Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.
Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.
Participants will:
Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.
详细描述
Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.
Objective
The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, 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
- •Body Mass Index > 25kg/m2
排除标准
- 未提供
研究组 & 干预措施
Intervention group
lifestyle intervention including information about ketosis level
干预措施: self-monitoring of breath acetone (Other)
Intervention group
lifestyle intervention including information about ketosis level
干预措施: lifestyle-intervention via LIM-App (Other)
control group
lifestyle intervention without information about ketosis level
干预措施: lifestyle-intervention via LIM-App (Other)
结局指标
主要结局
body weight
时间窗: 3 months
body weight in kg
次要结局
- body weight(12 months)