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Pittsburgh, Pennsylvania 15213


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00177905


Primary Contact:

Principal Investigator
Rohan Ganguli, MD
Univeristy of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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