About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Overweight (BMI between 25-30 kg/m²)
To have a smart phone
Disqualifiers
Individuals with manifest chronic diseases
Individuals with cognitive diseases
Individuas not able to lead an independent life
Trial design
Parallel
Treatments tested in this trial
Intervention Group
BehavioralHealthy 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in BMI
The Primary Outcome (to be measured every 3 months) will be the change of BMI (kg/m\^2) measuring body weight in kilograms and height in meters\^2 as combined to obtain BMI data (kg/m\^2) after the 12-month intervention of healthy lifestyle recommender solutions (HLRS) in the selected age groups (5-12 y.o. children and families; 18-25 y.o. young adults; and \>65 y.o. elderly people).
Secondary outcomes
Change of visceral body fat
The Secondary Outcome (to be measured every 3 months) will be the change of visceral body fat measuring body fat in kilograms and in percentage of body weight after the 12-month intervention of healthy lifestyle recommender solutions (HLRS) in the selected age groups (5-12 y.o. children and families; 18-25 y.o. young adults; and \>65 y.o. elderly people).
Body composition and biomarkers
Other Secondary outcomes will be several biological markers measured every 6 months: * lipidic profile (cholesterol, LDL-c, HDL-C, triglycerides): mg/dL * glycidic profile (fasting blood glucose, HbA1C, insulin): mg/dL * inflammatory biomarkers (CRP, IL-1b/6/8, TNFa) * oxidative stress biomarkers (F2-isoprostanes, malondialdehyde): ng/mL * nutrition related markers: vitamin E, total carotenoids, total phenolics, sodium in urine: ng/dL * gut microbiome analyses (16S rRNA): assessment of bacterial species
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació d'investigació Sanitària de les Illes Balears
Lead sponsor
Luxembourg Institute of Health
Collaborator
University of Évora
Collaborator
University of Coimbra
Collaborator
Eindhoven University of Technology
Collaborator
Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
Collaborator
Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI)
Collaborator
Technical University of Denmark
Collaborator
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