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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

September 7, 2005
January 11, 2012
May 2004
May 2010   (final data collection date for primary outcome measure)
Weight reduction [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]
Weight reduction
Complete list of historical versions of study NCT00158366 on ClinicalTrials.gov Archive Site
Weight maintenance [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]
Weight maintenance
Not Provided
Not Provided
 
Reducing the Weight of Overweight Schizophrenia Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Obesity
  • Behavioral: Behavioral training
    The behavioral training will teach participants ways to control their diet and increase their physical activity.
  • 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.
  • 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.
  • Experimental: 1
    Phase 1 participants who will receive behavioral training for 14 weeks
    Intervention: Behavioral: Behavioral training
  • Active Comparator: 2
    Phase 1 participants who will receive social skills training for 14 weeks
    Intervention: Behavioral: Social skills training
  • 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
    Intervention: Behavioral: Behavioral training
  • 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
    Intervention: Behavioral: Behavioral training booster sessions

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2012
May 2010   (final data collection date for primary outcome measure)

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
Both
14 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158366
R01 MH66068, R01MH066068, DSIR 83-ATAP
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Rohan Ganguli, MD Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
University of Pittsburgh
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP