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Reducing the Weight of Overweight Schizophrenia Patients

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Reducing the Weight of Overweight Schizophrenia Patients
Official Title  A Clinical Trial Of Weight Reduction in Schizophrenia
Brief Summary

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

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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Weight reduction [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Weight maintenance [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]
Condition  Schizophrenia
Obesity
Intervention  Behavioral: Behavioral training
Behavioral: Social skills training
Behavioral: Behavioral training booster sessions
MEDLINE PMIDs 15705006,   11356587,   10548138
Links Click here for more information about the Schizophrenia and Wellness Research Program This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  300
Start Date  May 2004
Completion Date May 2009
Eligibility 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
Gender Both
Ages 14 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00158366
Organization ID R01 MH66068
Secondary IDs †† DSIR 83-ATAP
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Jaspreet Brar, MBBS, MPH     Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center    
Principal Investigator:     Rohan Ganguli, MD     Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  September 7, 2005
Last Updated Date March 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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