BETTER4All personalized weight-management pilot

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Validating measurements of how much energy your body uses

  This study tests whether measuring energy expenditure in a whole-room calorimeter gives healthy adults a more accurate guide to how much to eat to keep their weight stable.

  Recruiting University of Leipzig · Leipzig, Saxony · NCT07155564

• Improving team-based biopsychosocial training so clinics can deliver recommended obesity care

  This project will test two training methods to help clinic teams (primary care clinicians, behavioral health staff, dietitians, and community health workers) deliver USPSTF-recommended obesity care to patients at Federally Qualified Health Centers.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07049861

• Hands-on nutrition demonstrations added to the Diabetes Prevention Program for people with prediabetes

  This project will test whether adding a 7-week series of healthy cooking and nutrition demos to the Diabetes Prevention Program helps adults at risk for prediabetes stay engaged and put healthy eating into daily life.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT06897982

• Dairy intake and metabolic health in teens and older adults

  This project will test whether eating three servings of dairy each day helps overweight or obese teens (15–18) and older adults (60–80) improve weight, body composition, and metabolic health over six months.

  Recruiting University of Toronto · Toronto, Ontario and 1 other locations · NCT06879652

• Preventing obesity in American Indian 4th graders at rural tribal schools

  This project will test whether a culturally relevant health and activity curriculum can help prevent obesity in 4th grade American Indian students at rural tribal schools.

  Recruiting Northern Arizona University · Flagstaff, Arizona and 2 other locations · NCT06864468

• Calorie-reduced Mediterranean diet plus activity program to lower chronic disease risk in 30–50-year-olds

  This program will try a 25% calorie-reduced Mediterranean diet combined with increased physical activity to help 30–50-year-olds with metabolic syndrome lose weight and improve cardiometabolic health.

  Recruiting IMDEA Food · Madrid, Madrid · NCT06857929

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.