Better4All Personalized Intervention

NANot yet recruitingINTERVENTIONAL
Enrollment

1,022

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

June 1, 2026

Study Completion Date

April 1, 2027

Conditions
Obesity Prevention
Interventions
BEHAVIORAL

Personalized lifestyle recommendations based on artificial intelligence (AI) and polygenic risk scores (PRS)

"Personalized lifestyle intervention that integrates artificial intelligence (AI), polygenic risk scores (PRS), and real-time behavioral and environmental data. MyBETTER4U dynamically adapts to individual needs by combining genetic and biological profiling (e.g., PRS, microbiome, metabolomics), behavioral determinants (e.g., eating habits, physical activity, sleep patterns), sociodemographic and environmental context, technology-assisted self-monitoring through wearable devices and digital tools, and AI-driven decision-support systems that generate ongoing, individualized recommendations.~Intervention group participants will receive personalized recommendations via the Better4U Platform, based on the AI model and, when available, their PRS and genetic data. Since genotyping results depend on sample processing timelines, baseline visits should be scheduled when results are available or expected within 1.5 months to ensure inclusion in the next visit."

BEHAVIORAL

Standard care: lifestyle counselling, healthy eating leaflet, and hyocaloric diet targeting ≥5% weight loss in 6 months.

"Participants will receive feedback and counselling from the implementers on their weight status and lifestyle behaviours, based on their measurements/responses during the screening assessment. This counselling will be based on the general healthy eating (based on the Mediterranean diet) and healthy lifestyle recommendations for physical activity, sedentary time, and sleep (based on WHO recommendations) and will be considered the standard care. Those recommendations will also be handed in to them in the form of a standard care leaflet to take home. Participants will also be provided with a standard hypocaloric diet based on their needs for weight loss, aiming for a ≥ 5% reduction in body weight at the end of the 6-month intervention period."

Trial Locations (7)

2109

University of Cyprus (Ucy), Nicosia

17676

Harokopio University, Athens

31008

Universidad de Navarra (Unav), Pamplona

69622 CEDEX

Universite Lyon 1 Claude Bernard (Ucbl), Villeurbanne

53-238

Uniwersytet Swps (Swps), Wroclaw

1649-016

Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss), Lisbon

141 83

Karolinska Institutet (Ki), Huddinge

All Listed Sponsors
collaborator

University of Navarra

OTHER

collaborator

CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS

UNKNOWN

collaborator

University of Cyprus

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

University SWPS

OTHER

collaborator

UNIVERSITE LYON 1 CLAUDE BERNARD (UCBL)

UNKNOWN

lead

Harokopio University

OTHER

NCT06997510 - Better4All Personalized Intervention | Biotech Hunter | Biotech Hunter