Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
NCT06816147

HealthyW8_60+ Pilot

Led by Luxembourg Institute of Health · Updated on 2025-12-12

30

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

Sponsors

L

Luxembourg Institute of Health

Lead Sponsor

E

European Commission

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HealthyW8_60+ Pilot

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 60 years or older
  • Male or female participants from the general free-living population
  • Residing in Luxembourg
  • Having a body mass index (BMI) between 18.5 and 30 kg/m8
  • Owning a smartphone
Not Eligible

You will not qualify if you...

  • Having known chronic diseases that prevent participation, such as cancer or Parkinson's
  • Having cognitive diseases like Alzheimer's or inability to live independently
  • Following a strict diet prescribed by themselves or a physician
  • Being part of special groups such as prisoners, mentally disabled individuals, or those unable to give voluntary informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinical and Epidemiological Investigation Center CIEC- LCTR

Luxembourg, Luxembourg, L-1445

Actively Recruiting

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Research Team

T

Torsten Bohn PhD, Adjunct Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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