Obesity PreventionBETTER4ALLNCT07120802
Better4All Personalized Intervention Pilot Study
A study testing BETTER4U Mobile App and Wearable Use (End-User Group) and BETTER4U Intervention Platform Testing (Implementer Group) in people with Obesity Prevention, run by Harokopio University at 7 sites in 7 countries.
Trial summary
The BETTER4U project (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) is funded by the European Union (EU) and involves an international consortium consisting of 28 partners across Europe, Israel, and Australia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- BETTER4U Mobile App and Wearable Use (End-User Group) and BETTER4U Intervention Platform Testing (Implementer Group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 1 Jun 2025to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Participants aged 18-65 years to represent the adult general population.
- Body Mass Index (BMI):
- Overweight or obesity group: BMI ≥ 25 kg/m².
- Normal weight group: BMI 18.5-24.9 kg/m².
- Technology Use:
- Willingness and ability to use wearable devices and an Android mobile application for the duration of the study.
Show all 12Show fewer
- Owning a smartphone device with the Android operating system.
- Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon.
- Language Proficiency: Ability to read and understand the language in which the mobile app and study materials are provided.
- Consent: Willing to provide informed consent to participate in the study.
- Residency: Must be a resident of one of the seven participating countries.
- Availability: Able to participate for the full three-week duration of the study and comply with the study protocol.
Who cannot join
- Health Conditions: Pregnant or breastfeeding women, as they might have different lifestyle behaviours or health needs.
- Physical Limitations: Any physical or mental condition that would prevent the participant from using the wearable device or mobile application as intended.
- Eating utensil technique: eating food with chopsticks on a daily or regular basis.
- Technical Incompatibility: Individuals who do not own a compatible smartphone or are unable to use the provided wearable devices for technical reasons.
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 7 countries
Cyprus1 site, 1 recruiting
- Recruiting
University of Cyprus (Ucy)
Nicosia, 2109
Constantinos Deltas, Professor
France1 site, 1 recruiting
- Recruiting
Universite Lyon 1 Claude Bernard (Ucbl)
Villeurbanne, 69622 CEDEX
Julie-Anne Nazare
Greece1 site, 1 recruiting
- Recruiting
Harokopio University
Athens, Aticca, 17676
Yannis Manios, Professor, 2109549156 ext. +30, manios@hua.gr
Eva Karaglani, 2109549340 ext. +30, ekaragl@hua.gr
Poland1 site, 1 recruiting
- Recruiting
Uniwersytet Swps (Swps)
Wroclaw, 53-238
Aleksandra L, Professor
Portugal1 site, 1 recruiting
- Recruiting
Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss)
Lisbon, 1649-016
Ana Isabel Rito, Professor
Spain1 site, 1 recruiting
- Recruiting
Universidad de Navarra (Unav)
Pamplona, Navarre, 31008
Mai Bes-Rastrollo, Professor
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Huddinge, 141 83
Ioannis Ioakeimidis
About this study
The BETTER4U project (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) is funded by the European Union (EU) and involves an international consortium consisting of 28 partners across Europe, Israel, and Australia. The project started in November 2023 and will run until October 2027. The main aim of BETTER4U is to improve weight management through a tailor-made intervention, the "BETTER4ALL personalized intervention", using modern monitoring tools and artificial intelligence (AI), including machine learning (ML) practices.
In the context of the BETTER4U project, the present Pilot Study aims to a) evaluate the usability, feasibility and acceptability of the BETTER4U mobile application ("BETTER4U App") and Intervention Platform that will be used to monitor and collect data from participants in the BETTER4ALL personalized intervention (randomized controlled trial; RCT) and b) collect data to evaluate and improve the BETTER4U causal AI models for the prevention of weight gain, before deploying them at large scale, as well as test and identify the optimal ways of delivering the AI-based interventions to the participants. The study will be conducted in seven sites in Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden.
