NCT00572247已完成不适用
The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- The reduction of weight and Body Mass Index (BMI)
研究概览
简要总结
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.
详细描述
The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
The reduction of weight and Body Mass Index (BMI)
时间窗: Week 12, Week 24, 1 Year from Baseline Visit
次要结局
- Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity(Baseline, 12 Weeks, 24 weeks, 1 year)
研究者
研究点 (2)
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