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

NCT ID: NCT01032369

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity Learning Disability

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CBT

with behavioral intervention-CBT.

Group Type EXPERIMENTAL

Nutritional intervention, physical activity and behavioral treatment

Intervention Type OTHER

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

Group Type OTHER

Nutritional intervention and physical activity

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nachum Vaisman, Prof'

Role: CONTACT

Phone: 009-972-3-6974807

Email: [email protected]

Facility Contacts

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Nachum Vaisman, Prof'

Role: primary

Other Identifiers

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TASMC-09-NV-587-CTIL

Identifier Type: -

Identifier Source: org_study_id