NCT06745362

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

December 17, 2024

Last Update Submit

June 25, 2025

Conditions

Overweight and Obese Volunteers

Keywords

lifestyle interventionweight reductionketosis

Outcome Measures

Primary Outcomes (1)

  • body weight

    body weight in kg

    3 months

Secondary Outcomes (1)

  • body weight

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

lifestyle intervention including information about ketosis level

Other: self-monitoring of breath acetoneOther: lifestyle-intervention via LIM-App

control group

ACTIVE COMPARATOR

lifestyle intervention without information about ketosis level

Other: lifestyle-intervention via LIM-App

Interventions

self-monitoring of breath acetoneOTHER

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

Intervention group
lifestyle-intervention via LIM-AppOTHER

Participants are offered a lifestyle intervention via LIM-App.

Intervention groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index \> 25kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West German Center of Diabetes and Health

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

OverweightWeight LossKetosis

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesAcidosisAcid-Base ImbalanceMetabolic Diseases

Central Study Contacts

Stephan Martin

CONTACT

049-2115660360stephan.martin@uni-duesseldorf.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

upon request

Locations

DE(1)