NCT06997510Not yet recruiting
Better4All Personalized Intervention
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1022 (estimated)
- First submitted
- 25 Apr 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Harokopio University
- Diseases
- Obesity
- NCT number
- NCT06997510
What you commit to
- Study type: Interventional
- Planned participants: 1022
- From 1 Oct 2025 to the primary completion date, 1 Jun 2026
- 7 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cyprus (Ucy) Coordinator of this site? Confirm its status | Nicosia | Cyprus | Unknown status |
| Universidad de Navarra (Unav) Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Universite Lyon 1 Claude Bernard (Ucbl) Coordinator of this site? Confirm its status | Villeurbanne | France | Unknown status |
| Harokopio University Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Uniwersytet Swps (Swps) Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss) Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Karolinska Institutet (Ki) Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.