Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Increase in maximum oxygen uptake
研究概览
简要总结
We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).
详细描述
The intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. They have 7 meetings in groups of 10 persons over 3 months. The controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year.
We tell all that small changes are making big differenses (in weight and the chanse of getting ill). Everyone is told that lack of aktivity is the main reason to obesity. Lack of activity also influense in whar you eat. herefore is activity in the "center".
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes risk score above 9 points.
排除标准
- •Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.
结局指标
主要结局
Increase in maximum oxygen uptake
Change in foodintake
Change in self-reported activity
Weigtreduction
次要结局
- Quality of life