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'baseline to 6 month systolic change', 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-0.2'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '-0.4'}]}]}, {'title': 'baseline to 6 month diastolic change', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '0.7'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '0.3'}]}]}, {'title': 'baseline to 18 month systolic change', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '1.3'}, {'value': '-2.7', 'groupId': 'OG001', 'lowerLimit': '-4.8', 'upperLimit': '-0.7'}]}]}, {'title': 'baseline to 18 month diastolic change', 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.9'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '2.4', 'groupDescription': '6 month systolic intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.1', 'groupDescription': '6 month diastolic intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '4.8', 'groupDescription': '18 month systolic intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.4', 'groupDescription': '18 month diastolic intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months', 'unitOfMeasure': 'mmhg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported for those who completed this measure at these follow-up data points.'}, {'type': 'SECONDARY', 'title': 'Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'baseline to 6 month total chol change', 'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '0.2'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-6.8', 'upperLimit': '3.0'}]}]}, {'title': 'baseline to 18 month total chol change', 'categories': [{'measurements': [{'value': '-5.6', 'groupId': 'OG000', 'lowerLimit': '-11.8', 'upperLimit': '0.6'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '7.1'}]}]}, {'title': 'baseline to 6 month LDL chol change', 'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '0.5'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-7.2', 'upperLimit': '2.1'}]}]}, {'title': 'baseline to 18 month LDL chol change', 'categories': [{'measurements': [{'value': '-5.5', 'groupId': 'OG000', 'lowerLimit': '-10.7', 'upperLimit': '-0.2'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-7.6', 'upperLimit': '5.8'}]}]}, {'title': 'baseline to 6 month HDL chol change', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '2.8'}]}]}, {'title': 'baseline to 18 month HDL chol change', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2.3'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '1.7'}]}]}, {'title': 'baseline to 6 month TRIG change', 'categories': [{'measurements': [{'value': '-6.3', 'groupId': 'OG000', 'lowerLimit': '-16.6', 'upperLimit': '3.9'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-15.6', 'upperLimit': '14.0'}]}]}, {'title': 'baseline to 18 month TRIG change', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-15.1', 'upperLimit': '22.1'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '-12.4', 'upperLimit': '22.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '4.1', 'groupDescription': '6 month total chol intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '4.4', 'groupDescription': '18 month total chol intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '5.1', 'groupDescription': '6 month LDL chol intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-13.1', 'ciUpperLimit': '3.9', 'groupDescription': '18 month LDL chol intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '1.7', 'groupDescription': '6 month HDL chol intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '3.1', 'groupDescription': '18 month HDL intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '12.4', 'groupDescription': '6 month TRIG intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-27.0', 'ciUpperLimit': '23.9', 'groupDescription': '18 month TRIG intervention versus control', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported for those who completed this measure at these follow-up data points.'}, {'type': 'SECONDARY', 'title': 'Framingham Cardiovascular Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.0999', 'spread': '0.1027', 'groupId': 'OG000'}, {'value': '0.0989', 'spread': '0.0924', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '0.1029', 'spread': '0.1093', 'groupId': 'OG000'}, {'value': '0.0991', 'spread': '0.0953', 'groupId': 'OG001'}]}]}, {'title': '18 month', 'categories': [{'measurements': [{'value': '0.1035', 'spread': '0.0972', 'groupId': 'OG000'}, {'value': '0.0978', 'spread': '0.0925', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only included data for those participants who had all variables in calculation equation. Not modeled'}, {'type': 'SECONDARY', 'title': 'Health Status as Measured by the SF-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'Baseline PCS score', 'categories': [{'measurements': [{'value': '45.1', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': '6 months PCS Score', 'categories': [{'measurements': [{'value': '45.5', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': '18 months PCS score', 'categories': [{'measurements': [{'value': '46.2', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline MCS score', 'categories': [{'measurements': [{'value': '45.0', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': '6 months MCS score', 'categories': [{'measurements': [{'value': '46.2', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': '18 months MCS score', 'categories': [{'measurements': [{'value': '45.1', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Subscale score ranges from 0-100 with higher scores indicating better physical or mental health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported for those who completed this measure at these follow-up data points.'}, {'type': 'SECONDARY', 'title': 'Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.7', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '18.7', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '18.7', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Total score range between 0 and 60, higher scores indicating more depressive symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Censored per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.