Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Weight change in kg
研究概览
简要总结
Background: Overweight and obesity affect health, quality of life and ability to work. 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, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 weeks.
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
- Double (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
- 是
入选标准
- •Body Mass Index 25 kg/m2
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
干预措施: Telemedical coaching (Behavioral)
Intervention group
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
干预措施: Low-Insulin-Method (Behavioral)
Control group
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.
干预措施: Low-Insulin-Method (Behavioral)
结局指标
主要结局
Weight change in kg
时间窗: 12 weeks
Estimated treatment difference
次要结局
- lean body mass in kg(12 weeks)
- HbA1c in %(12 weeks)
- waist circumference in cm(12 weeks)
- depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale(12 weeks)
- insulin in µU/ml(12 weeks)
- body mass index in kg/m2(12 weeks)
- muscle mass in kg(12 weeks)
- fasting blood glucose in mg/dl(12 weeks)
- food frequency (German version of the food frequency questionnaire) in units on a scale(12 weeks)
- quality of life (short form questionnaire) in units on a scale(12 weeks)
- LDL cholesterol in mg/dl(12 weeks)
- triglycerides in mg/dl(12 weeks)
- energy expenditure in kcal(12 weeks)
- eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale(12 weeks)
- hip circumference in cm(12 weeks)
- fat mass in kg(12 weeks)
- blood pressure in mmHg(12 weeks)
- physical activity in min/day(12 weeks)
- physical activity in steps/day(12 weeks)
- total cholesterol in mg/dl(12 weeks)
- HDL cholesterol in mg/dl(12 weeks)