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Personalized AI and genetic-based weight loss program for adults with obesity prevention

Tests personalized AI-based lifestyle advice versus standard care in adults with overweight or obesity.

Key facts

Who runs it
Harokopio University
Where
Athens, GreeceSee the siteAlso in 6 other countries, 6 sites
Trial code
Registry title
Better4All Personalized Intervention
Status
Not yet recruiting
People taking part
1,022 people, planned
Started
1 Oct 2025
Expected to end
1 Apr 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 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.
Record updated
30 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-65 with overweight or obesity (BMI ≥ 25 kg/m²) who can use wearable devices and an Android phone app for a lifestyle weight-loss programme.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Overweight or obesity, with a BMI of 25 kg/m² or more.
Earlier treatment
Cannot join if in the six months before the start they took part in another clinical trial with drug treatment or in another weight-loss programme. Also cannot join if they had bariatric surgery in the last 12 months or take weight-loss medication.

Main reasons for not taking part

  • Pregnant, breastfeeding, or planning to become pregnant soon
  • Conditions that may affect inflammation levels, such as type 1 diabetes, uncontrolled type 2 diabetes, unstable cardiovascular disease, eating disorders or gastrointestinal disorders
  • History of cancer within the last 5 years
  • Bariatric surgery in the last 12 months, or medication or supplements that promote weight loss
  • Not owning a compatible Android smartphone or not being able to use the wearable devices

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Interventional drug treatment in a clinical trial in the period within six months prior to intervention onset, which might affect intervention impact
  • 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
  • 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
  • Documented and/or self-reported rapid changes in body weight in the six months preceding intervention onset, attributed to a diagnosed medical condition
  • Inability to adhere to the proposed diet regimens, due to medical (i.e. gluten intolerance, allergies, swallowing problems) or religious reasons
  • Pregnant or breastfeeding or intending to get pregnant in the short-term
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Greece

Also in 6 other countries, 6 sites

  • Harokopio UniversityAthens, GreeceContact: Yannis Manios, ProfessorNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Control armOther group

    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.

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

  • Intervention armExisting treatment, for comparison

    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.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Better4All Personalized Intervention
Plain-language title
Personalized AI and genetic-based weight loss program for adults with obesity preventionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06997510, who can take part
Publications
Record updated
30 May 2025