An interventional study of Digital twin for personalized recommendations in Obesity and Obesity-related Medical Conditions, sponsored by University of Évora. Not yet recruiting. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University of Évora · Not applicable, Interventional, and Prevention
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.
At present, numbers of persons with overweight and obesity continue to grow in most countries worldwide. Children and young adults are at risk for different reasons: in the case of children, dietary habits and lifestyle is starting to be developed and if, at this phase, children do not acquire healthy habits, it will be probable that they will have a higher potential to develop obesity and the associated co-morbidities. It is at this stage that food preferences develop. Moreover, children obesity is increasing and it is known that an obese or pre-obese children will have a higher propensity to be an obese adult. For young adults, the risks and concerns are different. Is in this period of life that most people starts an independent life, and consequently decide their food and lifestyle choices, with an increase in irregularity of meals and unhealthy food choices, together with changes in physical activity habits and social or individual pressures. It is essential to give them tools that will allow them to make healthy choices and to have healthy habits, since they will be the future adult population that will raise and inspire the next generation. As solutions to combat the trend toward increasing overweight and obesity are much in need, the present study aims to intervene with the developed healthy lifestyle recommender solution to address various factors known to constitute a risk for developing obesity, including socio-demographic aspects, psychological/behavioural ones, physical activity, dietary patterns, among other. Such a multi-dimensional portfolio approach is believed to be very much needed for the prevention of obesity and co-morbidities, and the personalization of the solution, as well as the nudging/gamification aspects will strive to ensure a high long-term adherence to the developed solution.
The primary objective of the study is to determine whether the developed healthy-lifestyle recommender solution can be successfully applied to the target population (children and their parents), and whether they adhere to using it frequently during the duration of the study.
This will be assessed by adherence time to the lifestyle recommender solution and questionnaires addressing the user-friendliness and limitation or problems encountered. Secondly, the investigators 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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Évora is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of individuals that will have access to the digital tool and that will be followed for their used and efficacy.
Device: Digital twin for personalized recommendations
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
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.
Time frame: At the end of the study, after 3-month intervention.
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.
Time frame: 3-months
Salivary biomarkers of stress
The investigators will study how the intervention will be able to change salivary cortisol and alpha-amylase concentrations.
Time frame: 3-months
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.
Time frame: 3-months
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.
Time frame: At the beginning of the study
No study locations are listed for this record.
Plan to share: No — Individual data will be not shared. Data will be treated and only treated data will be available. Only the PI of the study will be access to the correspondence between participant identification and codification that will be given to each participant. There is no need of having identification of participants to reach the conclusions about the study.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Évora