Actively Recruiting
Better4All Personalized Intervention Pilot Study for Obesity Prevention Using AI and Wearable Technology
Led by Harokopio University · Updated on 2025-08-13
490
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Harokopio University
Lead Sponsor
U
University of Navarra
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the BETTER4U personalized intervention aimed at preventing obesity by improving weight management through tailored behavioral and biological strategies. This pilot study, part of a broader European Union-funded project, seeks to assess the usability, feasibility, and acceptability of the BETTER4U mobile application and intervention platform. The study involves adults aged 18 to 65 from seven countries, focusing on collecting data to refine AI models designed to support personalized weight management interventions. The study includes two main groups: general population participants, called "end-users," who will use a smartwatch and the BETTER4U mobile app for 21 days to monitor lifestyle behaviors such as eating, physical activity, sedentary time, and sleep, as well as environmental factors. Healthcare professionals, called "implementers," will test the BETTER4U Intervention Platform and app for 7 days using synthetic data and their own wearable data to assess system usability and validate AI algorithms. Both groups receive training on their respective tools at the start of their participation periods. Participants will regularly use wearable devices and the mobile app to collect passive data and self-reports, complete online questionnaires, and provide feedback on usability and acceptability through validated surveys. Researchers will measure outcomes such as system usability, intervention acceptability, feasibility, and appropriateness scores at the end of each group's participation period. The collected data will help optimize AI models and intervention delivery methods before a larger randomized controlled trial. Total participation lasts 21 days for end-users and 7 days for implementers, with ongoing monitoring of app usage and engagement metrics.
CONDITIONS
Brief Title
Better4All Personalized Intervention Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Body Mass Index (BMI) 18.5-24.9 kg/m² (normal weight) or BMI ≥ 25 kg/m² (overweight or obesity)
- Willingness and ability to use wearable devices and an Android mobile app for the study duration
- Own a smartphone with the Android operating system
- Use dominant hand gestures involving fork or spoon for eating
- Ability to read and understand the study language
- Provide informed consent
- Resident of one of the seven participating countries
- Available to participate for the full three-week study period and comply with study protocol
You will not qualify if you...
- Pregnant or breastfeeding women
- Any physical or mental condition preventing use of the wearable device or mobile app as intended
- Regular or daily use of chopsticks for eating
- Not owning a compatible smartphone or unable to use wearable devices due to technical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 21 days
Participants use the BETTER4U mobile app and a smartwatch to record lifestyle behaviors and environmental data daily. End-users wear the devices and self-report certain behaviors for 21 days to assess usability and collect real-world data.
Daily use with passive data collection and self-reporting via app
Duration - 7 days
Healthcare professionals test the BETTER4U Intervention Platform and mobile app for 7 days, engaging with synthetic case simulations and providing daily feedback while wearing the smartwatch and using the app for data validation.
Daily interaction with platform and app
Trial Site Locations
Total: 7 locations
1
University of Cyprus (Ucy)
Nicosia, Cyprus, 2109
Actively Recruiting
2
Universite Lyon 1 Claude Bernard (Ucbl)
Villeurbanne, France, 69622 CEDEX
Actively Recruiting
3
Harokopio University
Athens, Aticca, Greece, 17676
Actively Recruiting
4
Uniwersytet Swps (Swps)
Wroclaw, Poland, 53-238
Actively Recruiting
5
Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss)
Lisbon, Portugal, 1649-016
Actively Recruiting
6
Universidad de Navarra (Unav)
Pamplona, Navarre, Spain, 31008
Actively Recruiting
7
Karolinska Institutet
Huddinge, Sweden, 141 83
Actively Recruiting
Research Team
Y
Yannis Manios, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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