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

NCT07011368 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2720

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

  • Obesity and Overweight
  • Obesity Prevention
  • Obesity and Obesity-related Medical Conditions
  • Digital Health
  • Behavioural Science Interventions to Improve Health Equity

Interventions

BEHAVIORAL

Intervention Group

Healthy Lifestyle Recommender Solution (HLRS) will be developed as intervention tool for the trials. It integrates tools (mostly digital): a meal recommender to propose balanced and individually adapted meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features for sustained engagement and adherence. Within our multi-disciplinary portfolio approach, a set of predominantly eHealth solutions applied during the intervention trials for overweight/obesity prevention, developed in a participatory design approach with relevant stakeholders. This will include the HLRS, thus combining motivational features (nudging, gamification), targeted psychological support, dietary and physical activity advice, though also additional recommendations (healthy eating guidelines...) or education materials will be provided. Intervention trials/studies.

Sponsors & Collaborators

  • Luxembourg Institute of Health

    collaborator OTHER_GOV
  • University of Évora

    collaborator OTHER
  • University of Coimbra

    collaborator OTHER
  • Eindhoven University of Technology

    collaborator OTHER
  • Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH

    collaborator OTHER
  • Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI)

    collaborator UNKNOWN
  • Technical University of Denmark

    collaborator OTHER
  • Fundació d'investigació Sanitària de les Illes Balears

    lead OTHER_GOV

Principal Investigators

  • Torsten Bohn, PhD · Luxembourg Institute of Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-07-15
Completion
2028-06-30

Countries

  • Bulgaria
  • Denmark
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011368 on ClinicalTrials.gov