Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: self-monitoring of breath acetone, lifestyle-intervention via LIM-App.
- Who it may be relevant to
- Registry conditions: Overweight and Obese Volunteers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- body weight [Time frame: 3 months]
Secondary outcome measures (1)
- body weight [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Body Mass Index > 25kg/m2
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- West German Center of Diabetes and Health — Düsseldorf
Identifiers
NCT: NCT06745362 · 20241217