Read more
The BETTER4All Pilot Study will be a longitudinal, correlational, observational study, including a total of n=490 participants, equally distributed among the seven sites (i.e. n=70 per site). Specifically, n=60 (± 3-5) "general population" participants (henceforth: "end-users" of the wearables and the BETTER4U App) and n=10 (± 3-5) healthcare or other types of providers (henceforth: potential "implementers" of the BETTER4U intervention) will constitute each site's sample.
The study will involve the following two components: a) the administration of the wearables (smartwatches) to the "end-users" and their registration to and training on the BETTER4U App, to be used for a total duration of three weeks (21 days). During this period, their lifestyle behaviours (i.e. "BETTER4U Core Behavioural Indicators - BCBIs", such as eating occasions, physical activity, sedentary time, sleep etc.) and "living environment indicators - LEIs"; (e.g. access to parks in your area, distance from your home to your work place etc.) will be recorded daily, either in an automated way via the wearables or self-reported by the end-users through the App; and b) the registration to and training on the BETTER4U Intervention Platform of the "implementers" for a total duration of one week (7 days), during which they will be asked to test the platform's functionalities using synthetic data. The implementers will also be provided with the wearables and the App (similarly to the end-users) for one week only to allow collection of additional data that will help verify the accuracy of the algorithms in the gathered data from the wearables/monitoring tools regarding BCBIs and LEIs.
Overall, the outcomes and the findings of the Pilot Study will be used to further refine, optimize, and adjust the tools for the BETTER4ALL RCT, according to the feedback received by both end-users' and implementers' perspectives.
Read the detailed description
The BETTER4All Pilot Study is a multicenter, longitudinal, observational study designed to assess the usability, feasibility, and acceptability of the BETTER4U App and BETTER4U Intervention Platform, both of which integrate real-time behavioral monitoring and artificial intelligence (AI)-driven decision support tools. Conducted in seven European countries (Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden), the study includes approximately 490 adult participants split into two groups: (a) "end-users" from the general population, who will use wearable devices and the mobile App for 21 days, and (b) "implementers," healthcare professionals who will test the intervention platform for 7 days using synthetic and self-recorded data.
The BETTER4U system employs Bluetooth Low Energy (BLE) smartwatches for passive data collection, including accelerometer signals, heart rate variability, sleep structure, and geolocation data. Data from the wearables and smartphone sensors are processed using AI and machine learning algorithms to derive behavioral indicators such as physical activity, eating, sleep patterns (termed BETTER4U Core Behavioral Indicators - BCBIs), and contextual environmental factors (Living Environment Indicators - LEIs). These indicators are calculated both locally and on secure servers via structured data pipelines, ensuring privacy and GDPR compliance.
Data collection comprises three sources: (1) passively collected wearable/App data, (2) online questionnaires via RedCap (e.g., IPAQ, GAD-2, PHQ-2, EQ-5D-5L, PSQI, Mini-EAT), and (3) "ground truth" data logged by implementers to validate algorithmic outputs. Engagement metrics, such as app usage duration and feature interaction frequency, are also automatically recorded. Feedback on usability and feasibility is collected via validated tools, including the System Usability Scale (SUS), MAUQ, AIM, IAM, and FIM.
The primary technical aim is to verify and refine the causal AI models developed in earlier project phases (WP5), ensuring the system is optimized for personalized intervention delivery in the upcoming BETTER4ALL randomized controlled trial (WP7).
- Conditions
- Obesity Prevention
- Being tested
- BETTER4U Mobile App and Wearable Use (End-User Group), BETTER4U Intervention Platform Testing (Implementer Group)
- Keywords
- weight management, polygenic risk score, artificial intelligence, personalized intervention, obesity, randomized controlled trial
- Medical subject headings
- Genetic Risk Score, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETTER4U Mobile App and Wearable Use (End-User Group)Behavioural
Participants from the general population ("end-users") will use a smartwatch and the BETTER4U mobile app for 21 days. The app passively collects data (physical activity, sleep, eating behaviors, environment), while participants may self-report certain behaviors. The goal is to assess the usability, feasibility, and acceptability of the tools and to collect real-world behavioral data for refining AI models.
BETTER4U Intervention Platform Testing (Implementer Group)Behavioural
Healthcare professionals and other potential implementers will test the BETTER4U Intervention Platform and mobile app for 7 days. They will assess system usability, complete synthetic case simulations, and provide daily feedback via Google Forms. They also wear the smartwatch and use the app for data validation purposes. The goal is to evaluate platform usability and collect ground-truth data for validating AI algorithm outputs.
| Study group | Role | What they receive |
|---|---|---|
| End-users - General Population Participants | Other | Adults from the general population (aged 18- 65 years, with normal weight or overweight/obesity) who will use the BETTER4U mobile application and a wearable smartwatch for 21 days. During this period, lifestyle behaviors and living environment indicators will be recorded daily, either automatically via the wearable or through self-reports via the app. Receives: Behavioral: BETTER4U Mobile App and Wearable Use (End-User Group) |
| Implementers - Healthcare Professionals | Other | Healthcare professionals (e.g., medical doctors, dietitians/nutritionists, psychologists, nurses) who will use the BETTER4U Intervention Platform, mobile application, and wearable smartwatch for 7 days. During this period, they will interact daily with the Intervention Platform using synthetic data to evaluate its functionalities and usability. Additionally, they will wear the smartwatch and use the app to record lifestyle behavior and living environment indicators (LEIs). They will provide structured "growth truth" data (e.g., transportation mode, activity levels, sleep quality) to validate the accuracy of the AI algorithms. Their feedback will help optimize their intervention delivery system and AI-based tools before large-scale deployment. Receives: Behavioral: BETTER4U Intervention Platform Testing (Implementer Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS) Score - End-Users
Usability of the BETTER4U App as reported by end-users using the validated SUS questionnaire (10 items, total score 0-100).
Measured: Day 21 (end of participation period for end-users)
System Usability Scale (SUS) Score - Implementers
Usability of the BETTER4U App and Intervention Platform as reported by implementers using the validated SUS questionnaire. Unit of Measure: Mean SUS score (0-100).
Measured: Day 7 (end of participation period for implementers
Acceptability of Intervention Measure (AIM) Score - End-Users
Acceptability of the BETTER4U App rated by end-users using the AIM (4 items, 5-point Likert scale). Unit of Measure: Mean AIM score (1-5)
Measured: Day 21
AIM Score - Implementers
Acceptability of the BETTER4U Intervention Platform rated by implementers using AIM. Mean AIM score (1-5)
Measured: Day 7
Feasibility of Intervention Measure (FIM) Score - End-Users
Feasibility of the BETTER4U App as perceived by end-users. Mean FIM score (1-5)
Measured: Day 21
FIM Score - Implementers
Feasibility of the BETTER4U Intervention Platform as perceived by implementers. Mean FIM score (1-5).
Measured: Day 7
Intervention Appropriateness Measure (IAM) Score - End-Users
Appropriateness of the BETTER4U App as rated by end-users. Mean IAM score (1-5).
Measured: Day 21
IAM Score - Implementers
Appropriateness of the BETTER4U Intervention Platform as rated by implementers.Mean IAM score (1-5)
Measured: Day 7
Secondary outcomes (4)
mHealth App Usability Questionnaire (MAUQ) Score - Implementers
Usability of the Intervention Platform among implementers, assessed with the adapted MAUQ.
Measured: Day 7
App Usage - Number of Logins (End-Users)
App engagement as measured by the number of logins during the study. Mean number of logins per participant
Measured: Day 21
App Usage - Time Spent per Module (End-Users)
Engagement measured by the average time (in minutes) spent per module within the BETTER4U App. Mean time (minutes) per module.
Measured: Day 21
Thematic Analysis of Open Feedback (Qualitative)
Qualitative analysis of open-ended feedback provided by participants regarding the usability and content of the BETTER4U tools.
