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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Change in BMI — Baseline and every 3 months up to 12 months
  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).

Trial sites (13)

Other trials for the same condition