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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT01032369 History of Changes
Other Study ID Numbers:	TASMC-09-NV-587-CTIL
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:

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