Weight Reduction With the Low-Insulin-Method
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Low-Insulin-MethodBehavioral: Telemedical coaching
- Registration Number
- NCT05933759
- Lead Sponsor
- West German Center of Diabetes and Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Body Mass Index 25 kg/m2
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Low-Insulin-Method Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps. Intervention group Telemedical coaching Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching. Intervention group Low-Insulin-Method Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.
- Primary Outcome Measures
Name Time Method Weight change in kg 12 weeks Estimated treatment difference
- Secondary Outcome Measures
Name Time Method HbA1c in % 12 weeks Estimated treatment difference
waist circumference in cm 12 weeks Estimated treatment difference
depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale 12 weeks Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome
insulin in µU/ml 12 weeks Estimated treatment difference
body mass index in kg/m2 12 weeks Estimated treatment difference
lean body mass in kg 12 weeks Estimated treatment difference
muscle mass in kg 12 weeks Estimated treatment difference
fasting blood glucose in mg/dl 12 weeks Estimated treatment difference
food frequency (German version of the food frequency questionnaire) in units on a scale 12 weeks Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
quality of life (short form questionnaire) in units on a scale 12 weeks Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
LDL cholesterol in mg/dl 12 weeks Estimated treatment difference
triglycerides in mg/dl 12 weeks Estimated treatment difference
energy expenditure in kcal 12 weeks Estimated treatment difference
eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale 12 weeks Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
hip circumference in cm 12 weeks Estimated treatment difference
fat mass in kg 12 weeks Estimated treatment difference
blood pressure in mmHg 12 weeks Estimated treatment difference
physical activity in min/day 12 weeks Estimated treatment difference
physical activity in steps/day 12 weeks Estimated treatment difference
total cholesterol in mg/dl 12 weeks Estimated treatment difference
HDL cholesterol in mg/dl 12 weeks Estimated treatment difference
Trial Locations
- Locations (1)
West German Centre of Diabetes and Health
🇩🇪Düsseldorf, Germany