Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 3:05 PM
Study NCT ID:
NCT03680703
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Scalable Internet Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change', 'timeFrame': '3 months', 'description': 'Percent weight loss (in pounds) from baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to conduct a randomized clinical trial examining the feasibility and effectiveness of two guided self-help behavioral weight loss (gshBWL) treatments delivered via the internet for individuals struggling with weight loss one year following bariatric surgery. The two treatments will consist of 1) gshBWL delivered through the internet only (gshBWL-I) and 2) gshBWL delivered via the internet with additional complementary phone sessions (gshBWL-IP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* gastric bypass and sleeve surgery patients from Yale's Bariatric/Gastrointestinal Surgery Program\n* surgery 1-2 years prior\n* \\<60% excess weight loss\n* able to read English proficiently enough to read the patient self-help materials and study assessments\n* available for the duration of the treatment\n* availability of internet and phone to participate in study interventions\n* agree to the study procedures\n\nExclusion Criteria:\n\n* medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)\n* unable to ambulate\n* current medications that influence eating/weight\n* current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment."}, 'identificationModule': {'nctId': 'NCT03680703', 'briefTitle': 'Bariatric Scalable Internet Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery', 'orgStudyIdInfo': {'id': '2000023155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet', 'description': 'Guided self-help behavioral weight loss treatment delivered via the internet', 'interventionNames': ['Behavioral: Guided Self-Help Behavioral Weight Loss']}, {'type': 'EXPERIMENTAL', 'label': 'Internet Plus Phone', 'description': 'Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations', 'interventionNames': ['Behavioral: Guided Self-Help Behavioral Weight Loss']}], 'interventions': [{'name': 'Guided Self-Help Behavioral Weight Loss', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided with patient-focused materials and worksheets that contain all the necessary information, procedures, and techniques of the behavioral weight loss program. For 12 weeks, treatment will be provided over the internet. This therapy focuses on making gradual and modest lifestyle changes with goals of normalizing eating patterns, decreasing caloric intake, building coping skills, and increasing physical activity.', 'armGroupLabels': ['Internet', 'Internet Plus Phone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Department of Psychiatry', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Valentina Ivezaj, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}