NCT06745362

Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: West German Center of Diabetes and Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obese Volunteers

Interventions

Type	Name	Description
OTHER	self-monitoring of breath acetone	Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
OTHER	lifestyle-intervention via LIM-App	Participants are offered a lifestyle intervention via LIM-App.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-12-20
• Last updated: 2025-06-29

Locations

1 site across 1 country: Germany