Schizophrenic Disorders Clinical Trial
Official title:
The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.
The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.
Status | Completed |
Enrollment | 133 |
Est. completion date | December 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - A diagnosis of serious mental illness, - Age 18 - 65 - BMI > 25 - Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months). Exclusion Criteria: - Current or history of eating disorder - Pregnant or breast feeding - Uncontrolled HTN - Severe coronary artery disease - Severe valvular disease - Uncontrolled diabetes - Sustained arrhythmia - Insulin using severe physical limitations - Severe Lung Disorders - Diagnosis of MR or dementia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The reduction of weight and Body Mass Index (BMI) | Week 12, Week 24, 1 Year from Baseline Visit | No | |
Secondary | Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity | Baseline, 12 Weeks, 24 weeks, 1 year | No |
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