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Reducing the Weight of Overweight Schizophrenia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00158366
First received: September 7, 2005
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Schizophrenia
Obesity
Behavioral: Behavioral training
Behavioral: Social skills training
Behavioral: Behavioral training booster sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial Of Weight Reduction in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight maintenance [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158366

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Rohan Ganguli, MD Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00158366     History of Changes
Obsolete Identifiers: NCT00177905
Other Study ID Numbers: R01 MH66068, R01MH066068, DSIR 83-ATAP
Study First Received: September 7, 2005
Last Updated: January 11, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Weight Loss

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2014