The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01032369
First received: December 13, 2009
Last updated: December 14, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Overweight Obesity Learning Disability |
Other: Nutritional intervention and physical activity Other: Nutritional intervention, physical activity and behavioral treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | The Additive Effect of Cognitive Behavioral Treatment - CBT to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities |
Resource links provided by NLM:
Genetics Home Reference related topics:
CASK-related intellectual disability
SYNGAP1-related intellectual disability
U.S. FDA Resources
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT
with behavioral intervention-CBT.
|
Other: Nutritional intervention, physical activity and behavioral treatment
Nutritional intervention: Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up. Physical activity: All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking). Behavioral treatment: This 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. |
|
Without CBT
Without behavioral intervention-CBT
|
Other: Nutritional intervention and physical activity
Nutritional intervention: Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up. Physical activity: All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking). |
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Subjects who sign an informed consent
Exclusion Criteria:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032369
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032369
Contacts
| Contact: Nachum Vaisman, Prof' | 009-972-3-6974807 | vaisman@tasmc.health.gov.il |
Locations
| Israel | |
| Tel Aviv Medical Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: Nachum Vaisman, Prof' 00-972-3-6974807 vaisman@tasmc.health.gov.il | |
| Principal Investigator: Nachum Vaisman, Prof' | |
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
| ClinicalTrials.gov Identifier: | NCT01032369 History of Changes |
| Other Study ID Numbers: | TASMC-09-NV-587-CTIL |
| Study First Received: | December 13, 2009 |
| Last Updated: | December 14, 2009 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community |
Additional relevant MeSH terms:
|
Intellectual Disability Overweight Weight Loss Learning Disorders Body Weight Signs and Symptoms Body Weight Changes |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurodevelopmental Disorders Mental Disorders Communication Disorders |
ClinicalTrials.gov processed this record on September 28, 2016