Reducing the Weight of Overweight Schizophrenia Patients

Study Overview
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Brief Summary
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This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

Detailed Description
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Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population. This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.

Official Title
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A Clinical Trial Of Weight Reduction in Schizophrenia

Conditions
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Schizophrenia, Obesity

Intervention / Treatment
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* Behavioral: Behavioral training
* Behavioral: Social skills training
* Behavioral: Behavioral training booster sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Body mass index (BMI) greater than 27 Stable on antipsychotic drug regimen for at least 1 month prior to study entry Parent or guardian willing to provide informed consent, if applicable Positive and negative syndrome scale score less than 90 Willing to use acceptable methods of contraception during the study Exclusion Criteria: Medical contraindication for participating in a weight reduction/exercise program Mental retardation Current enrollment in another weight management program Current use of weight reduction medication Unstable cardiovascular or thyroid disease Active or end-stage renal disease Psychiatric hospitalization within 1 month prior to study entry Current use of more than one anti-psychotic medication Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Phase 1 participants who will receive behavioral training for 14 weeks | Behavioral: Behavioral training<br>* The behavioral training will teach participants ways to control their diet and increase their physical activity.<br>|
| Active Comparator: 2<br>Phase 1 participants who will receive social skills training for 14 weeks | Behavioral: Social skills training<br>* The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.<br>|
| Experimental: 3<br>Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2 | Behavioral: Behavioral training<br>* The behavioral training will teach participants ways to control their diet and increase their physical activity.<br>|
| Experimental: 4<br>Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2 | Behavioral: Behavioral training booster sessions<br>* During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight reduction |  | Measured at Week 14 and Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight maintenance |  | Measured at Week 14 and Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss