Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Johns Hopkins University
- Enrollment
- 291
- Locations
- 1
- Primary Endpoint
- Change in Weight Loss in Kilograms (kg)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
This study will determine whether a behavioral weight loss intervention including dietary counseling and exercise is effective in helping people with serious mental illnesses lose weight.
Detailed Description
The objective of this study is to perform a randomized clinical trial (ACHIEVE) to definitively test the efficacy of an innovative, practical intervention to accomplish weight loss in overweight and obese persons with SMI. This multi-site trial will enroll consumers with SMI who attend ten psychiatric rehabilitation centers in Maryland and randomize participants to the ACHIEVE intervention or control. Intervention participants will receive group and individual weight loss counseling sessions and group physical activity classes. Co-primary outcomes will be change in weight from baseline to 6 and 18 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Weight Loss in Kilograms (kg)
Time Frame: 6 and 18 months
Change is from baseline to 6 months and baseline to 18 months
Secondary Outcomes
- Minutes Cycled During Cycle Ergometry Testing(Baseline, 6 and 18 months)
- Change in Systolic and Diastolic Blood Pressure (mmHg)(Measured at baseline, 6 and 18 months)
- Health Status as Measured by the SF-12(Baseline, 6 and 18 months)
- Change in Waist Circumference in Centimeters (cm)(Measured at baseline, 6 and 18 months)
- Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)(Measured at baseline, 6 and 18 months)
- Framingham Cardiovascular Risk Score(Measured at baseline, 6 and 18 months)
- Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 6 and 18 months)