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The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities

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ClinicalTrials.gov Identifier: NCT01032369
Recruitment Status : Unknown
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Obesity Learning Disability Other: Nutritional intervention and physical activity Other: Nutritional intervention, physical activity and behavioral treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity). [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT01032369     History of Changes
Other Study ID Numbers: TASMC-09-NV-587-CTIL
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

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:
Overweight
Weight Loss
Intellectual Disability
Learning Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders