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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 because the information has not been verified recently.
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
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
History of Changes
  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:

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

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
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
 Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015