HealthyW8_60+ Pilot

NCT ID: NCT06816147

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-19
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

The number of people struggling with overweight and obesity continues to grow in most countries worldwide, despite varied measures trying to limit the further progress of this pandemic. In Luxembourg, at present, about 26% of the adult population is considered as having obesity(BMI>30 kg/m²), and the associated health costs have been estimated at 1.4% of the GDP or about 930 Mio. USD for Luxembourg. Similar numbers are prevalent in other European countries.

The ongoing problem of high obesity rates has resulted in the creation of a pan-European project HealthyW8 (www.healthyw8.eu), funded by the European Union and in which the Luxembourg Institute of Health (LIH) is the coordinator.

The study described in this application is therefore motivated by the project's main objectives, which entails, among other, a total of 22 pilot trials in various European countries to be conducted. This application concerns only the activities planned in Luxembourg.

With the HealthyW8_65+ Pilot project, investigators have focused on population groups at risk of developing obesity, due to undergoing transitions in their lifestyle. Among the populations at risk are older adults as, categorized as having an age of equal to or above 65 years. As emphasized in the literature, older adults constitute a growing fraction of our society, with likely high associated healthcare costs, whose change to a more sedentary lifestyle upon retirement adds an additional risk factor, especially for sarcopenic obesity and related comorbidities, i.e., low muscle mass and consequences.

As innovative solutions to combat the trend toward increasing overweight and obesity in our society are much in need, the present study aims to employ the developed healthy lifestyle recommender solution (HLRS), which is at the center of a digital application for mobile phones. This HLRS intends to address various factors known to constitute main risks for developing obesity, including dietary patterns, physical activity (PA), and psychological/behavioral ones, among other lifestyle factors, such as sleep patterns, while also considering socio-demographic aspects. Our approach addresses several of the shortcomings of existing apps by catering to individuals with low interest in healthy lifestyles and try to motivate them via nudges and gamifications and organized information sessions to participate.

The pilot study will primarily focus on usability and user experience of the HLRS. An accurate assessment of food intake will be ensured through validated semi-quantitative FFQs and user feedback from the HLRS regarding meals that have been consumed. It is important to note, however, that there will be a secondary outcome, i.e. to test the operational feasibility of the study. This includes collecting biological samples, their measuring and shipment to partners outside Luxembourg. This is important, as this pilot study will be followed by a long term study, i.e. employing the same developed HLRS, but then targeting rather metabolic changes.

Conditions

Obesity Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Participant from the general population living in Luxembourg free of manifest diagnosed diseases

The following clinical visits and data collection points will be set up within the study:

1. Enrollment visit: the participant will sign the informed consent, the eligibility of the participant will be evaluated based on anthropometric measures, a urine spot sample, as well as general questionnaire. If found eligible, the participant can continue the study

2. Baseline visit: a number of questionnaires will be filled out by the participant, anthropometric data will be obtained, and a urine and blood sample will be taken, and a stool sample will be provided

3. Intermediate follow-up: this will consist of a phone interview or physical meeting

4. Final visit: a number of questionnaires will be filled anthropometric data, urine, blood and stool will be collected

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Luxembourg Institute of Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical and Epidemiological Investigation Center CIEC- LCTR

Luxembourg, , Luxembourg

Site Status: RECRUITING

Countries

Luxembourg

Central Contacts

Torsten Bohn PhD, Adjunct Associate Professor

Role: CONTACT

Torsten.Bohn@lih.lu

621763805 ext. +352

Facility Contacts

Ali Znati

Role: primary

HW8clinicalteam@lih.lu

352 26970-400

Other Identifiers

101080645

Identifier Type: -

Identifier Source: org_study_id