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Completed

NCT Number: NCT00158366

Reducing the Weight of Overweight Schizophrenia Patients

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

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral training

Behavioral

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

Social Skills Training

Behavioral

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

Behavioral training booster sessions

Behavioral

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.

Primary outcomes

  1. Weight reduction

    Time frame: Measured at Week 14 and Month 24

Secondary outcomes

  1. Weight maintenance

    Time frame: Measured at Week 14 and Month 24

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Clinical Trial Of Weight Reduction in Schizophrenia

Important dates

Study start
2004
Primary completion
2010
Study completion
2018
First posted
Sep 12, 2005
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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