Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
NCT ID: NCT06745362
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention group
lifestyle intervention including information about ketosis level
self-monitoring of breath acetone
Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
lifestyle-intervention via LIM-App
Participants are offered a lifestyle intervention via LIM-App.
control group
lifestyle intervention without information about ketosis level
lifestyle-intervention via LIM-App
Participants are offered a lifestyle intervention via LIM-App.
Interventions
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self-monitoring of breath acetone
Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
lifestyle-intervention via LIM-App
Participants are offered a lifestyle intervention via LIM-App.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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West German Center of Diabetes and Health
OTHER
Responsible Party
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Locations
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West German Center of Diabetes and Health
Düsseldorf, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20241217
Identifier Type: -
Identifier Source: org_study_id
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