Reducing the Weight of Overweight Schizophrenia Patients

University of Pittsburgh261 enrolled

Overview

This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population. This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

261

Conditions

Schizophrenia Obesity

Interventions

Behavioral trainingBEHAVIORAL

The behavioral training will teach participants ways to control their diet and increase their physical activity.

Social skills trainingBEHAVIORAL

The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.

Behavioral training booster sessionsBEHAVIORAL

During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of schizophrenia or schizoaffective disorder * Body mass index (BMI) greater than 27 * Stable on antipsychotic drug regimen for at least 1 month prior to study entry * Parent or guardian willing to provide informed consent, if applicable * Positive and negative syndrome scale score less than 90 * Willing to use acceptable methods of contraception during the study Exclusion Criteria: * Medical contraindication for participating in a weight reduction/exercise program * Mental retardation * Current enrollment in another weight management program * Current use of weight reduction medication * Unstable cardiovascular or thyroid disease * Active or end-stage renal disease * Psychiatric hospitalization within 1 month prior to study entry * Current use of more than one anti-psychotic medication * Pregnancy or breastfeeding

Locations (1)

Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Weight reduction

Time frame: Measured at Week 14 and Month 24

Secondary Outcomes

Weight maintenance

Time frame: Measured at Week 14 and Month 24

Data from ClinicalTrials.gov

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