Measured: Day 21 (end-users) / Day 7 (implementers)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal, correlational, observational pilot study
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra, University of Cyprus, Karolinska Institutet, University SWPS, Claude Bernard University, CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS (CEIDSS)
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Professor, Principal investigator, Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120802
- Sponsor's protocol ID
- B4U101080117
- Acronym
- BETTER4ALL
- Status last verified
- May 2025
- First submitted
- 20 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Episkopou C, Aletras D, Kita A, Luszczynska A, Kafyra M, Karaglani E, Manios Y, Bes-Rastrollo M, Ek A, Ioakeimidis I, Kalafati IP, Rito A, Kyriacou A, Dougkas A, Nazare JA, Seconda L, Santorelli G, Fanos V, Silventoinen K, Lehtimaki T, Dedoussis GV, Delopoulos A; of the BETTER4U consortium, Project Coordinator George Dedoussis. Assessing Behavioral and Environmental Facets of Obesity Unobtrusively Utilizing Digital Tools: Introducing the BETTER4U Indicators. Obes Rev. 2026 Oct 15:e70242. doi: 10.1111/obr.70242. Online ahead of print.
PubMed 42880872
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better4All Personalized Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT07120802
- Acronym / sponsor ID
- BETTER4ALL / B4U101080117
- Conditions
- Obesity Prevention
- Keywords
- weight management, polygenic risk score, artificial intelligence, personalized intervention, obesity, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- University of Navarra, University of Cyprus, Karolinska Institutet, University SWPS, Claude Bernard University, CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS (CEIDSS)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Aug 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.
The BETTER4U project (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) is funded by the European Union (EU) and involves an international consortium consisting of 28 partners across Europe, Israel, and Australia. The project started in November 2023 and will run until October 2027. The main aim of BETTER4U is to improve weight management through a tailor-made intervention, the "BETTER4ALL personalized intervention", using modern monitoring tools and artificial intelligence (AI), including machine learning (ML) practices.
In the context of the BETTER4U project, the present Pilot Study aims to a) evaluate the usability, feasibility and acceptability of the BETTER4U mobile application ("BETTER4U App") and Intervention Platform that will be used to monitor and collect data from participants in the BETTER4ALL personalized intervention (randomized controlled trial; RCT) and b) collect data to evaluate and improve the BETTER4U causal AI models for the prevention of weight gain, before deploying them at large scale, as well as test and identify the optimal ways of delivering the AI-based interventions to the participants. The study will be conducted in seven sites in Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden.
The BETTER4All Pilot Study will be a longitudinal, correlational, observational study, including a total of n=490 participants, equally distributed among the seven sites (i.e. n=70 per site). Specifically, n=60 (± 3-5) "general population" participants (henceforth: "end-users" of the wearables and the BETTER4U App) and n=10 (± 3-5) healthcare or other types of providers (henceforth: potential "implementers" of the BETTER4U intervention) will constitute each site's sample.
The study will involve the following two components: a) the administration of the wearables (smartwatches) to the "end-users" and their registration to and training on the BETTER4U App, to be used for a total duration of three weeks (21 days). During this period, their lifestyle behaviours (i.e. "BETTER4U Core Behavioural Indicators - BCBIs", such as eating occasions, physical activity, sedentary time, sleep etc.) and "living environment indicators - LEIs"; (e.g. access to parks in your area, distance from your home to your work place etc.) will be recorded daily, either in an automated way via the wearables or self-reported by the end-users through the App; and b) the registration to and training on the BETTER4U Intervention Platform of the "implementers" for a total duration of one week (7 days), during which they will be asked to test the platform's functionalities using synthetic data. The implementers will also be provided with the wearables and the App (similarly to the end-users) for one week only to allow collection of additional data that will help verify the accuracy of the algorithms in the gathered data from the wearables/monitoring tools regarding BCBIs and LEIs.
Overall, the outcomes and the findings of the Pilot Study will be used to further refine, optimize, and adjust the tools for the BETTER4ALL RCT, according to the feedback received by both end-users' and implementers' perspectives.
Detailed description
The BETTER4All Pilot Study is a multicenter, longitudinal, observational study designed to assess the usability, feasibility, and acceptability of the BETTER4U App and BETTER4U Intervention Platform, both of which integrate real-time behavioral monitoring and artificial intelligence (AI)-driven decision support tools. Conducted in seven European countries (Cyprus, France, Greece, Poland, Portugal, Spain, and Sweden), the study includes approximately 490 adult participants split into two groups: (a) "end-users" from the general population, who will use wearable devices and the mobile App for 21 days, and (b) "implementers," healthcare professionals who will test the intervention platform for 7 days using synthetic and self-recorded data.
The BETTER4U system employs Bluetooth Low Energy (BLE) smartwatches for passive data collection, including accelerometer signals, heart rate variability, sleep structure, and geolocation data. Data from the wearables and smartphone sensors are processed using AI and machine learning algorithms to derive behavioral indicators such as physical activity, eating, sleep patterns (termed BETTER4U Core Behavioral Indicators - BCBIs), and contextual environmental factors (Living Environment Indicators - LEIs). These indicators are calculated both locally and on secure servers via structured data pipelines, ensuring privacy and GDPR compliance.
Data collection comprises three sources: (1) passively collected wearable/App data, (2) online questionnaires via RedCap (e.g., IPAQ, GAD-2, PHQ-2, EQ-5D-5L, PSQI, Mini-EAT), and (3) "ground truth" data logged by implementers to validate algorithmic outputs. Engagement metrics, such as app usage duration and feature interaction frequency, are also automatically recorded. Feedback on usability and feasibility is collected via validated tools, including the System Usability Scale (SUS), MAUQ, AIM, IAM, and FIM.
The primary technical aim is to verify and refine the causal AI models developed in earlier project phases (WP5), ensuring the system is optimized for personalized intervention delivery in the upcoming BETTER4ALL randomized controlled trial (WP7).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal, correlational, observational pilot study
| Arm | Type | Receives |
|---|---|---|
| End-users - General Population Participants | Other | Behavioral: BETTER4U Mobile App and Wearable Use (End-User Group)Adults from the general population (aged 18- 65 years, with normal weight or overweight/obesity) who will use the BETTER4U mobile application and a wearable smartwatch for 21 days. During this period, lifestyle behaviors and living environment indicators will be recorded daily, either automatically via the wearable or through self-reports via the app. |
| Implementers - Healthcare Professionals | Other | Behavioral: BETTER4U Intervention Platform Testing (Implementer Group)Healthcare professionals (e.g., medical doctors, dietitians/nutritionists, psychologists, nurses) who will use the BETTER4U Intervention Platform, mobile application, and wearable smartwatch for 7 days. During this period, they will interact daily with the Intervention Platform using synthetic data to evaluate its functionalities and usability. Additionally, they will wear the smartwatch and use the app to record lifestyle behavior and living environment indicators (LEIs). They will provide structured "growth truth" data (e.g., transportation mode, activity levels, sleep quality) to validate the accuracy of the AI algorithms. Their feedback will help optimize their intervention delivery system and AI-based tools before large-scale deployment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: Participants aged 18-65 years to represent the adult general population.
- Body Mass Index (BMI):
- Technology Use:
- Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon.
- Language Proficiency: Ability to read and understand the language in which the mobile app and study materials are provided.
Key exclusion criteria (4 listed)
- Health Conditions: Pregnant or breastfeeding women, as they might have different lifestyle behaviours or health needs.
- Physical Limitations: Any physical or mental condition that would prevent the participant from using the wearable device or mobile application as intended.
- Eating utensil technique: eating food with chopsticks on a daily or regular basis.
- Technical Incompatibility: Individuals who do not own a compatible smartphone or are unable to use the provided wearable devices for technical reasons.
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 |
|---|---|---|
| BETTER4U Mobile App and Wearable Use (End-User Group)Participants from the general population ("end-users") will use a smartwatch and the BETTER4U mobile app for 21 days. The app passively collects data (physical activity, sleep, eating behaviors, environment), while participants may self-report certain behaviors. The goal is to assess the usability, feasibility, and acceptability of the tools and to collect real-world behavioral data for refining AI models. | Behavioural | End-users - General Population Participants |
| BETTER4U Intervention Platform Testing (Implementer Group)Healthcare professionals and other potential implementers will test the BETTER4U Intervention Platform and mobile app for 7 days. They will assess system usability, complete synthetic case simulations, and provide daily feedback via Google Forms. They also wear the smartwatch and use the app for data validation purposes. The goal is to evaluate platform usability and collect ground-truth data for validating AI algorithm outputs. | Behavioural | Implementers - Healthcare Professionals |
Primary outcome
System Usability Scale (SUS) Score - End-Users
Time frame: Day 21 (end of participation period for end-users)
Usability of the BETTER4U App as reported by end-users using the validated SUS questionnaire (10 items, total score 0-100).
System Usability Scale (SUS) Score - Implementers
Time frame: Day 7 (end of participation period for implementers
Usability of the BETTER4U App and Intervention Platform as reported by implementers using the validated SUS questionnaire. Unit of Measure: Mean SUS score (0-100).
Acceptability of Intervention Measure (AIM) Score - End-Users
Time frame: Day 21
Acceptability of the BETTER4U App rated by end-users using the AIM (4 items, 5-point Likert scale). Unit of Measure: Mean AIM score (1-5)
AIM Score - Implementers
Time frame: Day 7
Acceptability of the BETTER4U Intervention Platform rated by implementers using AIM. Mean AIM score (1-5)
Feasibility of Intervention Measure (FIM) Score - End-Users
Time frame: Day 21
Feasibility of the BETTER4U App as perceived by end-users. Mean FIM score (1-5)
FIM Score - Implementers
Time frame: Day 7
Feasibility of the BETTER4U Intervention Platform as perceived by implementers. Mean FIM score (1-5).
Intervention Appropriateness Measure (IAM) Score - End-Users
Time frame: Day 21
Appropriateness of the BETTER4U App as rated by end-users. Mean IAM score (1-5).
IAM Score - Implementers
Time frame: Day 7
Appropriateness of the BETTER4U Intervention Platform as rated by implementers.Mean IAM score (1-5)
4 secondary outcomes
mHealth App Usability Questionnaire (MAUQ) Score - Implementers
Time frame: Day 7
App Usage - Number of Logins (End-Users)
Time frame: Day 21
App Usage - Time Spent per Module (End-Users)
Time frame: Day 21
Thematic Analysis of Open Feedback (Qualitative)
Time frame: Day 21 (end-users) / Day 7 (implementers)
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 13 Aug 2025.
- Derived from this study: PubMed 42880872Episkopou C, Aletras D, Kita A, Luszczynska A, Kafyra M, Karaglani E, Manios Y, Bes-Rastrollo M, Ek A, Ioakeimidis I, Kalafati IP, Rito A, Kyriacou A, Dougkas A, Nazare JA, Seconda L, Santorelli G, Fanos V, Silventoinen K, Lehtimaki T, Dedoussis GV, Delopoulos A; of the BETTER4U consortium, Project Coordinator George Dedoussis. Assessing Behavioral and Environmental Facets of Obesity Unobtrusively Utilizing Digital Tools: Introducing the BETTER4U Indicators. Obes Rev. 2026 Oct 15:e70242. doi: 10.1111/obr.70242. Online ahead of print.
- Better4U website linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity Prevention
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Recruiting
ENLIGHT Trial: ESG With Fundal Mucosal Ablation
Obesity, Obesity (Body Mass Index >30 kg/m2)
Recruiting
PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
Prediabetic State, Life Style
Enrolling by invitation
EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
Prevention of Childhood Obesity, Community Health Education
Active, not recruiting
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Obesity, Gestational Diabetes
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.
Yannis Manios, Professor principal investigator
Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETTER4U Mobile App and Wearable Use (End-User Group) and BETTER4U Intervention Platform Testing (Implementer Group) in people with Obesity Prevention, run by Harokopio University at 7 sites in 7 countries.
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 12 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Cyprus, France, Greece, Poland, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yannis Manios, Professor (2109549156 ext. +30, manios@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) Score - End-Users (time frame: Day 21 (end of participation period for end-users)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120802, which also lists 1 linked publication.
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 13 Aug 2025.