Obesity and Obesity-related Medical ConditionsUEVCh_HW8NCT06933121
Empowering Healthy Lifestyle Behaviour Through Personalised Intervention Portfolios to Prevent and Control Obesity in Children - UEV Pilot Study
A study testing Digital twin for personalized recommendations in people with Obesity and Obesity-related Medical Conditions, run by University of Évora.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Digital twin for personalized recommendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Digital twin for personalized recommendations
- Keywords
- Obesity, Overweight, Prevention, Digital-twin, Lifestyle
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital twin for personalized recommendationsDevice
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:
- Suggesting personalized meal recommendations,
- Proposing physical activities tailored to the individuals' capabilities and preferences,
- Measuring and considering emotional and psychological parameters,
- 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
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention group | Experimental | Group of individuals that will have access to the digital tool and that will be followed for their used and efficacy. Receives: Device: Digital twin for personalized recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the study, after 3-month intervention.
Secondary outcomes (4)
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.
Measured: 3-months
Salivary biomarkers of stress
The investigators will study how the intervention will be able to change salivary cortisol and alpha-amylase concentrations.
Measured: 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.
Measured: 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.
Measured: At the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start14 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this short-term study, the intervention with a digital solution, with personalized recommendations about lifestyle aspects, will be used to all participants. Data collection will be made at the beginning and at the end of the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsa Lamy, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933121
- Sponsor's protocol ID
- UEVHeightW8Children
- Acronym
- UEVCh_HW8
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Healthy Lifestyle Behaviour Through Personalised Intervention Portfolios to Prevent and Control Obesity in Children - UEV Pilot Study
- ClinicalTrials.gov ID
- NCT06933121
- Acronym / sponsor ID
- UEVCh_HW8 / UEVHeightW8Children
- Keywords
- Obesity, Overweight, Prevention, Digital-twin, Lifestyle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 14 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this short-term study, the intervention with a digital solution, with personalized recommendations about lifestyle aspects, will be used to all participants. Data collection will be made at the beginning and at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| Digital intervention group | Experimental | Device: Digital twin for personalized recommendationsGroup of individuals that will have access to the digital tool and that will be followed for their used and efficacy. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital twin for personalized recommendationsThe 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 | Device | Digital intervention group |
Primary outcome
Adherence to digital tool
Time frame: At 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.
4 secondary outcomes
Changes in BMI
Time frame: 3-months
Salivary biomarkers of stress
Time frame: 3-months
Salivary biomarkers of physiology and metabolism
Time frame: 3-months
Dietary habits
Time frame: At the beginning of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Website of HealthyW8 project, with detailed description about aims, consortium and project.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digital twin for personalized recommendations in people with Obesity and Obesity-related Medical Conditions, run by University of Évora.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa Lamy, PhD (+351266780800, ecsl@uevora.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to digital tool (time frame: At the end of the study, after 3-month intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.