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

Primary Purpose

Overweight, Obesity, Learning Disability

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Nutritional intervention and physical activity

Nutritional intervention, physical activity and behavioral treatment

About this trial

This is an interventional health services research trial for Overweight focused on measuring Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CBT

Without CBT

Arm Description

with behavioral intervention-CBT.

Without behavioral intervention-CBT

Outcomes

Primary Outcome Measures

To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity).

Secondary Outcome Measures

Full Information

NCT ID

NCT01032369

First Posted

December 13, 2009

Last Updated

December 14, 2009

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01032369

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Learning Disability

Keywords

Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBT

Arm Type

Experimental

Arm Description

with behavioral intervention-CBT.

Arm Title

Without CBT

Arm Type

Other

Arm Description

Without behavioral intervention-CBT

Intervention Type

Other

Intervention Name(s)

Nutritional intervention and physical activity

Intervention Description

Intervention Type

Other

Intervention Name(s)

Nutritional intervention, physical activity and behavioral treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nachum Vaisman, Prof'

Phone

009-972-3-6974807

vaisman@tasmc.health.gov.il

Facility Information:

Facility Name

Tel Aviv Medical Center

City

Tel Aviv

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nachum Vaisman, Prof'

Phone

00-972-3-6974807

vaisman@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Nachum Vaisman, Prof'

12. IPD Sharing Statement

Learn more about this trial

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

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