NCT06816147Recruiting
HealthyW8_60+ Pilot
Empowering Healthy Lifestyle Behavior Through Personalized Intervention Portfolios to Prevent and Control Obesity in the Elderly
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 19 Nov 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Luxembourg Institute of Health
- Diseases
- Obesity
- NCT number
- NCT06816147
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 19 Nov 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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,
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical and Epidemiological Investigation Center CIEC- LCTR Coordinator of this site? Confirm its status | Luxembourg | Luxembourg | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.