| NCT ID | NCT06816147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luxembourg Institute of Health |
| Condition | Obesity Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-11-19 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study will focus on men and women aged ≥60 years for a period of 3 months during which each participant will use the HLRS. The primary purpose is to study whether the HLRS, reflecting a multi-component intervention, is well accepted by the participant, has a decent adherence (i.e., user time of the app). In addition, investigators will study the feasibility of the design, i.e. whether the overall design is well suited to the participants, in order to improve their lifestyle, e.g., dietary habits and PA, among others. Secondary outcomes related to the feasibility approach include dietary habits, PA patterns, and selected plasma and urinary endpoints. This pilot study will be of longitudinal design without a control group. A later trial that is planned for the following year will focus further on biological endpoints and will be randomized. In this present pilot study, investigators aim to assess mainly the user-friendliness of the HLRS, and gather first evidence that the intervention can indeed produce healthier lifestyle patterns. The study's primary objective is to determine whether the developed HLRS can be successfully applied to the target population (men and women aged ≥60 years) and whether they use it frequently during the study and are satisfied with the HLRS. Secondly, investigators will study whether the assessment of endpoints required for the later and separately planned ensuing long-term study can be well assessed within the study and if, despite the limited time of the intervention duration, the intervention will be able to preliminary improve specific markers related to the risk of obesity and associated comorbidities. This will entail anthropometric measures to assess changes in body mass and body fat in addition to the primary and secondary objectives.
Eligibility Criteria
Inclusion Criteria: Individuals aged 60 or older: * both males/females, general free-living population, * residing in Luxembourg, * having normal weight or being overweight, i.e., with a BMI between 18.5 ; 30 kg/m², which is considered a risk factor for developing obesity, * owning a smartphone. Exclusion Criteria: * With known manifest chronic diseases that prohibits participation in the study (e.g., cancer, Parkinson's), * Persons with cognitive diseases (Alzheimer's) or those who are not able to lead an independent life, * Persons following a strict diet (on their own or advised by their physician), * Particular population groups, such as prisoners, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06816147 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Obesity Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06816147 currently recruiting?
Yes, NCT06816147 is actively recruiting participants. Contact the research team at Torsten.Bohn@lih.lu for enrollment information.
Where is the NCT06816147 trial being conducted?
This trial is being conducted at Luxembourg, Luxembourg.
Who is sponsoring the NCT06816147 clinical trial?
NCT06816147 is sponsored by Luxembourg Institute of Health. The trial plans to enroll 30 participants.
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