Better4All Personalized Intervention

Launched by HAROKOPIO UNIVERSITY · May 21, 2025

Keywords

ClinConnect Summary

The BETTER4U project is a clinical trial focused on helping people manage their weight more effectively, particularly those who are overweight or obese. The study aims to personalize weight loss strategies by using advanced technology, including artificial intelligence (AI) and genetic information, to create tailored lifestyle recommendations. Participants in the trial will either receive these personalized plans or standard care recommendations for six months, and then their progress will be monitored for another six months. This research could lead to better methods for weight management that take into account individual differences in genetics and lifestyle.

To be eligible for this trial, participants must be between 18 and 65 years old and have a Body Mass Index (BMI) of 25 or higher, which indicates they are overweight or obese. They should also be comfortable using a smartphone and wearable devices to track their physical activity, sleep, and eating habits during the study. However, certain health conditions or recent weight changes may disqualify some individuals. Participants can expect to engage with a mobile app that guides them through the intervention, and they'll have their weight, health markers, and lifestyle changes assessed throughout the study. This trial not only aims to improve individual health but also hopes to contribute to public health strategies for obesity prevention.

Gender

ALL

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