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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032369
First Posted: December 15, 2009
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  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
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

ClinicalTrials.gov Identifier: NCT01032369     History of Changes
Other Study ID Numbers: TASMC-09-NV-587-CTIL
First Submitted: December 13, 2009
First Posted: December 15, 2009
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:
Intellectual Disability
Learning Disorders
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders