Lifestyle Modification for Weight Loss in Schizophrenia

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia; Obesity
• Interventions: Behavioral: Nutritional Lifestyle Modification Group; Other: Usual Care

• Registration Number: NCT00990925
• Lead Sponsor: Yale University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Loss Education Group	Nutritional Lifestyle Modification Group	Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Usual Care	Usual Care	Treatment as usual

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is change in body weight from baseline.	16 weeks, 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)	16 weeks, 6 month follow-up
Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)	16 weeks, 6 month follow-up

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States