AI‐Driven Personalized Recommendations and Real‐Time Monitoring for the Prevention and Management of Obesity: Clinical Trial Protocol for the Multicentre BETTER4All Personalized Intervention
Abstract
ABSTRACT Background Obesity arises from complex interactions among genetic, biological, behavioral, and environmental factors. Traditional “one‐size‐fits‐all” interventions often yield modest, short‐term outcomes, failing to account inter‐individual variability. Advances in artificial intelligence (AI), polygenic risk scores (PRS), and digital health technologies now enable personalized and adaptive lifestyle interventions. Objective This paper presents the design and evaluation framework of the BETTER4All personalized intervention, a multicentre randomized controlled trial within the EU‐funded BETTER4U project. The trial aims to integrate biological and behavioral data into tailored obesity prevention and management strategies. Methods The BETTER4All trial will be conducted across seven European countries, targeting 1022 adults with body mass index (BMI) ≥ 25 kg/m 2 . Participants will be randomized to an intervention group receiving AI and PRS‐based lifestyle recommendations via a smartphone application, wearable device, and structured counseling, or to a control group receiving standard hypocaloric diet and lifestyle advice. The primary outcome is change in BMI at 6 months. Secondary outcomes include weight‐loss maintenance at 1 year, metabolomic and gut microbiota biomarkers, lifestyle behaviors, and psychosocial parameters. Process evaluation incorporates measures of fidelity, acceptability, feasibility, and appropriateness, alongside adherence metrics from the digital tools. Conclusion The BETTER4All trial will provide evidence on the effectiveness and scalability of AI‐driven, biologically informed personalization in obesity care, offering a methodological framework for integrating multimodal digital data, from omics and biomarkers to behavior and lifestyle, contributing to the advancement of precision public health strategies. Trial Registration: ClinicalTrials.gov identifier: NCT06997510
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Authors: Eva Karaglani, Christina Patmiou, Paris Kantaras, Ioanna Panagiota Kalafati, Maria Kafyra, Vasiliki Vavouraki, Marta Gaspar, Ana Isabel Rito, Louise Seconda, Anestis Dougkas, Julie‐Anne Nazare, Anna E Ek, Ioannis Ioakeimidis, Alexis Kyriacou, Panagiota Veloudi, Constantinos C. Deltas, Vanessa Bullón‐Vela, Maira Bes‐Rastrollo, Paulina Krzywicka, Aleksandra Łuszczyńska, Dimitrios Aletras, Chrysa Episkopou, Anastasios N. Delopoulos, Gianna E. Karanasiou, Vera Stavroulaki, Rooholla Poursoleymani, Ioannis Papathanail, Stavroula Georgia Mougiakakou, Ioannis Roumeliotis, Aristotelis Ballas, Christos Diou, George V. Dedoussis, Yannis Μanios
Institutions: Karolinska Institutet, Inserm, Instituto de Salud Carlos III, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Bern, University of Thessaly, Lyon 1 Université, Bern University of Applied Sciences, Aristotle University of Thessaloniki, Mediterranean University, Harokopio University of Athens, Universidad de Navarra, University of Cyprus, Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition, Navarre Institute of Health Research, National Institute of Health Dr. Ricardo Jorge, Uniwersytet SWPS, Laboratoire de recherche en cardiovasculaire, métabolisme, diabétologie et nutrition, Centre de Recherche en Nutrition Humaine Rhône-Alpes, WINGS ICT Solutions (Greece)