Clinical trial NCT06816147: HealthyW8_65+ Pilot
Official title: Empowering Healthy Lifestyle Behavior Through Personalized Intervention Portfolios to Prevent and Control Obesity in the Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity Prevention
Keywords: Obesity
BMI
overweight
life style recommender solution
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
name: University of Luxembourg
First posted: 2025-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: This pilot study will focus on men and women aged ≥65 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 ≥65 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.

Eligibility criteria: Inclusion Criteria:

Individuals aged 65 or older:

* both males/females, general free-living population,
* residing in Luxembourg,
* being overweight, i.e., with a BMI above 25 but below 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.

Primary outcomes:
measure: Health Lifestyle Recommender System adherence time
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Health Lifestyle Recommender system user experience
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
Secondary outcomes:
measure: Anthropometric measurements (1/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Anthropometric measurements (2/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Anthropometric measurements (3/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Anthropometric measurements (4/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Physical activity and fitness (1/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Physical activity and fitness (2/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Physical activity and fitness (3/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Physical activity and fitness (4/4)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Clinical measurements
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (1/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (2/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (3/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (4/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (5/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (6/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (7/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (8/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (9/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (10/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (11/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Biochemical analysis (12/12)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Diet analysis (1/3)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Diet analysis (2/3)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Diet analysis (3/3)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements(1/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (2/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (3/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (4/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (5/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (6/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (6/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (7/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
measure: Lifestyle measurements (9/9)
timeFrame: 3 month intervention period from baseline (Day 1) to final measurement (Day 90)
Other outcomes:
Locations:
Study officials:
References: