Overweight and Obese VolunteersWeR-LIM-SMBANCT06745362
Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
A study testing self-monitoring of breath acetone and lifestyle-intervention via LIM-App in people with Overweight and Obese Volunteers, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obese Volunteers
- What is being tested?
- self-monitoring of breath acetone and lifestyle-intervention via LIM-App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index > 25kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- self-monitoring of breath acetone, lifestyle-intervention via LIM-App
- Keywords
- lifestyle intervention, weight reduction, ketosis
- Medical subject headings
- Overweight, Weight Loss, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoring of breath acetoneOther
Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
lifestyle-intervention via LIM-AppOther
Participants are offered a lifestyle intervention via LIM-App.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | lifestyle intervention including information about ketosis level Receives: Other: self-monitoring of breath acetone; Other: lifestyle-intervention via LIM-App |
| control group | Active comparator | lifestyle intervention without information about ketosis level Receives: Other: lifestyle-intervention via LIM-App |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in kg
Measured: 3 months
Secondary outcomes (1)
body weight
body weight in kg
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745362
- Sponsor's protocol ID
- 20241217
- Acronym
- WeR-LIM-SMBA
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request