HealthyW8_60+ Pilot

ConditionObesity Prevention

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorLuxembourg Institute of Health

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Investigators will evaluate the acceptance and adherence to a healthy lifestyle recommender solution (HLRS), a digital app, among participants
Other intervention
The intervention will include collecting blood, stool, urinary samples as well as measuring anthropometrics and collecting data (socio-demographics, general health, well-being, PA, and eating patterns, among others) via questionnaires completed in part from a mobile application.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Participant from the general population living in Luxembourg free of manifest diagnosed diseasesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Health Lifestyle Recommender System adherence time

Adherence time (daily and weekly usage time in minutes) will be measured by tracking through user log-data, with analysis of any significant changes in usage comparing baseline with final measurement.

Time frame