Better4All Personalized Intervention

NCT06997510 | Not Yet Recruiting

• 1 other identifier: 101080117
• Study Type: interventional
• Target: 1,022
• Locations: 7 countries
• Sites: 7

Brief 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.

Conditions

Obesity Prevention

Keywords

weight management; polygenic risk score; aritificial intelligence; personalized intervention; obesity; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (6)

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

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

• Percentage of weight loss maintenance

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

• Mean change in systolic and diastolic blood pressure

  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

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

• Improvements in other lifestyle parameters and overall quality of life

  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)

Other Outcomes (3)

• Modifications in body composition

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

• Improvements in psychosocial parameters

  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

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

Study Arms (2)

Control arm

OTHER

Participants will receive feedback and counselling from the implementers on their weight status and lifestyle behaviours, based on their measurements/responses during 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. Participants in both the intervention and the control groups will be provided with the wearable (a smartwatch) which will be Bluetooth-paired with their personal smartphone.

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

Intervention arm

ACTIVE COMPARATOR

Participants will receive personalized recommendations from implementers via the Better4U Intervention Platform, based on the AI model and, where available, the participant's PRS and genetic data. Inclusion of genetic information depends on the timing of recruitment, as genotyping results rely on the shipment and analysis timeline at Bioclinica. To ensure this data is incorporated, baseline visits should be scheduled once blood test results are available or expected within 1.5 months. Participants will also receive a structured counselling session based on the Transtheoretical Model (TTM), which assesses readiness to change across six stages. Participants will also receive a personalized hypocaloric diet tailored to support ≥5% weight loss over the 6-month intervention. All participants (intervention and control) will receive a smartwatch, paired via Bluetooth with their smartphone, along with detailed instructions and training on using the device and the BETTER4U App.

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

Interventions

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.

Intervention arm

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.

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead
• 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

Study Sites (7)

University of Cyprus (Ucy)

Nicosia, 2109, Cyprus

Location

Universite Lyon 1 Claude Bernard (Ucbl)

Villeurbanne, 69622 CEDEX, France

Location

Harokopio University

Athens, Aticca, 17676, Greece

Location

Uniwersytet Swps (Swps)

Wroclaw, 53-238, Poland

Location

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

Lisbon, 1649-016, Portugal

Location

Universidad de Navarra (Unav)

Pamplona, Navarre, 31008, Spain

Location

Karolinska Institutet (Ki)

Huddinge, 141 83, Sweden

Location

Related Links

• Better4U website link

MeSH Terms

Conditions

Genetic Risk Score; Obesity

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Yannis Manios, Professor

  Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannis Manios, Professor

CONTACT

+30 2109549156; manios@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicentre, open, parallel group randomized controlled trial (RCT), including two study arms: the intervention and the control arm.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-04

Locations

FR (1); PL (1); ES (1); CY (1); GR (1); SE (1); PT (1)