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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorFundació d'investigació Sanitària de les Illes Balears

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention Group

    Behavioral

    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.

Treatment groups

2,720 Participants
are divided into 3 treatment groups
Group A: School-children (including families)Experimental treatment 1 intervention
Group B: Young adultsExperimental treatment 1 intervention
Group C: Elderly peopleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and every 3 months up to 12 months

Secondary outcomes

1

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).

Time frame
Baseline and every 3 months up to 12 months
2

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

Time frame
Baseline and every 6 months up to 12 months

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: