Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00537758
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2007-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment for Obesity and Binge Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge Eating'}, {'measure': 'BMI'}]}, 'conditionsModule': {'keywords': ['binge eating disorder', 'cognitive behavior therapy', 'combination therapy', 'obesity', 'weight loss', 'body weight', 'clinical trial', 'dietary restriction', 'overeating', 'weight control'], 'conditions': ['Binge Eating Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '39247962', 'type': 'DERIVED', 'citation': 'Grilo CM, Pittman B. Exploring Dietary Restraint as a Mediator of Behavioral and Cognitive-Behavioral Treatments on Outcomes for Patients With Binge-Eating Disorder With Obesity. Int J Eat Disord. 2024 Dec;57(12):2475-2481. doi: 10.1002/eat.24288. Epub 2024 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Binge Eating\n* Overweight\n\nExclusion Criteria:\n\n* Pregnancy\n* Current cardiac disease\n* Serious neurologic illnesses'}, 'identificationModule': {'nctId': 'NCT00537758', 'briefTitle': 'Treatment for Obesity and Binge Eating Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Treatment for Obesity and Binge Eating Disorder', 'orgStudyIdInfo': {'id': '0204015334'}, 'secondaryIdInfos': [{'id': 'R01DK049587', 'link': 'https://reporter.nih.gov/quickSearch/R01DK049587', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Cognitive Behavior Therapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Behavioral Weight Loss Treatment', 'interventionNames': ['Behavioral: Behavioral Weight Loss Treatment']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'CBT + BWL', 'interventionNames': ['Behavioral: CBT and BWL']}], 'interventions': [{'name': 'Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}, {'name': 'CBT and BWL', 'type': 'BEHAVIORAL', 'armGroupLabels': ['3']}, {'name': 'Behavioral Weight Loss Treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Psychiatric Research at Congress Place', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Carlos M. Grilo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}]}}}