Clinical trial

HealthyW8_60+ Pilot

Recruiting now · Not applicable · 1 countries · Registry ID NCT06816147

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age60 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionObesity Prevention

Full registry 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.

Treatments and study arms

Investigators will evaluate the acceptance and adherence to a healthy lifestyle recommender solution (HLRS), a digital app, among participants

Other

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.

Primary outcomes

Health Lifestyle Recommender System adherence time3 month intervention period from baseline (Day 1) to final measurement (Day 90)

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.

Health Lifestyle Recommender system user experience3 month intervention period from baseline (Day 1) to final measurement (Day 90)

User experience corresponds to the points achieved in the User Experience Questionnaire (UEQ+, 26 items). This questionnaire analyses the attractiveness, perspicuity, efficiency, dependability, stimulation and novelty of a new product (in this case HLRS). The UEQ contains 26 items. Each item is evaluated with a 7-point Likert scale (-3 to 3 points). Then the product is classified as excellent (3 points) or bad (-3 points).

Study locations

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Clinical and Epidemiological Investigation Center CIEC- LCTR🌐 Luxembourg, Luxembourg

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Ali ZnatiContact

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