Clinical Trial

Empowering Healthy Lifestyle Personalised Intervention to Prevent and Control Obesity: The HealthyW8 Project

Study acronym: HealthyW8
Not Yet Recruiting
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Record status
This record was last updated July 1, 2025 (before its estimated July 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of the HealthyW8 study (an intervention study) is: To assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (\>65 y). The main questions it aims to answer are: Outcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight/obesity among the described age groups. Outcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight/obesity at described ages. Researchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight/obesity, and related parameters (body composition and biomarkers). Participants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-30.
Trial Details
NCT Number NCT07011368
Lead Sponsor Fundació d'investigació Sanitària de les Illes Balears
Collaborators: Luxembourg Institute of Health, University of Évora, University of Coimbra, Eindhoven University of Technology, Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH, Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI), Technical University of Denmark
Conditions Obesity Prevention, Obesity and Overweight, Obesity and Obesity-related Medical Conditions, Digital Health, Behavioural Science Interventions to Improve Health Equity
Enrollment 2,720 participants
Start Date 2025-07-01
Primary Completion 2025-07-15 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-01