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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
42
Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
Participants are offered a lifestyle intervention via LIM-App.
West German Center of Diabetes and Health
Düsseldorf, Germany
body weight
body weight in kg
Time frame: 3 months
body weight
body weight in kg
Time frame: 12 months
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