Lifestyle Modification for Weight Loss in Schizophrenia

Yale University149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

149

Conditions

Obesity Schizophrenia Schizoaffective Disorder

Interventions

Nutritional Lifestyle Modification GroupBEHAVIORAL

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

Usual CareOTHER

Care as usual

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

The primary outcome measure is change in body weight from baseline.

Time frame: 16 weeks, 6 month follow-up

Secondary Outcomes

Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)

Time frame: 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)

Time frame: 16 weeks, 6 month follow-up

Data from ClinicalTrials.gov

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