\n\nACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight\n\nControl: group health classes quarterly with topics not related to weight'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'primary psychiatric diagnosis', 'classes': [{'categories': [{'title': 'schizophrenia', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'schizoaffective disorder', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'bipolar disorder', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'major depressive disorder', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'other', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2009-05-13', 'resultsFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-10', 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight Loss in Kilograms (kg)', 'timeFrame': '6 and 18 months', 'description': 'Change is from baseline to 6 months and baseline to 18 months'}], 'secondaryOutcomes': [{'measure': 'Minutes Cycled During Cycle Ergometry Testing', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.'}, {'measure': 'Change in Waist Circumference in Centimeters (cm)', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in waist circumference in centimeters (cm) from baseline to 18 months'}, {'measure': 'Change in Systolic and Diastolic Blood Pressure (mmHg)', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months'}, {'measure': 'Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months'}, {'measure': 'Framingham Cardiovascular Risk Score', 'timeFrame': 'Measured at baseline, 6 and 18 months', 'description': 'Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke'}, {'measure': 'Health Status as Measured by the SF-12', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Subscale score ranges from 0-100 with higher scores indicating better physical or mental health.'}, {'measure': 'Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'Baseline, 6 and 18 months', 'description': 'Total score range between 0 and 60, higher scores indicating more depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Serious Mental Illness', 'Weight Loss'], 'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '21144025', 'type': 'BACKGROUND', 'citation': 'Casagrande SS, Jerome GJ, Dalcin AT, Dickerson FB, Anderson CA, Appel LJ, Charleston J, Crum RM, Young DR, Guallar E, Frick KD, Goldberg RW, Oefinger M, Finkelstein J, Gennusa JV 3rd, Fred-Omojole O, Campbell LM, Wang NY, Daumit GL. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial. BMC Psychiatry. 2010 Dec 13;10:108. doi: 10.1186/1471-244X-10-108.'}, {'pmid': '28398006', 'type': 'DERIVED', 'citation': 'Janssen EM, Jerome GJ, Dalcin AT, Gennusa JV 3rd, Goldsholl S, Frick KD, Wang NY, Appel LJ, Daumit GL. A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial. Obesity (Silver Spring). 2017 Jun;25(6):1006-1013. doi: 10.1002/oby.21836. Epub 2017 Apr 11.'}, {'pmid': '23517118', 'type': 'DERIVED', 'citation': 'Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd, Oefinger M, Crum RM, Charleston J, Casagrande SS, Guallar E, Goldberg RW, Campbell LM, Appel LJ. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013 Apr 25;368(17):1594-602. doi: 10.1056/NEJMoa1214530. Epub 2013 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether a behavioral weight loss intervention including dietary counseling and exercise is effective in helping people with serious mental illnesses lose weight.', 'detailedDescription': 'The objective of this study is to perform a randomized clinical trial (ACHIEVE) to definitively test the efficacy of an innovative, practical intervention to accomplish weight loss in overweight and obese persons with SMI. This multi-site trial will enroll consumers with SMI who attend ten psychiatric rehabilitation centers in Maryland and randomize participants to the ACHIEVE intervention or control. Intervention participants will receive group and individual weight loss counseling sessions and group physical activity classes. Co-primary outcomes will be change in weight from baseline to 6 and 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Age 18 and older;\n\n* Overweight, defined by Body Mass Index at least 25.0 kg/m2;\n* Able and willing to give informed consent and participate in the intervention;\n* On the same psychiatric medications within the 30 days before baseline weight (dose changes allowed;)\n* Able to attend at least 2 intervention sessions per week during initial 6-month phase;\n\nExclusion criteria\n\n* Contraindication to weight loss\n\n * Receiving active cancer treatment (radiation/chemotherapy)\n * Liver failure\n * History of anorexia nervosa;\n* Cardiovascular event (unstable angina, myocardial infarction) within previous 6 months;\n* Prior or planned bariatric surgery;\n\nUse of prescription weight loss medication or over-the-counter orlistat within 3 months\n\nif participant does not agree to stop taking it;\n\n* Twenty pound or greater weight loss in 3 months prior to baseline, as documented by staff measurement;\n* Inability to walk to participate in exercise class;\n* Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician;\n* Alcohol or substance use disorder either: 1) active and determined to be incompatible with participation in the intervention through discussion with program staff; or 2) new abstinence from alcohol or substance use disorder in past 30 days;\n* Planning to leave rehabilitation center within 6 months or move out of geographic area within 18 months;\n* Investigator judgment (e.g., for concerns over safety, adherence or follow-up);\n* Weight greater than 400 pounds.'}, 'identificationModule': {'nctId': 'NCT00902694', 'acronym': 'ACHIEVE', 'briefTitle': 'Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation', 'orgStudyIdInfo': {'id': 'R01MH080964', 'link': 'https://reporter.nih.gov/quickSearch/R01MH080964', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH080964', 'link': 'https://reporter.nih.gov/quickSearch/R01MH080964', 'type': 'NIH'}, {'id': 'DAHBR 96-BHB'}, {'id': 'NIMH R01MH080964'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACHIEVE Intervention', 'description': 'Group and individual weight counseling and group physical activity classes for 18 months.', 'interventionNames': ['Behavioral: ACHIEVE Intervention']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Control arm receives group health classes quarterly with topics not related to weight', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'ACHIEVE Intervention', 'type': 'BEHAVIORAL', 'description': 'Group and individual weight loss counseling and group physical activity classes for 18 months', 'armGroupLabels': ['ACHIEVE Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'group health classes quarterly with topics not related to weight', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Prohealth', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Gail L. Daumit, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}