Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone (WeR-LIM-SMBA)

West German Center of Diabetes and Health

Status: Not yet enrolling

Conditions: Overweight and Obese Volunteers

Treatments: Other: self-monitoring of breath acetone; Other: lifestyle-intervention via LIM-App

Study type: Interventional

Funder types: Other

Identifiers

NCT06745362

20241217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index > 25kg/m2

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Intervention group

Experimental group

Description:

lifestyle intervention including information about ketosis level

Treatment:

Other: lifestyle-intervention via LIM-App

Other: self-monitoring of breath acetone

control group

Active Comparator group

Description:

lifestyle intervention without information about ketosis level

Treatment:

Other: lifestyle-intervention via LIM-App