Weight Reduction with the Low-Insulin-Method - Self Monitoring of Breath Acetone
- Conditions
- Overweight and Obese Volunteers
- Registration Number
- NCT06745362
- Lead Sponsor
- West German Center of Diabetes and Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- Body Mass Index > 25kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method body weight 3 months body weight in kg
- Secondary Outcome Measures
Name Time Method body weight 12 months body weight in kg
Trial Locations
- Locations (1)
West German Center of Diabetes and Health
🇩🇪Düsseldorf, Germany