HealthyW8_60+ Pilot

NCT06816147 | Recruiting

• 1 other identifier: 101080645
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention

Keywords

Obesity; BMI; overweight; life style recommender solution

Outcome Measures

Primary Outcomes (2)

• 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.

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

• Health Lifestyle Recommender system user experience

  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).

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

Secondary Outcomes (33)

• Anthropometric measurements (1/4)

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

• Anthropometric measurements (2/4)

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

• Anthropometric measurements (3/4)

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

• Anthropometric measurements (4/4)

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

• Physical activity and fitness (1/4)

  3 month intervention period from baseline (Day 1) to final measurement (Day 90)

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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.

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• European Commission: collaborator

Study Sites (1)

Clinical and Epidemiological Investigation Center CIEC- LCTR

Luxembourg, L-1445, Luxembourg

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Torsten Bohn PhD, Adjunct Associate Professor

CONTACT

621763805; Torsten.Bohn@lih.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The project is a pilot study. It is a single-group study where participants will be their own control (i.e. outcome measures at the end of study will be compared to baseline). 30 participants will be included. It consists of samples and data collection, together with a mobile application that allows dispensing an intervention that will last 3 months. This pilot study will be 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. Should the participants complete the study, the individual duration will be 3 months. Investigators foresee that, in total, given the various enrolments of the participants, up to 6 months may be necessary for all participants to complete the entire study.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 10, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-09

Locations

LU (1)