Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00177905 |
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 |
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 |
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 |
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 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.
Ages Eligible for Study: | 14 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Rohan Ganguli, MD | Univeristy of Pittsburgh |
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 |
Schizo-affective Disorder Obesity Cardiovascular Disease |
Behavioral Weight Loss Intervention Self-esteem Compliance |
Schizophrenia Body Weight Obesity Mental Disorders Weight Loss |
Mood Disorders Psychotic Disorders Overweight Schizophrenia and Disorders with Psychotic Features |