Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01032369
Status:
UNKNOWN
Last Update Posted:
2009-12-15
First Post:
2009-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'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': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-14', 'studyFirstSubmitDate': '2009-12-13', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity).', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community'], 'conditions': ['Overweight', 'Obesity', 'Learning Disability']}, 'descriptionModule': {'briefSummary': 'In this randomized case control study we will evaluate the additive effect of psychological intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program composed of physical activity intervention and nutritional programme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community\n* Subjects who sign an informed consent\n\nExclusion Criteria:\n\n* Subjects with out over-weight or obese subjects with out learning disability subjects who have no completed "Nitzan Onim" two-year training program and live in housing within the community'}, 'identificationModule': {'nctId': 'NCT01032369', 'briefTitle': 'The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Additive Effect of Cognitive Behavioral Treatment - CBT to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities', 'orgStudyIdInfo': {'id': 'TASMC-09-NV-587-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT', 'description': 'with behavioral intervention-CBT.', 'interventionNames': ['Other: Nutritional intervention, physical activity and behavioral treatment']}, {'type': 'OTHER', 'label': 'Without CBT', 'description': 'Without behavioral intervention-CBT', 'interventionNames': ['Other: Nutritional intervention and physical activity']}], 'interventions': [{'name': 'Nutritional intervention and physical activity', 'type': 'OTHER', 'description': "Nutritional intervention:\n\nSubjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up.\n\nPhysical activity:\n\nAll participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking).", 'armGroupLabels': ['Without CBT']}, {'name': 'Nutritional intervention, physical activity and behavioral treatment', 'type': 'OTHER', 'description': 'Nutritional intervention:\n\nSubjects will be asked to attend weekly nutritional group\'s sessions and individual meetings with the dietician for nutritional treatment and follow up.\n\nPhysical activity:\n\nAll participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking).\n\nBehavioral treatment:\n\nThis group will undergo behavioral treatment focusing on self control techniques using the CBT technique (cognitive behavioral therapy) which will be conducted by a clinical psychologist from "ONIM" in weekly group sessions.', 'armGroupLabels': ['CBT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '00-972-3-6974807'}, {'name': "Nachum Vaisman, Prof'", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '009-972-3-6974807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}}}}