Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00132132
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000079102', 'term': 'Empowerment'}], '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': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shirley.gonzalez@steward.org', 'phone': '617-926-0114', 'title': 'Dr. Shirley Gonzalez', 'organization': 'SEMC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A limitation of the study is the lost to follow up. However, our rate of lost to follow up is comparable to rates seen in similar studies in this field'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Program', 'description': 'This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care/Control', 'description': 'Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in BMI (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'The intervention group attended monthly, 4 hour sessions for one year'}, {'id': 'OG001', 'title': 'Standard of Care/Control Group', 'description': 'The Standard of Care/Control group received visits to primary care provider and referral to nutritionist'}], 'classes': [{'title': 'Unadjusted per-protocol change in BMI', 'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-2.21', 'upperLimit': '0.72'}, {'value': '1.33', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '2.48'}]}]}, {'title': 'Adjusted for age per-protocol change in BMI', 'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '1.04'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '1.93'}]}]}, {'title': 'Adjusted for age/paternal education change in BMI', 'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-1.19', 'upperLimit': '0.44'}, {'value': '1.28', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '1.97'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This analysis is the per protocol unadjusted value', 'testedNonInferiority': False}, {'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Age adjusted per protocol', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-15 months', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With BMI Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'The intervention group attended monthly, 4 hour sessions for one year'}, {'id': 'OG001', 'title': 'Standard of Care/Control Group', 'description': 'The Standard of Care/Control group received visits to primary care provider and referral to nutritionist'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12-15 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Program', 'description': 'This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).'}, {'id': 'FG001', 'title': 'Standard of Care/Control', 'description': 'Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Program', 'description': 'This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).'}, {'id': 'BG001', 'title': 'Standard of Care/Control', 'description': 'Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2005-08-17', 'resultsFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2005-08-18', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-22', 'studyFirstPostDateStruct': {'date': '2005-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI (Body Mass Index)', 'timeFrame': 'Baseline, 12-15 months'}, {'measure': 'Percentage of Participants With BMI Reduction', 'timeFrame': 'Baseline, 12-15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BMI', 'obesity', 'behavioral intervention', 'longterm randomized controlled trial', 'exercise', 'empowerment', 'nutrition'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.', 'detailedDescription': 'This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI \\> 85%.\n\nThe intervention group will:\n\n* have baseline and follow up blood work (fasting insulin, glucose, lipid panel)\n* have baseline and follow up BMI, blood pressure measurements\n* see a dietician-minimum of three visits during study\n* attend monthly, four hour sessions. These sessions include:\n\n 1. registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)\n 2. one hour of exercise (including strength training)\n 3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic\n 4. projects/games\n 5. empowerment tools such as leading exercises and presenting food labels for discussion\n\nThe control group will have:\n\n1. baseline and follow up blood work (fasting insulin, glucose, lipid panel)\n2. baseline and follow up BMI and blood pressure measurements\n3. visits to dietician (minimum of three visits during study)\n4. standard education on nutrition and exercise given during office visit with primary care doctor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 10-20 years\n* BMI\\>85%\n\nExclusion Criteria:\n\n* Endocrine disorder\n* On psychotropic medications'}, 'identificationModule': {'nctId': 'NCT00132132', 'briefTitle': 'Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)', 'organization': {'class': 'OTHER', 'fullName': "Steward St. Elizabeth's Medical Center of Boston, Inc."}, 'officialTitle': 'Type 2 Diabetes and Obesity Pediatric Prevention Project', 'orgStudyIdInfo': {'id': '00203 (number assigned by IRB)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).', 'interventionNames': ['Behavioral: Behavioral education program']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care/Control', 'description': 'Education on physical activity and nutrition in a primary care office setting'}], 'interventions': [{'name': 'Behavioral education program', 'type': 'BEHAVIORAL', 'description': 'Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Caritas St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Shirley Gonzalez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Steward St. Elizabeth's Medical Center of Boston, Inc."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}