Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01854320
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2013-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline - 2-year follow-up'}]}, 'conditionsModule': {'conditions': ['Acceptance-based Treatment', 'Standard Behavioral Treatment']}, 'referencesModule': {'references': [{'pmid': '40705619', 'type': 'DERIVED', 'citation': 'Chabria R, Hagerman CJ, Crane N, Ehmann M, Knudsen FM, Brown KL, Forman E, Butryn ML. Racial disparities in the efficacy of traditional versus acceptance-based behavioral weight loss. Health Psychol. 2025 Jul 24:10.1037/hea0001537. doi: 10.1037/hea0001537. Online ahead of print.'}, {'pmid': '31916827', 'type': 'DERIVED', 'citation': 'Crochiere RJ, Kerrigan SG, Lampe EW, Manasse SM, Crosby RD, Butryn ML, Forman EM. Is physical activity a risk or protective factor for subsequent dietary lapses among behavioral weight loss participants? Health Psychol. 2020 Mar;39(3):240-244. doi: 10.1037/hea0000839. Epub 2020 Jan 9.'}, {'pmid': '30951589', 'type': 'DERIVED', 'citation': 'Godfrey KM, Schumacher LM, Butryn ML, Forman EM. Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. Ann Behav Med. 2019 Nov 9;53(12):1009-1019. doi: 10.1093/abm/kaz011.'}, {'pmid': '29442440', 'type': 'DERIVED', 'citation': 'Butryn ML, Call CC, Schumacher LM, Kerrigan SG, Forman EM. Time to Peak Weight Loss During Extended Behavioral Treatment. Obesity (Silver Spring). 2018 Apr;26(4):658-664. doi: 10.1002/oby.22127. Epub 2018 Feb 14.'}, {'pmid': '25106049', 'type': 'DERIVED', 'citation': 'Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this project is to determine if an innovative behavioral weight loss program that incorporates new developments from the field of behavior therapy produces superior weight control than standard behavioral treatment. A sample of 200 adults from the community are participating in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 18 and 70\n* Have a BMI between 27-50\n* Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest).\n* Agree to provide permission for the research team to regularly contact your physician throughout the study to share information on changes in your weight.\n* Successfully complete all steps in the enrollment process\n\nExclusion Criteria:\n\n* You have a medical condition or psychiatric condition that may limit your ability to comply with the behavioral recommendations of the program or pose a risk to you during weight loss.\n* You are pregnant or plan to become pregnant in the next three years.\n* Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain.\n* You are participating in or plan to participate in another weight loss program in the next three years.\n* The research team identifies any factors that would render you potentially unable or unlikely to follow the protocol, or unable to benefit from it.'}, 'identificationModule': {'nctId': 'NCT01854320', 'acronym': 'MYH-II', 'briefTitle': 'Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms', 'orgStudyIdInfo': {'id': 'R01DK095069', 'link': 'https://reporter.nih.gov/quickSearch/R01DK095069', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance-based treatment', 'description': 'Behavioral therapy for weight loss focusing on acceptance-based cognitive strategies and techniques.', 'interventionNames': ['Behavioral: Acceptance-based treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard behavioral treatment', 'description': 'Standard behavioral therapy for weight loss, the "gold standard" treatment.', 'interventionNames': ['Behavioral: Standard behavioral treatment']}], 'interventions': [{'name': 'Acceptance-based treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Acceptance-based treatment']}, {'name': 'Standard behavioral treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard behavioral treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Evan Forman', 'investigatorAffiliation': 'Drexel University'}}}}