Clinical trial

Empowering Healthy Lifestyle Behaviour Through Personalised Intervention Portfolios to Prevent and Control Obesity in Children - UEV Pilot Study

Opening soon · Not applicable · 0 countries · Registry ID NCT06933121

Opening soonNot applicableInterventional

What this study is about

This study is being performed under the European Consortium HealthyW8 that has the main objective of developing a digital tool for personalized recommendations for healthy lifestyle and prevention of obesity. This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on children (age 5 to 12 y) and parents. The main purpose is to study whether the healthy lifestyle recommender solution, reflecting a multi-portfolio intervention and developed within this project, is well accepted by the participants, has a decent adherence (i.e. user time of the app), and whether the overall design is well suited to the participants, in order that they will improve dietary habits. This study will be of longitudinal design without a control group.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 12 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Obesity-related Medical Conditions

Full registry criteria

Inclusion Criteria: * Children (age 5-12 y) and, at least, one of their parents * To reside in Portugal (for logistic reasons) * To be overweight (BMI percentile \> 85%) * Both boys and girls Exclusion Criteria: * To have manifest chronic diseases (e.g. cancer) * To be already in energy restriction or following a specific diet (on their own or advised by their physician) * To have eating behaviour pathologies

Treatments and study arms

Digital twin for personalized recommendations

Device

The intervention is the developed eHealth solution, i.e. the healthy lifestyle recommender system. It is based on a previously developed meal recommender system, but will be much extended, resulting in a multilevel portfolio intervention regarding: 1. Suggesting personalized meal recommendations, 2. Proposing physical activities tailored to the individuals' capabilities and preferences, 3. Measuring and considering emotional and psychological parameters, 4. Proposing additional healthy life-style patterns regarding e.g. sleeping patterns, alcohol and tobacco consumption, engaging in social activities etc. The detailed nature of the interventions will first be developed during co-creation and then targeted to the participating individual. Moreover, particular attention will be given, since this needs to be a eHealth solution easy to be used by children. The intervention will include collecting urine and saliva samples, as well as measuring anthropometrics and collecting data (persona

Primary outcomes

Adherence to digital toolAt the end of the study, after 3-month intervention.

Adherence time to the lifestyle recommender solution and questionnaires addressing the user-friendliness and limitation or problems encountered. This will be quantified according to the scale of the questionnaires.

Study locations

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No public site location was included in this record. Check the original registry for updates.