Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 742
- 试验地点
- 25
- 主要终点
- change in body weight 10 weeks post-intervention
研究概览
简要总结
Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits.
The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders.
The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •18 years of age or older
- •living in sheltered housing
- •diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
排除标准
- 未提供
结局指标
主要结局
change in body weight 10 weeks post-intervention
时间窗: after 10 weeks
The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
change in body weight 26 weeks post-intervention
时间窗: after 26 weeks
The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
次要结局
- Psychiatric symptom severity, 26 weeks post-intervention(After 26 weeks)
- Levels of physical activity, 26 weeks post-intervention(After 26 weeks)
- Waist circumference, 10 weeks post-intervention(After 10 weeks)
- Waist circumference, 26 weeks post-intervention(After 26 weeks)
- Body Mass Index 10 weeks post-intervention(after 10 weeks)
- Body Mass Index, 26 weeks post-intervention(after 26 weeks)
- Quality of Life, 10 weeks post-intervention(After 10 weeks)
- Quality of Life, 26 weeks post-intervention(After 26 weeks)
- Levels of physical activity, 10 weeks post-intervention(After 10 weeks)
- Eating habits, 10 weeks post-intervention(After 10 weeks)
- Eating habits, 26 weeks post-intervention(After 26 weeks)
- Psychiatric symptom severity, 10 weeks post-intervention(After 10 weeks)