Better4All Personalized Intervention

ConditionObesity Prevention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorHarokopio University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Personalized lifestyle recommendations based on artificial intelligence (AI) and polygenic risk scores (PRS)
Behavioral
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.
Standard care: lifestyle counselling, healthy eating leaflet, and hyocaloric diet targeting ≥5% weight loss in 6 months.
Behavioral
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.

Treatment groups

1,022 Participants

are divided into 2 treatment groups

Group A: Control armOther 1 intervention

Group B: Intervention armActive comparator 1 intervention

Trial outcomes

Primary outcomes

Mean change in BMI

The primary outcome measure will be the mean change in BMI (in kg/m2) from baseline at the end of the 6-month intervention period between the intervention and the control group.

Time frame

Baseline (prior to intervention) Midpoint (3 months - for psychosocial parameters) End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Secondary outcomes

Percentage of participants achieving a ≥ 5% reduction in body weight

Percentage of those achieving a ≥ 5% reduction in body weight at the end of the 6-month intervention period in the intervention vs the control group.

Time frame

Baseline (prior to intervention) Follow-up (12 months from baseline / 6 months post-intervention)

Percentage of weight loss maintenance

Percentage of weight loss maintenance from the end of the 6-month intervention period until the 6-month follow-up assessment in the intervention vs the control group (assessed as a relative percent of the achieved weight loss at the end of the 6-month intervention).

Time frame

End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Mean change in systolic and diastolic blood pressure

Mean change in systolic and diastolic blood pressure (in mmHg) from baseline at the end of the 6-month intervention period and after a 6-month follow-up assessment in the intervention vs the control group.

Time frame

Baseline (prior to intervention) End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Modifications in metabolomic, lipidomic biomarkers, adikokines, cardiometabolic and inflammatory biomarkers, as well as in gut microbiota

Modifications in metabolomic, lipidomic biomarkers, adipokines, cardiometabolic and inflammatory biomarkers, as well as in gut microbiota at the end of the 6-month intervention period compared to baseline.

Time frame

Baseline (prior to intervention) End of intervention (6 months)

Other outcomes

Modifications in body composition

Mean change in percentage of fat mass and fat-free mass, as well as in kg of fat mass and fat-free mass from baseline at the end of the 6-month intervention period and after a 6-month follow-up assessment in the intervention vs the control group.

Time frame

Baseline (prior to intervention) End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Improvements in psychosocial parameters

Improvements in psychosocial parameters (i.e. anxiety, depression, self-regulation, motivation factors, emotion regulation factors) in the middle and at the end of the 6-month intervention period, as well as after a 6-month follow-up assessment in the intervention vs the control group.

Time frame

Baseline (prior to intervention) Midpoint (3 months - for psychosocial parameters) End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Mean change in BMI of offspring/extended family environment of study participants

Mean change in BMI (in kg/m2) of offspring/extended family environment (i.e. in wife/husband and/or children) of study participants from baseline at the end of the 6-month intervention period, as well as after a 6-month follow-up assessment.

Time frame

Baseline (prior to intervention) End of intervention (6 months) Follow-up (12 months from baseline / 6 months post-intervention)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harokopio University

Lead sponsor

University of Navarra

Collaborator

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

Collaborator

University of Cyprus

Collaborator

Karolinska Institutet

Collaborator

University SWPS

Collaborator

Claude Bernard University

Collaborator

Source ClinicalTrials.gov

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