Lifestyle Modification for Weight Loss in Schizophrenia

NCT ID: NCT00990925

Last Updated: 2015-11-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.

Detailed Description

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Conditions

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Obesity Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weight Loss Education Group

Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.

Group Type EXPERIMENTAL

Nutritional Lifestyle Modification Group

Intervention Type BEHAVIORAL

Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.

Usual Care

Treatment as usual

Group Type OTHER

Usual Care

Intervention Type OTHER

Care as usual

Interventions

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Nutritional Lifestyle Modification Group

Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.

Intervention Type BEHAVIORAL

Usual Care

Care as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects will be between 18 and 65 years of age.
2. Have a BMI of 28 or greater.
3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.

Exclusion Criteria

1. A history of dementia or mental retardation.
2. Not capable of giving informed consent for participation in this study.
3. Ongoing pregnancy.
4. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Cenk Tek

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cenk Tek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH080048

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0903004806

Identifier Type: -

Identifier Source: org_study_id

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