About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Digital twin for personalized recommendations
DeviceThe 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
Treatment groups
Trial outcomes
Primary outcomes
Adherence to digital tool
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.
Secondary outcomes
Changes in BMI
we will study whether the assessment of endpoints required for the ensuing long-term study can be well assessed within the study and if despite the limited time of the intervention duration, the intervention will be able to improve some markers related to the risk of obesity and associated co-morbidities. Toward this end, change of BMI, relatively to the beginning of the intervention will be assessed.
Salivary biomarkers of stress
The investigators will study how the intervention will be able to change salivary cortisol and alpha-amylase concentrations.
Salivary biomarkers of physiology and metabolism
The levels of different salivary molecules will be measured in the periods before and after intervention, namely: salivary glucose and insulin, salivary C-reactive protein - CRP concentrations.
Dietary habits
The dietary habits of children, at the beginning of the study, will be determined through validated Food Frequency Questionnaires, which will allow to quantify the average amount of each food type consumed per day, as well as the amounts of macro- and micronutrients consumed per day.
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Sponsors and contacts
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