Better4All Personalized Intervention Pilot Study
A legfontosabb adatok
- Ki végzi
- Harokopio University
- Hol
- Nicosia (Ciprus)A helyszín megnézéseMég 6 másik országban, 6 helyszínen
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 490 fő, tervezett
- Kezdés
- 2025. jún. 1.
- Tervezett befejezés
- 2025. szept. 30.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- BETTER4U Mobile App and Wearable Use (End-User Group)
- BETTER4U Intervention Platform Testing (Implementer Group)
- A regiszteradat frissítve
- 2025. augusztus 13.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat 18-65 éves, átlagos lakossági felnőtteket keres, akik normál testsúlyúak vagy túlsúlyosak/elhízottak, és három hétig tudnak okosórát és Android-alkalmazást használni.
- Életkor
- 18-65 év
- Nem
- Mindkét nem jelentkezhet
- A betegség stádiuma
- Testtömegindex (BMI) 25 kg/m² vagy magasabb (túlsúly vagy elhízás), illetve BMI 18.5-24.9 kg/m² (normál testsúly)
A részvétel fő kizáró okai
- Terhes vagy szoptató nők
- Olyan testi vagy szellemi állapot, amely miatt nem tudja használni a viselhető eszközt vagy az alkalmazást
- Naponta vagy rendszeresen pálcikával étkezik
- Nincs kompatibilis Android okostelefonja, vagy műszaki okból nem tudja használni a viselhető eszközt
- Nem lakik a hét részt vevő ország egyikében sem
A regiszter feltételei, szó szerint
Mind a 12 feltétel megnézéseKevesebb
Ki vehet részt
- 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; 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
Ki nem vehet részt
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Helyszínek itt: Ciprus
Még 6 másik országban, 6 helyszínen
- University of Cyprus (Ucy)Nicosia, CiprusContact: Constantinos Deltas, ProfessorRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- End-users - General Population ParticipantsEgyéb csoport
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.
Kezelés: BETTER4U Mobile App and Wearable Use (End-User Group)
- Implementers - Healthcare ProfessionalsEgyéb csoport
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.
Kezelés: BETTER4U Intervention Platform Testing (Implementer Group)
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT07120802: ki vehet részt
- Publikációk
- Assessing Behavioral and Environmental Facets of Obesity Unobtrusively Utilizing Digital Tools: Introducing the BETTER4U Indicators.Obesity reviews : an official journal of the International Association for the Study of Obesity, 2026
- A regiszteradat frissítve
- 2025. augusztus 13.