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Evaluating the Effectiveness of a Weight Loss Program for Overweight and Obese People With Schizophrenia
This study is ongoing, but not recruiting participants.
Study NCT00177905   Information provided by National Institute of Mental Health (NIMH)
First Received: September 13, 2005   Last Updated: September 19, 2008   History of Changes

September 13, 2005
September 19, 2008
May 2004
April 2009   (final data collection date for primary outcome measure)
  • Weight loss [ Time Frame: Measured at Weeks 7 and 14 ] [ Designated as safety issue: No ]
  • Long term maintenance of weight loss [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]
  • Weight Loss at week 7 and week 14.
  • Long Term Maintenance of Weight Loss 12 and 24 months
Complete list of historical versions of study NCT00177905 on ClinicalTrials.gov Archive Site
  • Blood pressure and cholesterol [ Time Frame: Measured at pre-treatment, Week 14, and Months 12 and 24 ] [ Designated as safety issue: Yes ]
  • Graded Exercise Tolerance Test [ Time Frame: Measured at pre-treatment and Week 14 ] [ Designated as safety issue: No ]
  • BP,Fasting glucose,serum lipids:Baseline, week 14 Phase I.
  • BP,Fasting glucose, serum lipids:Baseline,12,24month Ph II.
  • Graded Exercise Test Baseline, Week 14.
 
Evaluating the Effectiveness of a Weight Loss Program for Overweight and Obese People With Schizophrenia
A Clinical Trial of Weight Reduction in Schizophrenia

This study will evaluate the effectiveness of a behavioral weight loss program for overweight and obese people with schizophrenia.

Schizophrenia is a life-long brain disorder affecting 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. Because of medications, lifestyle, or diet, people with schizophrenia are more at risk for being overweight than others. Excess weight and obesity continue to present ongoing challenges when managing the care of people with schizophrenia. Weight gain often leads to other chronic conditions, such as diabetes or heart disease, which can affect how regularly medications are taken. Behavioral treatment plans for weight reduction are a practical option for people with schizophrenia. Therefore, this study will evaluate the effectiveness of a weight loss treatment program for overweight and obese people with schizophrenia.

Participation in this open-label study will last between 4 and 28 months. Participants will be randomly assigned to one of the following three groups:

  • Group 1 participants will receive behavioral weight loss treatment to learn ways to control urges to overeat and snack, limit food intake, develop good eating habits, and make changes in daily physical activity. Before starting treatment, participants may complete a motivational interview session aimed at strengthening their commitment to losing weight.
  • Group 2 participants will receive social skills training. Topics discussed may include communication, assertiveness, conflict management, dating, medication management, and vocational skills.
  • Group 3 participants will receive routine clinical care. They will meet with a research staff member once a month to record their weight.

Group 1 and 2 participants will attend 20 group sessions over a period of 14 weeks. Sessions will last 1 hour and will occur twice a week for the first 6 weeks and once a week for the remaining 8 weeks. All participants in this study will have an additional study visit, during which a psychiatric assessment will be conducted. After 16 weeks, Groups 2 and 3 will have the option of receiving the behavioral weight loss treatment.

Group 1 participants who lose at least 3 percent of their initial body weight will be randomly assigned to receive either booster treatments or routine clinical care for 2 years. Participants receiving booster treatments will attend one session every 2 weeks during which they will continue to learn behavior techniques for weight reduction and receive ongoing encouragement to maintain their weight loss efforts. Participants assigned to receive routine clinical care will attend study visits at 12 and 24 months. These visits will include various measurements and questions regarding weight, blood pressure, diet, self esteem, mood, and symptoms of schizophrenia. At the end of the study, all participants will undergo blood collection to test for signs of diabetes.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Schizophrenia
  • Behavioral: Behavioral weight loss treatment program
  • Behavioral: Social skills training program
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
300
May 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Body mass index (BMI) greater than 27kg/m2 at study entry
  • Expressed a desire to lose weight
  • Currently being treated with at least one antipsychotic medication
  • A PANSS score below 90 at study entry
  • No psychiatric hospitalization within 1 month of study entry
  • Stable medication dosage regimen for at least 1 month before study entry
  • Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

  • Moderate mental retardation
  • Currently enrolled in a weight management program
  • Currently being treated with a medication for weight reduction
  • Unstable or active cardiovascular illness, active or end-stage kidney disease, unstable thyroid disease, etc.
  • Pregnant or breastfeeding
Both
14 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177905
Rohan Ganguli, MD, University of Pittsburgh School of Medicine
R01 MH066068, DSIR 83-ATAP
National Institute of Mental Health (NIMH)
 
Principal Investigator: Rohan Ganguli, MD Univeristy of Pittsburgh
National Institute of Mental Health (NIMH)
September 2008

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