Better4All Personalized Intervention
Trial ID: NCT06997510
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-10-01
Completion date: 2027-04-01
Sponsor: Harokopio University
Collaborators: University of Navarra; CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS; University of Cyprus; Karolinska Institutet; University SWPS; Claude Bernard University
Conditions: Obesity Prevention
Interventions: Personalized lifestyle recommendations based on artificial intelligence (AI) and polygenic risk scores (PRS); Standard care: lifestyle counselling, healthy eating leaflet, and hyocaloric diet targeting ≥5% weight loss in 6 months.
Locations: University of Cyprus (Ucy); Universite Lyon 1 Claude Bernard (Ucbl); Harokopio University; Uniwersytet Swps (Swps); Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss); Universidad de Navarra (Unav); Karolinska Institutet (Ki)
Countries: Cyprus; France; Greece; Poland; Portugal; Spain; Sweden
Enrollment: 1022
Age range: 18 Years - 65 Years
Sex: ALL

Summary:
The BETTER4U (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) project, funded by the European Union, aims to address obesity through biologically and behaviourally tailored interventions. Obesity is a major public health issue influenced by genetic, metabolic, and lifestyle factors. Despite current weight management interventions, many individuals face challenges due to these varied influences. The BETTER4U project seeks to improve weight management by incorporating artificial intelligence (AI) and polygenic risk scores (PRS) to personalize interventions. The goal is to test the effectiveness of these personalized interventions in improving weight loss compared to standard care, using advanced monitoring tools and AI models.

The BETTER4ALL personalized intervention is a multicentre, open-label, parallel-group randomized controlled trial (RCT) involving seven study sites across Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden. A total of 1,022 participants with overweight or obesity (BMI ≥ 25 kg/m²), aged 18-65 years, will be enrolled. Participants will be randomized into two groups: an intervention group receiving personalized lifestyle recommendations based on AI and PRS, and a control group receiving standard care recommendations. The intervention will last six months, followed by a six-month follow-up assessment.

The intervention's key aspects include wearable devices and a mobile application to monitor participants' behaviour, including physical activity, sleep, and eating habits. The intervention also integrates genetic, metabolic, and environmental data to provide tailored recommendations for weight loss. Participants' outcomes will be assessed regarding BMI, weight loss maintenance, changes in clinical biomarkers, body composition, and other lifestyle parameters.

This RCT will provide valuable insights into the effectiveness of personalized weight management strategies. AI-driven personalized recommendations and real-time monitoring represent a significant shift from traditional, one-size-fits-all approaches. The results of this study could offer a more effective and sustainable model for obesity management, particularly by accounting for individual genetic predispositions and lifestyle factors. Furthermore, by evaluating the impact of the intervention on a wide range of health outcomes, including biomarkers and psychosocial factors, the study will provide a comprehensive understanding of how personalized interventions can improve overall health and weight management.

In addition to contributing to the scientific understanding of obesity and its management, this project has the potential to influence public health strategies, offering a more personalized, data-driven approach to obesity prevention and treatment. By integrating genetic, environmental, and lifestyle factors, the BETTER4U intervention could pave the way for future innovations in digital health and obesity management.

Eligibility criteria:
Inclusion Criteria:

* Age: Participant aged 18-65 years
* Body Mass Index (BMI): BMI ≥ 25 kg/m² (overweight or obesity)
* Willingness and ability to use wearable devices and an Android mobile application for the duration of the study
* Owning a smartphone device with Android operating system
* Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon
* Language proficiency: participant has the ability to read and understand the language in which the mobile app and study materials are provided
* Consent: participant is willing to provide informed consent to participate in the study
* Residency: participant is resident of the country
* Availability: participant is able to participate for the full three-week duration of the study and comply with the study protocol

Exclusion Criteria:

* Pregnant or breastfeeding or intending to get pregnant in the short-term
* Comorbidities which might affect inflammation levels (i.e. type 1 diabetes, uncontrolled type 2 diabetes, unstable cardiovascular disease, eating disorders, gastrointestinal disorders)
* Mental illness affecting cognitive and communication skills, lifestyle and/or dietary habits
* History of cancer within 5 years prior to intervention onset
* Physical Limitations: any physical or mental condition that would prevent the participant from using the wearable device or mobile application as intended
* Any other criterion which would deem the participant unsuitable, according to the investigator's impression
* Technical Incompatibility: Individual does not own a compatible smartphone or are unable to use the provided wearable devices for technical reasons
* Documented and/or self-reported rapid changes in body weight in the six months preceding intervention onset, attributed to a diagnosed medical condition
* Interventional drug treatment in a clinical trial in the period within six months prior to intervention onset, which might affect intervention impact
* Inability to adhere to the proposed diet regimens, due to medical (i.e. gluten intolerance, allergies, swallowing problems) or religious reasons
* Medication promoting weight loss
* Bariatric surgery in the 12 months preceding intervention onset
* Use of supplements promoting weight loss or sleep quality, mood enhancing supplements, and/or consumption of probiotics and medications that influence the microbiome in the last three months preceding intervention onset Participation in a different clinical trial protocol or participation in different programs aiming at weight loss during the six months preceding intervention onset

Outcomes:
Mean change in BMI