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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06745362

Acronym

WeR-LIM-SMBA

Enrollment

Registered

2024-12-20

Start date

2025-01-01

Completion date

2027-12-31

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obese Volunteers

Keywords

lifestyle intervention, weight reduction, ketosis

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.

Interventions

OTHERself-monitoring of breath acetone

Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.

OTHERlifestyle-intervention via LIM-App

Participants are offered a lifestyle intervention via LIM-App.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Body Mass Index \> 25kg/m2

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
body weight	3 months	body weight in kg

Secondary

Measure	Time frame	Description
body weight	12 months	body weight in kg

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026