Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01165151
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2010-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Group Size in Weight Loss Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2010-07-16', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in weight from baseline to month 12', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'adherence to treatment protocol', 'timeFrame': '12 months', 'description': 'number and proportion of treatment sessions attended'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'weight loss', 'group size'], 'conditions': ['Obesity', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (at least 21 years-old)\n* Health insurance coverage with Capital Health Plan (CHP)\n* Body mass index BMI between 30-45 kg/m2\n\nExclusion Criteria:\n\n* BMI is less than 30 kg/m2 or greater than 45 kg/m2\n* Weight loss \\> 10 pounds in past 6 months\n* Acute or chronic illnesses for which weight loss is contraindicated\n* Unwilling or unable to give informed consent\n* Unwilling to accept random assignment\n* Unwilling or unable to travel to CHP clinic for assessments and groups\n* Likely to relocate out of the area in the next 12 months'}, 'identificationModule': {'nctId': 'NCT01165151', 'briefTitle': 'Impact of Group Size in Weight Loss Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment', 'orgStudyIdInfo': {'id': 'DK081607-01A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Small group', 'description': '10-member groups', 'interventionNames': ['Behavioral: behavioral weight loss program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Large group', 'description': '30-member groups', 'interventionNames': ['Behavioral: behavioral weight loss program']}], 'interventions': [{'name': 'behavioral weight loss program', 'type': 'BEHAVIORAL', 'description': 'weekly, group-based lifestyle weight loss program', 'armGroupLabels': ['Large group', 'Small group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}