Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00827593
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-12', 'studyFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '3, 6, 12 months'}], 'secondaryOutcomes': [{'measure': 'cost-effectiveness', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23404824', 'type': 'DERIVED', 'citation': 'Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 30-65 years\n* BMI between 27-50 kg/m2\n* Written approval/consent from primary health care provider\n\nExclusion Criteria:\n\n* Unable to walk 2 blocks without stopping.\n* Currently participating in a weight loss program or taking weight loss medication.\n* Participated in a weight loss program in the last year\n* Took weight loss medication in the last 6 months.\n* Participated in Weight Watchers in last 2 years.\n* Lost \\>=5% of body weight during 6 months prior to screening.\n* Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.\n* Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.\n* Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.'}, 'identificationModule': {'nctId': 'NCT00827593', 'briefTitle': 'Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches', 'organization': {'class': 'OTHER', 'fullName': 'Baruch College City University of New York'}, 'officialTitle': 'Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches', 'orgStudyIdInfo': {'id': '070601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard behavioral weight loss', 'description': 'University-based behavioral weight loss treatment', 'interventionNames': ['Behavioral: Standard behavioral weight loss treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Watchers', 'description': 'Weight Watchers program', 'interventionNames': ['Behavioral: Weight Watchers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Treatment', 'description': 'University-based behavioral weight loss treatment followed by Weight Watchers', 'interventionNames': ['Behavioral: Combined Treatment']}], 'interventions': [{'name': 'Standard behavioral weight loss treatment', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 months of university-based behavioral weight loss treatment', 'armGroupLabels': ['Standard behavioral weight loss']}, {'name': 'Weight Watchers', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 months of Weight Watchers', 'armGroupLabels': ['Weight Watchers']}, {'name': 'Combined Treatment', 'type': 'BEHAVIORAL', 'description': 'Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers', 'armGroupLabels': ['Combined Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Baruch College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Angela M Pinto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baruch College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baruch College City University of New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychology', 'investigatorFullName': 'Angela M Pinto', 'investigatorAffiliation': 'Baruch College City University of New York'}}}}