Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT07120802
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Better4All Personalized Intervention Pilot Study
Sponsor:
Harokopio University
Organization:
Study Overview
Official Title:
Better4All Personalized Intervention Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETTER4ALL
Brief 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. 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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: