ObeseHW8YAPilotNCT06943651
Empowering Healthy Lifestyle Behavior to Prevent and Control Obesity in Young Adults
A study testing HealthyW8 Digital Twin of healthy lifestyle recommendations in people with Obese and Overweight, run by University of Évora.
Trial summary
This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on young adults (age 18 to 25 y). The main purpose is to study whether the healthy lifestyle recommender solution, reflecting a multi-portfolio intervention and developed within this project, is well… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obese, Overweight
- What is being tested?
- HealthyW8 Digital Twin of healthy lifestyle 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
- 21 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be young adult (age 18-25 y)
- To reside in Portugal
- To be overweight (BMI between 25-30 kg/m2)
- Women and men
Who cannot join
- To have a 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 behavior 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
Official title: Empowering Healthy Lifestyle Behaviour Through Personalized Intervention Portfolios to Prevent and Control Obesity in Young Adults - A Pilot Study
This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on young adults (age 18 to 25 y). 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. Young adults are at risk since in in this period of life most people start to be independent from their families, with the consequent decisions about their food and lifestyle choices. It is frequent that at this time an increase in irregularity of meals and unhealthy food choices, occurs, together with changes in physical activity habits and social or individual pressures. Because of this, it is essential to give tools to these individuals 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.
Read the detailed description
The applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis.
The investigators judge the risk for the participant as low, since only saliva will be collected which collection is totally non-invasive. The administered intervention is expected to be effective, based on the multi-level nature of the tools applied.
This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.
The investigators are aware of the potential influence of seasons and other longitudinal changes on the outcomes, however as the endpoints are rather motivation and adherence, the investigators deem the design as appropriate. Moreover, in case of salivary parameters, which can be more sensitive to this type of variation, the collection in three successive days, before and at the end of the trial (to be analysed as pooled samples) will minimize these potential effects.
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. The intervention will include collecting urinary and saliva samples, as well as measuring anthropometrics and collecting data (personal, socio-demographics, general health and well-being, physical activity and eating patterns, among other) via questionnaires.
The study duration will be 3 months from the official start to the end. Following a first interview to test participants eligibility, the investigators have compiled a list of exemplary endpoints in the following, providing an overview about the sampling frequency.
Young adults (age 18-25 y) will be recruited via university and local hospital (Hospital do Espirito Santo - Évora), with help from the researchers from the School of Health Sciences, by direct advertisement and by recommendation of Hospital dietitians. The run-in time of the study will be long enough to assure recruitment of the required number of persons. The participants will be followed up regularly by phone-calls from the team of the University of Évora (e.g. weekly), and via contact maintained through the developed healthy lifestyle recommender solution. Should recruitment be insufficient, additional advertisement via local newspapers will be carried out, and the run-in time be extended.
Participants will receive the developed healthy lifestyle recommender solution. The individuals will then make use of the healthy lifestyle recommender solution for the entire study, i.e. a personalized, multi-level portfolio intervention will be tailored to the individual. The details of this intervention, including also nudges and gamification aspects will have to be developed during the project (WPs 2). Weekly phone-calls with participants from both groups will assure further adherence to the study.
Collected samples (month 0 and month 3) will be stored locally at University of Evora. All data and questionnaires will be collected by trained personnel, using RedCap platform. Data will be stored under a protected server, under the responsibility of Luxemburg Institute of Health, which is the leading institution of the project HealthyW8, under which this study is being developed. Individual data will be not linked to participants identification, since each participant will receive a code, at the beginning, answering all questionnaires and collecting all the samples under that identification (code). Only the researcher responsible for the study will have assess to the correspondence between identification and codes. This correspondence will be stored in an external drive, safely stored in the University of Evora and without being connected to internet.
The intervention will only require the healthy lifestyle recommender solution in form of an app. In addition, participants in the intervention arm will be able to access the Open Stakeholders Platform to access further information on healthy living. All data collected will be compiled in clinical report forms that will be generated by the University of Evora team. Saliva will be collected by trained researchers from the University of Evora. Regarding questionnaires, the investigators will use previous developed and validated questionnaires, such as the IPAQ questionnaire for physical activity or the SF-36 questionnaire for healthy lifestyle.
- Conditions
- Obese, Overweight
- Being tested
- HealthyW8 Digital Twin of healthy lifestyle recommendations
- Keywords
- Obesity, Overweight, Digital twin, Obesity prevention, 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.
