Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- weight result
研究概览
简要总结
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.
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
- 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
- •BMI 35 kg/m2 or more
- •Age 18-65 years
排除标准
- •Type 1 diabetes
- •Major alcohol problem
- •Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years
研究组 & 干预措施
2
Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life.
干预措施: weight loss programme (Behavioral)
1
Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later.
干预措施: weight loss programme with maintenance programme (Behavioral)
结局指标
主要结局
weight result
时间窗: 2 years after weight loss phase
次要结局
- quality of life and eating behavior(2 years after active weight loss)