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HealthyW8_60+ Pilot

Study acronym: HealthyW8
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 12, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 31, 2025 to Nov 19, 2025
    • Collaborators: 2 to 1
    v3
  2. Notable Primary completion date: Sep 30, 2025 to Sep 30, 2026v2 Show 4 more changesShow less
    • Start date: Mar 1, 2025 to Oct 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Study title revised
    • Eligibility criteria expanded, about 3 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06816147
Lead Sponsor Luxembourg Institute of Health
Collaborators: European Commission
Conditions
(from sponsor)
Obesity Prevention
Related terms Obesity, Overweight
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov