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| Descriptive Information Fields | |||||
| Brief Title † | Evaluating the Effectiveness of a Weight Loss Program for Overweight and Obese People With Schizophrenia | ||||
| Official Title † | A Clinical Trial of Weight Reduction in Schizophrenia | ||||
| Brief Summary | This study will evaluate the effectiveness of a behavioral weight loss program for overweight and obese people with schizophrenia. |
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| 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 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Weight loss [ Time Frame: Measured at Weeks 7 and 14 ] Long term maintenance of weight loss [ Time Frame: Measured at Months 12 and 24 ] |
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| Secondary Outcome Measure † | Blood pressure and cholesterol [ Time Frame: Measured at pre-treatment, Week 14, and Months 12 and 24 ] Graded Exercise Tolerance Test [ Time Frame: Measured at pre-treatment and Week 14 ] |
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| Condition † | Schizophrenia | ||||
| Intervention † | Behavioral: Behavioral weight loss treatment program Behavioral: Social skills training program |
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| MEDLINE PMIDs | |||||
| Links | Click here for other studies being conducted by this researcher ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 300 | ||||
| Start Date † | May 2004 | ||||
| Completion Date | May 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00177905 | ||||
| Organization ID | R01 MH066068 | ||||
| Secondary IDs †† | DSIR 83-ATAP | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | March 6, 2008 | ||||