Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-01 @ 7:16 AM
Study NCT ID:
NCT03855566
Status:
TERMINATED
Last Update Posted:
2023-07-18
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-05', 'releaseDate': '2024-11-11'}], 'estimatedResultsFirstSubmitDate': '2024-11-11'}}, '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': 'D050154', 'term': 'Adiposity'}], 'ancestors': [{'id': 'D050218', 'term': 'Body Fat Distribution'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'The study was disrupted by and results confounded by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Changes', 'timeFrame': '0, 6 and 12 months', 'description': 'Weight loss at 0, 6 and 12 months'}, {'measure': 'Retention', 'timeFrame': '12 months', 'description': 'Number of enrolled participants who complete the program'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The Telenutrition Center will use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Framework to assess the implementation of an evidence-based, intensive behavior therapy (IBT) for obesity intervention (with a motivational interviewing \\[MI\\] framework) based on the Centers for Medicaid and Medicare Services (CMS) IBT for obesity benefit. The intervention will be examined under real-world conditions with technology supplementation to address obesity and related chronic disease among young adult (18-50 years of age) African Americans across the state. The intervention contact will model the CMS IBT for obesity benefit according to the patient contact schedule (of weekly visits in the first month, biweekly in months 2-7, and once a month per months 8-12) and include nutrition, stage of change and other physical and psychosocial assessments. Program delivery will be assisted by the "Bridge2U" web and mobile platform and supported in both clinic and community settings. The proposed project will shed new light on how IBT for obesity (and similar) models may be amended to facilitate the provision of health care resources in areas with limited to no resources, such as the state of Mississippi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\>/=28\n* 25 to 50 years of age\n* history or risk of preventable co-morbidities (ie. diabetes, hypertension, and/or dyslipidemia)\n\nExclusion Criteria:\n\n* Body mass index \\<28\n* \\<25 years of age\n* \\>50 years of age\n* no history or risk of preventable obesity comorbidities\n* Any disease diagnosis (ie. cancer) where weight loss is contraindicated'}, 'identificationModule': {'nctId': 'NCT03855566', 'briefTitle': 'Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Mississippi'}, 'officialTitle': 'Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity Among Young to Middle Aged African American Adults in Mississippi', 'orgStudyIdInfo': {'id': 'P20GM103476', 'link': 'https://reporter.nih.gov/quickSearch/P20GM103476', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Enrolled participants will receive the intervention.', 'interventionNames': ['Behavioral: Intensive behavioral therapy for obesity']}], 'interventions': [{'name': 'Intensive behavioral therapy for obesity', 'type': 'BEHAVIORAL', 'description': 'Approximately 24, 20 minute sessions over 12 months focused on diet and physical activity behavior change goals to promote weight loss. Framework includes health belief model, transtheoretical model and motivational interviewing.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39406-0001', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The University of Southern Mississippi', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Mississippi', 'class': 'OTHER'}, 'collaborators': [{'name': "My Brother's Keeper", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-11', 'type': 'RELEASE'}, {'date': '2024-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Southern Mississippi'}}}}