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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.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00177905
  Purpose

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


Condition Intervention
Schizophrenia
Behavioral: Behavioral weight loss treatment program
Behavioral: Social skills training program

MedlinePlus related topics: Obesity Obesity in Children Schizophrenia Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Clinical Trial of Weight Reduction in Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2004
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Behavioral: Behavioral weight loss treatment program
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. Participants will attend 20 group sessions over a period of 14 weeks.
B: Active Comparator Behavioral: Social skills training program
Participants will receive social skills training. Topics discussed may include communication, assertiveness, conflict management, dating, medication management, and vocational skills. Participants will attend 20 group sessions over a period of 14 weeks.
C: No Intervention

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177905

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

Click here for other studies being conducted by this researcher  This link exits the ClinicalTrials.gov site

Responsible Party: University of Pittsburgh School of Medicine ( Rohan Ganguli, MD )
Study ID Numbers: R01 MH066068, DSIR 83-ATAP
Study First Received: September 13, 2005
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00177905  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizo-affective Disorder
Obesity
Cardiovascular Disease
Behavioral Weight Loss Intervention
Self-esteem
Compliance

Study placed in the following topic categories:
Schizophrenia
Body Weight
Obesity
Mental Disorders
Weight Loss
Mood Disorders
Psychotic Disorders
Overweight
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009