BETTER4All personalized weight-management pilot
Better4All Personalized Intervention Pilot Study
This pilot tests whether a personalized smartphone app plus a smartwatch using AI can monitor daily behaviors and support weight management for adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Harokopio University Academic / other |
| Locations | 7 sites (Nicosia and 6 other locations) |
| Trial ID | NCT07120802 on ClinicalTrials.gov |
What this trial studies
This multicenter, longitudinal pilot enrolls about 490 adults across seven European countries to test the usability and feasibility of the BETTER4U mobile app, wearable, and intervention platform. Participants in the end-user group will use a Bluetooth Low Energy smartwatch and the Android app for 21 days, while healthcare implementers will test the platform for 7 days with synthetic and self-recorded data. Wearables collect accelerometer, heart rate variability, sleep, and location signals that are processed locally and on secure servers using machine learning to derive core behavioral and environmental indicators. Data sources include passive sensor data, online questionnaires, and platform usage logs, with GDPR-aligned privacy protections and centralized pipelines to refine AI-driven causal models.
Who should consider this trial
Good fit: Adults aged 18–65 who live in one of the participating countries, own an Android smartphone, are willing to wear a provided smartwatch, and can read the study language are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, lack an Android smartphone, cannot use wearable technology, or live outside the seven participating countries are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the system could deliver more personalized, timely behavior support that helps people maintain healthier habits and reduce obesity risk.
How similar studies have performed: Previous app-plus-wearable interventions have shown modest improvements in activity and behavior change, but fully AI-driven, causal personalized approaches at multicountry scale remain relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: Participants aged 18-65 years to represent the adult general population. * Body Mass Index (BMI): * Overweight or obesity group: BMI ≥ 25 kg/m². * Normal weight group: BMI 18.5-24.9 kg/m². * Technology Use: * Willingness and ability to use wearable devices and an Android mobile application for the duration of the study. * Owning a smartphone device with the Android operating system. * Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon. * Language Proficiency: Ability to read and understand the language in which the mobile app and study materials are provided. * Consent: Willing to provide informed consent to participate in the study. * Residency: Must be a resident of one of the seven participating countries. * Availability: Able to participate for the full three-week duration of the study and comply with the study protocol. Exclusion Criteria: * Health Conditions: Pregnant or breastfeeding women, as they might have different lifestyle behaviours or health needs. * Physical Limitations: Any physical or mental condition that would prevent the participant from using the wearable device or mobile application as intended. * Eating utensil technique: eating food with chopsticks on a daily or regular basis. * Technical Incompatibility: Individuals who do not own a compatible smartphone or are unable to use the provided wearable devices for technical reasons.
Where this trial is running
Nicosia and 6 other locations
- University of Cyprus (Ucy) — Nicosia, Cyprus (Recruiting)
- Universite Lyon 1 Claude Bernard (Ucbl) — Villeurbanne, France (Recruiting)
- Harokopio University — Athens, Aticca, Greece (Recruiting)
- Uniwersytet Swps (Swps) — Wroclaw, Poland (Recruiting)
- Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss) — Lisbon, Portugal (Recruiting)
- Universidad de Navarra (Unav) — Pamplona, Navarre, Spain (Recruiting)
- Karolinska Institutet — Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Yannis Manios, Professor — Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
- Study coordinator: Yannis Manios, Professor
- Email: manios@hua.gr
- Phone: 2109549156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.