Better4All Personalized Intervention Pilot Study

NCT07120802 | Recruiting

• 1 other identifier: B4U101080117
• Study Type: interventional
• Target: 490
• Locations: 7 countries
• Sites: 7

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.

Conditions

Obesity Prevention

Keywords

weight management; polygenic risk score; artificial intelligence; personalized intervention; obesity; randomized controlled trial

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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)

  Day 21

• AIM Score - Implementers

  Acceptability of the BETTER4U Intervention Platform rated by implementers using AIM. Mean AIM score (1-5)

  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)

  Day 21

• FIM Score - Implementers

  Feasibility of the BETTER4U Intervention Platform as perceived by implementers. Mean FIM score (1-5).

  Day 7

• Intervention Appropriateness Measure (IAM) Score - End-Users

  Appropriateness of the BETTER4U App as rated by end-users. Mean IAM score (1-5).

  Day 21

• IAM Score - Implementers

  Appropriateness of the BETTER4U Intervention Platform as rated by implementers.Mean IAM score (1-5)

  Day 7

Secondary Outcomes (4)

• mHealth App Usability Questionnaire (MAUQ) Score - Implementers

  Day 7

• App Usage - Number of Logins (End-Users)

  Day 21

• App Usage - Time Spent per Module (End-Users)

  Day 21

• Thematic Analysis of Open Feedback (Qualitative)

  Day 21 (end-users) / Day 7 (implementers)

Study Arms (2)

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.

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.

Behavioral: BETTER4U Intervention Platform Testing (Implementer Group)

Interventions

BETTER4U Mobile App and Wearable Use (End-User Group) BEHAVIORAL

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.

End-users - General Population Participants

BETTER4U Intervention Platform Testing (Implementer Group) BEHAVIORAL

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.

Implementers - Healthcare Professionals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• University of Navarra: collaborator
• University of Cyprus: collaborator
• Karolinska Institutet: collaborator
• University SWPS: collaborator
• Claude Bernard University: collaborator
• CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS (CEIDSS): collaborator

Study Sites (7)

University of Cyprus (Ucy)

Nicosia, 2109, Cyprus

RECRUITING

Universite Lyon 1 Claude Bernard (Ucbl)

Villeurbanne, 69622 CEDEX, France

RECRUITING

Harokopio University

Athens, Aticca, 17676, Greece

RECRUITING

Uniwersytet Swps (Swps)

Wroclaw, 53-238, Poland

RECRUITING

Centro de Estudos E Investigacao Em Dinamicas Sociais E Saude Associacao Sem Fins Lucrativos (Ceidss)

Lisbon, 1649-016, Portugal

RECRUITING

Universidad de Navarra (Unav)

Pamplona, Navarre, 31008, Spain

RECRUITING

Karolinska Institutet

Huddinge, 141 83, Sweden

RECRUITING

Related Links

• Better4U website link

MeSH Terms

Conditions

Genetic Risk Score; Obesity

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Yannis Manios, Professor

  Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannis Manios, Professor

CONTACT

2109549156; manios@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Longitudinal, correlational, observational pilot study

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 13, 2025
• Study Start: June 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-05

Locations

GR (1); PT (1); ES (1); FR (1); CY (1); SE (1); PL (1)