Reducing the Weight of Overweight Schizophrenia Patients

August 20, 2018 updated by: Rohan Ganguli, University of Pittsburgh

A Clinical Trial Of Weight Reduction in Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Phase 1 participants who will receive behavioral training for 14 weeks
Behavioral: Behavioral training
The behavioral training will teach participants ways to control their diet and increase their physical activity.
Active Comparator: 2
Phase 1 participants who will receive social skills training for 14 weeks
Behavioral: Social skills training
The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
Experimental: 3
Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2
Behavioral: Behavioral training
The behavioral training will teach participants ways to control their diet and increase their physical activity.
Experimental: 4
Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2
Behavioral: Behavioral training booster sessions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight reduction
Time Frame: Measured at Week 14 and Month 24
Measured at Week 14 and Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight maintenance
Time Frame: Measured at Week 14 and Month 24
Measured at Week 14 and Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Rohan Ganguli, MD, Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH066068 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAP (NIMH/DSIR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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