AI‐Driven Personalized Recommendations and Real‐Time Monitoring for the Prevention and Management of Obesity: Clinical Trial Protocol for the Multicentre BETTER4All Personalized Intervention
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: . 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.
Authors
- Eva Karaglani (ORCID: https://orcid.org/0000-0001-5395-7023)
- Christos Diou (ORCID: https://orcid.org/0000-0002-2461-1928)
- Paris Kantaras (ORCID: https://orcid.org/0000-0003-0794-2511)
- Maira Bes‐Rastrollo (ORCID: https://orcid.org/0000-0002-9139-4206)
- Vanessa Bullón‐Vela (ORCID: https://orcid.org/0000-0003-3639-821X)
- Dimitrios Aletras
- Anastasios N. Delopoulos (ORCID: https://orcid.org/0000-0001-8220-8486)
- Aristotelis Ballas (ORCID: https://orcid.org/0000-0003-1683-8433)
- George V. Dedoussis (ORCID: https://orcid.org/0000-0002-7798-6221)
- Panagiota Veloudi (ORCID: https://orcid.org/0000-0001-6707-7836)
- Paulina Krzywicka (ORCID: https://orcid.org/0000-0002-1959-7535)
- Aleksandra Łuszczyńska (ORCID: https://orcid.org/0000-0002-4704-9544)
- Constantinos C. Deltas (ORCID: https://orcid.org/0000-0001-5549-9169)
- Ioannis Ioakeimidis (ORCID: https://orcid.org/0000-0002-7208-1722)
- Stavroula Georgia Mougiakakou (ORCID: https://orcid.org/0000-0002-6355-9982)
- Louise Seconda (ORCID: https://orcid.org/0000-0003-3460-5457)
- Ana Isabel Rito (ORCID: https://orcid.org/0000-0002-4356-6202)
- Julie‐Anne Nazare (ORCID: https://orcid.org/0000-0003-3545-3264)
- Maria Kafyra (ORCID: https://orcid.org/0009-0005-9665-0829)
- Alexis Kyriacou (ORCID: https://orcid.org/0000-0003-1695-0580)
- Vera Stavroulaki (ORCID: https://orcid.org/0000-0002-2918-6422)
- Yannis Μanios (ORCID: https://orcid.org/0000-0001-6486-114X)
- Ioannis Papathanail (ORCID: https://orcid.org/0000-0002-7767-3831)
- Anna E Ek (ORCID: https://orcid.org/0000-0002-2179-8408)
- Anestis Dougkas (ORCID: https://orcid.org/0000-0002-1954-1531)
- Gianna E. Karanasiou
- Chrysa Episkopou (ORCID: https://orcid.org/0009-0002-6211-5746)
- Ioanna Panagiota Kalafati (ORCID: https://orcid.org/0000-0001-5572-7491)
- Vasiliki Vavouraki (ORCID: https://orcid.org/0009-0001-8269-4477)
- Rooholla Poursoleymani (ORCID: https://orcid.org/0009-0002-4365-6782)
- Christina Patmiou (ORCID: https://orcid.org/0009-0001-4676-6613)
- Ioannis Roumeliotis
- Marta Gaspar
Institutions
- Université Claude Bernard Lyon 1 (FR)
- University of Bern (CH)
- Bern University of Applied Sciences (CH)
- University of Thessaly (GR)
- Inserm (FR)
- Aristotle University of Thessaloniki (GR)
- Mediterranean University (ME)
- Instituto de Salud Carlos III (ES)
- Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition (ES)
- Karolinska Institutet (SE)
- Hellenic Mediterranean University (GR)
- Harokopio University of Athens (GR)
- University of Cyprus (CY)
- Uniwersytet SWPS (PL)
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR)
- Navarre Institute of Health Research (ES)
- WINGS ICT Solutions (Greece) (GR)
- Centre de Recherche en Nutrition Humaine Rhône-Alpes (FR)
- Laboratoire de recherche en cardiovasculaire, métabolisme, diabétologie et nutrition (FR)
- National Institute of Health Dr. Ricardo Jorge (PT)
- Universidad de Navarra (ES)
Publication Details
- Journal
- Obesity Reviews
- Published
- 2026-10-27
- DOI
- https://doi.org/10.1111/obr.70243
- Primary Topic
- Nutrition, Genetics, and Disease
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- BioClinica
- Helsingin Yliopisto
- University of Bern
- Queen Mary University of London
- University of Cyprus
- Università degli Studi di Cagliari
- QIMR Berghofer Medical Research Institute
- Government of the United Kingdom
- UK Research and Innovation
- Hellenic Academic Libraries Link
- European Commission
- Weizmann Institute of Science
- Universität Wien
- Karolinska Institutet
- Universiteit Gent
- Universidad de Navarra
- Medizinische Universität Wien
- Aristotle University of Thessaloniki
- Tartu Ülikool
- Harokopio University
- HORIZON EUROPE Framework Programme
- Leibniz-Gemeinschaft
- Staatssekretariat für Bildung, Forschung und Innovation
- Helmholtz Zentrum München