Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Change in Weight Loss in Kilograms (kg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Weight Loss in Kilograms (kg)
时间窗: 6 and 18 months
Change is from baseline to 6 months and baseline to 18 months
次要结局
- 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)