Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-24 @ 5:43 AM
Study NCT ID:
NCT02454127
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdansinger@tuftsmedicalcenter.org', 'phone': '617-636-5000', 'title': 'Michael Dansinger, MD', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The protocol provided dietary advice rather than food. The attrition rate was 35% to 50% in each group. Missing data were replaced with baseline data for intent-to-treat analysis. Long-term safety beyond 1-year was not assessed.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Clinically significant adverse events likely related to dietary adherence', 'eventGroups': [{'id': 'EG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '7.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline body weight at 1 year, measured in kilograms', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '23', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '35', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '24', 'groupId': 'OG002'}, {'value': '-10.8', 'spread': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change in total cholesterol from baseline at 1 year, measured in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline data.'}, {'type': 'SECONDARY', 'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '24', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '34', 'groupId': 'OG001'}, {'value': '-9.3', 'spread': '27', 'groupId': 'OG002'}, {'value': '-12.6', 'spread': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline LDL cholesterol at 1 year, measured in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '6.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline HDL cholesterol at 1 year, measured in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values.'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '84', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '147', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '61', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline triglycerides at 1 year, measured in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values'}, {'type': 'SECONDARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '30', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '18', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '19', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline glucose at 1 year, measured in mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values.'}, {'type': 'SECONDARY', 'title': 'Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '14', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '6.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline insulin at 1 year, measured in microIU/mL', 'unitOfMeasure': 'microIU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'OG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'OG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'OG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-0.88', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Change from baseline high-sensitivity CRP at 1 year, measured in mg/L', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis. Missing data were replaced with baseline values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'FG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'FG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'FG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)\n\nAtkins Diet: Dietary counseling for 1 year'}, {'id': 'BG001', 'title': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)\n\nZone Diet: Dietary counseling for 1 year'}, {'id': 'BG002', 'title': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)\n\nWeight Watchers Diet: Dietary counseling for 1 year'}, {'id': 'BG003', 'title': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)\n\nOrnish Diet: Dietary counseling for 1 year'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '12', 'groupId': 'BG000'}, {'value': '51', 'spread': '9', 'groupId': 'BG001'}, {'value': '49', 'spread': '10', 'groupId': 'BG002'}, {'value': '49', 'spread': '12', 'groupId': 'BG003'}, {'value': '49', 'spread': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2015-05-20', 'resultsFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '1 year', 'description': 'Change from baseline body weight at 1 year, measured in kilograms'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': '1 year', 'description': 'Change in total cholesterol from baseline at 1 year, measured in mg/dL'}, {'measure': 'LDL Cholesterol', 'timeFrame': '1 year', 'description': 'Change from baseline LDL cholesterol at 1 year, measured in mg/dL'}, {'measure': 'HDL Cholesterol', 'timeFrame': '1 year', 'description': 'Change from baseline HDL cholesterol at 1 year, measured in mg/dL'}, {'measure': 'Triglycerides', 'timeFrame': '1 year', 'description': 'Change from baseline triglycerides at 1 year, measured in mg/dL'}, {'measure': 'Glucose', 'timeFrame': '1 year', 'description': 'Change from baseline glucose at 1 year, measured in mg/dL'}, {'measure': 'Insulin', 'timeFrame': '1 year', 'description': 'Change from baseline insulin at 1 year, measured in microIU/mL'}, {'measure': 'C-reactive Protein', 'timeFrame': '1 year', 'description': 'Change from baseline high-sensitivity CRP at 1 year, measured in mg/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nutrition', 'popular diets', 'weight loss', 'lifestyle', 'counseling'], 'conditions': ['Obesity', 'Cardiovascular Disease', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '15632335', 'type': 'RESULT', 'citation': 'Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.'}]}, 'descriptionModule': {'briefSummary': 'A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.', 'detailedDescription': 'Objective: To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction.\n\nDesign, Setting, and Participants: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.\n\nIntervention: A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence.\n\nMain Outcome Measures: One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report. Outcome measures included body weight, total cholesterol, LDL-C, HDL-C, triglycerides, hsCRP, insulin, glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 27-42;\n* At least one metabolic cardiac risk factor\n\nExclusion Criteria:\n\n* Age under 18 years;\n* Insulin therapy;\n* Unstable chronic illness;\n* Unwilling to follow dietary advice'}, 'identificationModule': {'nctId': 'NCT02454127', 'briefTitle': 'Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'DANS0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atkins Diet', 'description': 'Atkins Diet (dietary counseling)', 'interventionNames': ['Behavioral: Atkins Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zone Diet', 'description': 'Zone Diet (dietary counseling)', 'interventionNames': ['Behavioral: Zone Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Watchers Diet', 'description': 'Weight Watchers Diet (dietary counseling)', 'interventionNames': ['Behavioral: Weight Watchers Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ornish Diet', 'description': 'Ornish Diet (dietary counseling)', 'interventionNames': ['Behavioral: Ornish Diet']}], 'interventions': [{'name': 'Atkins Diet', 'type': 'BEHAVIORAL', 'description': 'Dietary counseling for 1 year', 'armGroupLabels': ['Atkins Diet']}, {'name': 'Zone Diet', 'type': 'BEHAVIORAL', 'description': 'Dietary counseling for 1 year', 'armGroupLabels': ['Zone Diet']}, {'name': 'Weight Watchers Diet', 'type': 'BEHAVIORAL', 'description': 'Dietary counseling for 1 year', 'armGroupLabels': ['Weight Watchers Diet']}, {'name': 'Ornish Diet', 'type': 'BEHAVIORAL', 'description': 'Dietary counseling for 1 year', 'armGroupLabels': ['Ornish Diet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael L Dansinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Peer-reviewed publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}