Better4All Personalized Intervention Pilot Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The BETTER4U project (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) is funded by the European Union (EU) and involves an international consortium consisting of 28 partners across Europe, Israel, and Australia. The project started in November 2023 and will run until October 2027. The main aim of BETTER4U is to improve weight management through a tailor-made intervention, the BETTER4ALL personalized intervention, using modern monitoring tools and artificial intelligence (AI), including machine learning (ML) practices. In the context of the BETTER4U project, the present Pilot Study aims to a) evaluate the usability, feasibility and acceptability of the BETTER4U mobile application (BETTER4U App) and Intervention Platform that will be used to monitor and collect data from participants in the BETTER4ALL personalized intervention (randomized controlled trial; RCT) and b) collect data to evaluate and improve the BETTER4U causal AI models for the prevention of weight gain, before deploying them at large scale, as well as test and identify the optimal ways of delivering the AI-based interventions to the participants. The study will be conducted in seven sites in Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden. The BETTER4All Pilot Study will be a longitudinal, correlational, observational study, including a total of n=490 participants, equally distributed among the seven sites (i.e. n=70 per site). Specifically, n=60 (± 3-5) general population participants (henceforth: end-users of the wearables and the BETTER4U App) and n=10 (± 3-5) healthcare or other types of providers (henceforth: potential implementers of the BETTER4U intervention) will constitute each site's sample. The study will involve the following two components: a) the administration of the wearables (smartwatches) to the end-users and their registration to and training on the BETTER4U App, to be used for a total duration of three weeks (21 days). During this period, their lifestyle behaviours (i.e. BETTER4U Core Behavioural Indicators - BCBIs, such as eating occasions, physical activity, sedentary time, sleep etc.) and living environment indicators - LEIs; (e.g. access to parks in your area, distance from your home to your work place etc.) will be recorded daily, either in an automated way via the wearables or self-reported by the end-users through the App; and b) the registration to and training on the BETTER4U Intervention Platform of the implementers for a total duration of one week (7 days), during which they will be asked to test the platform's functionalities using synthetic data. The implementers will also be provided with the wearables and the App (similarly to the end-users) for one week only to allow collection of additional data that will help verify the accuracy of the algorithms in the gathered data from the wearables/monitoring tools regarding BCBIs and LEIs. Overall, the outcomes and the findings of the Pilot Study will be used to further refine, optimize, and adjust the tools for the BETTER4ALL RCT, according to the feedback received by both end-users' and implementers' perspectives.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Age: Participants aged 18-65 years to represent the adult general population.

• Body Mass Index (BMI):

‣ Overweight or obesity group: BMI ≥ 25 kg/m².

⁃ Normal weight group: BMI 18.5-24.9 kg/m².

• Technology Use:

‣ Willingness and ability to use wearable devices and an Android mobile application for the duration of the study.

⁃ Owning a smartphone device with the Android operating system.

• Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon.

• Language Proficiency: Ability to read and understand the language in which the mobile app and study materials are provided.

• Consent: Willing to provide informed consent to participate in the study.

• Residency: Must be a resident of one of the seven participating countries.

• Availability: Able to participate for the full three-week duration of the study and comply with the study protocol.

Locations
Other Locations
Cyprus
University of Cyprus (Ucy)
RECRUITING
Nicosia
France
Universite Lyon 1 Claude Bernard (Ucbl)
RECRUITING
Villeurbanne
Greece
Harokopio University
RECRUITING
Athens
Poland
Uniwersytet Swps (Swps)
RECRUITING
Wroclaw
Portugal
Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss)
RECRUITING
Lisbon
Spain
Universidad de Navarra (Unav)
RECRUITING
Pamplona
Sweden
Karolinska Institutet
RECRUITING
Huddinge
Contact Information
Primary
Yannis Manios, Professor
manios@hua.gr
2109549156
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 490
Treatments
Other: End-users - General Population Participants
Adults from the general population (aged 18- 65 years, with normal weight or overweight/obesity) who will use the BETTER4U mobile application and a wearable smartwatch for 21 days. During this period, lifestyle behaviors and living environment indicators will be recorded daily, either automatically via the wearable or through self-reports via the app.
Other: Implementers - Healthcare Professionals
Healthcare professionals (e.g., medical doctors, dietitians/nutritionists, psychologists, nurses) who will use the BETTER4U Intervention Platform, mobile application, and wearable smartwatch for 7 days. During this period, they will interact daily with the Intervention Platform using synthetic data to evaluate its functionalities and usability. Additionally, they will wear the smartwatch and use the app to record lifestyle behavior and living environment indicators (LEIs). They will provide structured growth truth data (e.g., transportation mode, activity levels, sleep quality) to validate the accuracy of the AI algorithms. Their feedback will help optimize their intervention delivery system and AI-based tools before large-scale deployment.
Related Therapeutic Areas
Sponsors
Collaborators: University SWPS, Karolinska Institutet, UNIVERSITE LYON 1 CLAUDE BERNARD (UCBL), University of Navarra, University of Cyprus, CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS (CEIDSS)
Leads: Harokopio University

This content was sourced from clinicaltrials.gov