Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-29 @ 2:47 AM
Study NCT ID:
NCT00955903
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jard@wakehealth.edu', 'phone': '3367169837', 'title': 'Jamy Ard, MD', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This trial was completed in older adults (age 65+) with at least one major risk factor for heart disease.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet', 'otherNumAtRisk': 55, 'otherNumAffected': 36, 'seriousNumAtRisk': 55, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions', 'otherNumAtRisk': 54, 'otherNumAffected': 36, 'seriousNumAtRisk': 54, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet', 'otherNumAtRisk': 55, 'otherNumAffected': 40, 'seriousNumAtRisk': 55, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General, Constitutional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle and bone issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric and mood changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Joint surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate and blood pressure abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complications related to surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Abdominal Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions'}, {'id': 'OG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-192.6', 'spread': '185.2', 'groupId': 'OG000'}, {'value': '-21.9', 'spread': '173.7', 'groupId': 'OG001'}, {'value': '-275', 'spread': '189.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 1 year', 'description': 'Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year', 'unitOfMeasure': 'Cubic cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiometabolic Risk Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions'}, {'id': 'OG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 1 year', 'description': 'We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Change/Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions'}, {'id': 'OG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 1 year', 'description': 'The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions'}, {'id': 'FG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Weight Loss', 'description': 'Participants receive Exercise Only and Reduced Calorie Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nReduced Calorie Diet: Participants will follow a reduced calorie diet'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants receive Exercise Only Intervention\n\nExercise Only: Participants will participate in supervised exercise sessions'}, {'id': 'BG002', 'title': 'Weight Maintenance', 'description': 'Participants receive Exercise Only and a Weight Maintenance Diet Interventions\n\nExercise Only: Participants will participate in supervised exercise sessions\n\nWeight Maintenance Diet: Participants will follow a weight maintenance diet'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '70.3', 'spread': '4.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2009-08-06', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2009-08-07', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Abdominal Fat Mass', 'timeFrame': 'Baseline to 1 year', 'description': 'Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year'}], 'secondaryOutcomes': [{'measure': 'Cardiometabolic Risk Factors', 'timeFrame': 'Baseline to 1 year', 'description': 'We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year'}, {'measure': 'Weight Change/Maintenance', 'timeFrame': 'Baseline to 1 year', 'description': 'The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucose', 'insulin', 'lipids', 'C-reactive protein', 'adiponectin', 'leptin', 'TNF alpha', 'IL-6', 'Quality of Life', 'functional status'], 'conditions': ['Obesity', 'Diabetes', 'Hypertension', 'Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '35654771', 'type': 'DERIVED', 'citation': 'Senkus KE, Crowe-White KM, Bolland AC, Locher JL, Ard JD. Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention. Nutr Diabetes. 2022 Jun 2;12(1):30. doi: 10.1038/s41387-022-00207-1.'}, {'pmid': '35471192', 'type': 'DERIVED', 'citation': 'Senkus KE, Crowe-White KM, Locher JL, Ard JD. Relative fat mass assessment estimates changes in adiposity among female older adults with obesity after a 12-month exercise and diet intervention. Ann Med. 2022 Dec;54(1):1160-1166. doi: 10.1080/07853890.2022.2067352.'}, {'pmid': '34486528', 'type': 'DERIVED', 'citation': 'Bragg AE, Crowe-White KM, Ellis AC, Studer M, Phillips F, Samsel S, Parton J, Locher JL, Ard JD. Changes in Cardiometabolic Risk Among Older Adults with Obesity: An Ancillary Analysis of a Randomized Controlled Trial Investigating Exercise Plus Weight Maintenance and Exercise Plus Intentional Weight Loss by Caloric Restriction. J Acad Nutr Diet. 2022 Feb;122(2):354-362. doi: 10.1016/j.jand.2021.07.009. Epub 2021 Sep 1.'}, {'pmid': '31145045', 'type': 'DERIVED', 'citation': 'Crowe-White KM, Ellis AC, Mehta T, Locher JL, Ard JD. Dietary Quality Assessed by the HEI-2010 and Biomarkers of Cardiometabolic Disease: An Exploratory Analysis. J Am Coll Nutr. 2019 Sep-Oct;38(7):640-647. doi: 10.1080/07315724.2019.1580168. Epub 2019 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 65 years of age\n* BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)\n\nExclusion Criteria:\n\n* difficulties chewing or swallowing food\n* digestive diseases that may affect the ability to follow a high fiber diet\n* cognitive impairment\n* depression\n* recent weight change (+/- 10 lbs in the last 12 months)\n* poorly controlled blood pressure\n* history of non-skin cancer in last 5 years\n* cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure\n* major liver dysfunction\n* current smoker or quit less than months prior\n* history of prior surgical procedures for weight control or liposuction\n* use of estrogen or testosterone replacement therapy\n* current use of insulin or sulfonylurea agents\n* current use of corticosteroids \\> 5 days/month on average\n* current use of medications for treatment of psychosis or manic-depressive illness\n* use of weight-loss medications in previous 3 months\n* dependence on others for food procurement or preparation\n* ischemic changes on exercise treadmill test'}, 'identificationModule': {'nctId': 'NCT00955903', 'acronym': 'CROSSROADS', 'briefTitle': 'Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults', 'orgStudyIdInfo': {'id': 'F090430012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight Loss', 'description': 'Participants receive Exercise and Reduced Calorie Diet Interventions', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Reduced Calorie Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants receive Exercise Intervention', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Maintenance', 'description': 'Participants receive Exercise and a Weight Maintenance Diet Interventions', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Weight Maintenance Diet']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will participate in supervised exercise sessions', 'armGroupLabels': ['Control', 'Weight Loss', 'Weight Maintenance']}, {'name': 'Reduced Calorie Diet', 'type': 'BEHAVIORAL', 'description': 'Participants will follow a reduced calorie diet', 'armGroupLabels': ['Weight Loss']}, {'name': 'Weight Maintenance Diet', 'type': 'BEHAVIORAL', 'description': 'Participants will follow a weight maintenance diet', 'armGroupLabels': ['Weight Maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Jamy D Ard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Julie Locher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jamy Ard, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}