HealthyW8 Digital Twin of healthy lifestyle recommendationsDevice
The applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis, but with a different purpose. Moreover, the type of digital solution that will be tested will put together different aspects that are not usually to see together in the same application. These different lifestyle aspects will be used for personalized recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Test of healthyW8 Digital Twin of healthy lifestyle recommendations | Experimental | Individuals will have access to a digital tool, putting together nutrition, physical activity and emotional aspects. Participant interaction with the tool, through registration collected or inputed by the individual will allow personalized recommendations. Receives: Device: HealthyW8 Digital Twin of healthy lifestyle 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, in order to determine the success of application of the healthy-lifestyle recommender solution to the target population (the young adults).
Measured: 3-month
Satisfaction relative to the digital solution
The satisfaction for the use of the digital solution will be assessed through questionnaires addressing the user-friendliness and limitation or problems encountered.
Scales will be used, where higher scores mean higher satisfaction.
Measured: 3 months
Secondary outcomes (8)
Anthropometry
Secondary outcomes (measured at the end of the 3-month period of the pilot):
Change of BMI, relatively to the beginning of the intervention.
Measured: 3-month
Fat Mass
Reduction of fat mass will be determined by measuring body composition through bio impedance at beginning and end of 3-month trial. The difference will allow to assess if fat mass decreased or increased, during this period.
Measured: 3-months
Blood Pressure
Blood pressure (systolic, diastolic) will be measured at the beginning and at the end of the 3-month trial.
Measured: 3-month
Salivary biomarkers
Saliva composition will be assessed for measuring concentration of C-reactive protein, salivary IgA, glucose and insulin. This will be done at the beginning and at the end of the 3-month trial, to assess changes during this period.
Measured: 3-month
Salivary markers of stress
Concentrations of salivary cortisol will be measured at the beginning and at the end of the 3-month period of the trial.
Measured: 3-month
Salivary Amylase
The enzymatic activity per unit of saliva volume will be assessed for amylase. This will be done in saliva collected at the beginning and at the end of 3-month trial.
Measured: 3-month
Physical activity
The level of physical-activity habits will be assessed using the IPAQ short form. The participants will be assessed at the beginning of the trial.
Measured: At the beginning of the study
Diet
The dietary habits will be assessed using a 24h-recall, applied for 3 different days, at the beginning of the trial. The results will allow to estimate the average amount of macro- and micronutrients daily ingested.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion20 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 ObeseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.
- 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
- NCT06943651
- Sponsor's protocol ID
- UEVHealthyW8YAdults
- Other IDs
- GA - 101080645
- Acronym
- HW8YAPilot
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will follow the General Data Protection Regulation (EU) 2016/679 of 27 April 2016 (known as the GDPR) and all subsequent texts replacing or supplementing this Regulation Before the start of the study, all subjects will be informed about the aim of the study, the study protocol, as well as risks/benefits. Only the researcher responsible for the study will have access to the correspondence between identification and the codes generated. This correspondence will be stored in a computer protected with password, not linked to internet and in a drive, stored in the University of Evora. All data (questionnaires, samples, etc.) will be identified with the participant code and not personal identification. Data will be presented treated, and no individual data, that could allow participant identification, will be public presented.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Healthy Lifestyle Behaviour Through Personalized Intervention Portfolios to Prevent and Control Obesity in Young Adults - A Pilot Study
- ClinicalTrials.gov ID
- NCT06943651
- Acronym / sponsor ID
- HW8YAPilot / UEVHealthyW8YAdults
- Conditions
- Obese, Overweight
- Keywords
- Obesity, Overweight, Digital twin, Obesity prevention, Lifestyle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 24 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 human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on young adults (age 18 to 25 y). 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. Young adults are at risk since in in this period of life most people start to be independent from their families, with the consequent decisions about their food and lifestyle choices. It is frequent that at this time an increase in irregularity of meals and unhealthy food choices, occurs, together with changes in physical activity habits and social or individual pressures. Because of this, it is essential to give tools to these individuals 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.
Detailed description
The applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis.
The investigators judge the risk for the participant as low, since only saliva will be collected which collection is totally non-invasive. The administered intervention is expected to be effective, based on the multi-level nature of the tools applied.
This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.
The investigators are aware of the potential influence of seasons and other longitudinal changes on the outcomes, however as the endpoints are rather motivation and adherence, the investigators deem the design as appropriate. Moreover, in case of salivary parameters, which can be more sensitive to this type of variation, the collection in three successive days, before and at the end of the trial (to be analysed as pooled samples) will minimize these potential effects.
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. The intervention will include collecting urinary and saliva samples, as well as measuring anthropometrics and collecting data (personal, socio-demographics, general health and well-being, physical activity and eating patterns, among other) via questionnaires.
The study duration will be 3 months from the official start to the end. Following a first interview to test participants eligibility, the investigators have compiled a list of exemplary endpoints in the following, providing an overview about the sampling frequency.
