Obesity Reviews · Oct 27, 2026
AI-Driven Personalized Recommendations and Real-Time Monitoring for the Prevention and Management of Obesity: Clinical Trial Protocol for the Multicentre BETTER4All Personalized Intervention
By Karaglani E, Patmiou C, Kantaras P et al.
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/m². 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.