Young adults (age 18-25 y) will be recruited via university and local hospital (Hospital do Espirito Santo - Évora), with help from the researchers from the School of Health Sciences, by direct advertisement and by recommendation of Hospital dietitians. The run-in time of the study will be long enough to assure recruitment of the required number of persons. The participants will be followed up regularly by phone-calls from the team of the University of Évora (e.g. weekly), and via contact maintained through the developed healthy lifestyle recommender solution. Should recruitment be insufficient, additional advertisement via local newspapers will be carried out, and the run-in time be extended.
Participants will receive the developed healthy lifestyle recommender solution. The individuals will then make use of the healthy lifestyle recommender solution for the entire study, i.e. a personalized, multi-level portfolio intervention will be tailored to the individual. The details of this intervention, including also nudges and gamification aspects will have to be developed during the project (WPs 2). Weekly phone-calls with participants from both groups will assure further adherence to the study.
Collected samples (month 0 and month 3) will be stored locally at University of Evora. All data and questionnaires will be collected by trained personnel, using RedCap platform. Data will be stored under a protected server, under the responsibility of Luxemburg Institute of Health, which is the leading institution of the project HealthyW8, under which this study is being developed. Individual data will be not linked to participants identification, since each participant will receive a code, at the beginning, answering all questionnaires and collecting all the samples under that identification (code). Only the researcher responsible for the study will have assess to the correspondence between identification and codes. This correspondence will be stored in an external drive, safely stored in the University of Evora and without being connected to internet.
The intervention will only require the healthy lifestyle recommender solution in form of an app. In addition, participants in the intervention arm will be able to access the Open Stakeholders Platform to access further information on healthy living. All data collected will be compiled in clinical report forms that will be generated by the University of Evora team. Saliva will be collected by trained researchers from the University of Evora. Regarding questionnaires, the investigators will use previous developed and validated questionnaires, such as the IPAQ questionnaire for physical activity or the SF-36 questionnaire for healthy lifestyle.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.
| Arm | Type | Receives |
|---|---|---|
| Test of healthyW8 Digital Twin of healthy lifestyle recommendations | Experimental | Device: HealthyW8 Digital Twin of healthy lifestyle recommendationsIndividuals will have access to a digital tool, putting together nutrition, physical activity and emotional aspects. Participant interaction with the tool, through registration collected or inputed by the individual will allow personalized recommendations. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be young adult (age 18-25 y)
- To reside in Portugal
- To be overweight (BMI between 25-30 kg/m2)
- Women and men
Key exclusion criteria (3 listed)
- To have a 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 behavior 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 |
|---|---|---|
| HealthyW8 Digital Twin of healthy lifestyle recommendationsThe applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis, but with a different purpose. Moreover, the type of digital solution that will be tested will put together different aspects that are not usually to see together in the same application. These different lifestyle aspects will be used for personalized recommendations. | Device | Test of healthyW8 Digital Twin of healthy lifestyle recommendations |
Primary outcome
Adherence to digital tool
Time frame: 3-month
Adherence time to the lifestyle recommender solution, in order to determine the success of application of the healthy-lifestyle recommender solution to the target population (the young adults).
Satisfaction relative to the digital solution
Time frame: 3 months
The satisfaction for the use of the digital solution will be assessed through questionnaires addressing the user-friendliness and limitation or problems encountered. Scales will be used, where higher scores mean higher satisfaction.
8 secondary outcomes
Anthropometry
Time frame: 3-month
Fat Mass
Time frame: 3-months
Blood Pressure
Time frame: 3-month
Salivary biomarkers
Time frame: 3-month
Salivary markers of stress
Time frame: 3-month
Salivary Amylase
Time frame: 3-month
Physical activity
Time frame: At the beginning of the study
Diet
Time frame: 1 week
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 24 Apr 2025.
- Individual participant dataSharing planned: Yes. The investigators will follow the General Data Protection Regulation (EU) 2016/679 of 27 April 2016 (known as the GDPR) and all subsequent texts replacing or supplementing this Regulation Before the start of the study, all subjects will be informed about the aim of the study, the study protocol, as well as risks/benefits. Only the researcher responsible for the study will have access to the correspondence between identification and the codes generated. This correspondence will be stored in a computer protected with password, not linked to internet and in a drive, stored in the University of Evora. All data (questionnaires, samples, etc.) will be identified with the participant code and not personal identification. Data will be presented treated, and no individual data, that could allow participant identification, will be public presented.
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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 HealthyW8 Digital Twin of healthy lifestyle recommendations in people with Obese and Overweight, 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 24 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: 3-month). The study lists 2 primary outcomes in all. 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 24 Apr 2025.