Actively Recruiting
Digital Engagement for Lifelong Prevention and Health Improvement A Pilot Randomized Study Using Personalized Digital Health Technology
Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2026-05-29
200
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Istituto per la Ricerca e l'Innovazione Biomedica
Lead Sponsor
F
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the DELPHI project, a digital platform designed to promote well-being and prevent chronic non-communicable diseases in healthy adults aged 18 to 65. This pilot study aims to test the platform's usability, feasibility, and acceptance in real-world settings, while exploring its effects on health and lifestyle without confirming outcomes. The study also includes special assessments for mental well-being and virtual reality modules for biomechanical risk evaluation in certain worker groups. Participants will be randomly assigned to one of two groups: an experimental group using the full DELPHI platform with personalized recommendations, adaptive content, and continuous feedback, or a control group using a basic version limited to passive monitoring. The intervention includes wearable sensors, mobile app data collection, AI-generated lifestyle advice, multimedia exercises, mindfulness practices, and educational content. The study lasts up to 12 months per participant. During the study, participants will wear Fitbit Inspire 3 devices and complete digital questionnaires to collect data on physical activity, sleep, nutrition, and mental health. Researchers will monitor physiological indicators continuously and assess outcomes such as quality of life, depression, anxiety, stress, physical activity levels, and adherence to the Mediterranean diet at baseline and six months. Weekly mental well-being scores and body measurements are also tracked. The study ensures strong data protection and privacy compliance throughout.
CONDITIONS
Brief Title
Digital Engagement for Lifelong Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Apparent good general health status confirmed by medical history and self-assessment
- Ability to understand study information and provide informed consent
- Availability and motivation to participate for the entire 12-month study duration
- Access to a smartphone compatible with the DELPHI application
- Willingness to wear wearable devices for continuous physiological monitoring
- Basic familiarity with mobile apps or willingness to receive training
- Signed informed consent
You will not qualify if you...
- Presence of severe chronic diseases in active phase (e.g., cancer, cardiovascular, neurological diseases)
- Acute or unstable conditions compromising participation
- Current pregnancy
- Diagnosed major cognitive or psychiatric disorders hindering understanding or adherence
- Current use of medications significantly affecting monitored parameters (e.g., psychotropic drugs, beta-blockers)
- Participation in other clinical studies
- Logistical difficulties preventing frequent platform interaction (e.g., lack of connection, unwillingness for follow-ups)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or virtual)
Duration - 6 months
Participants use either the full personalized DELPHI digital prevention platform with wearable sensors, mobile app-based data collection, and adaptive lifestyle recommendations, or a limited version of the app for passive digital monitoring without personalized feedback.
Weekly digital check-ins and continuous wearable monitoring throughout the 6-month intervention period
Duration - 6 months after treatment
Participants complete final assessments of quality of life, mental health, physical activity, nutrition, and body measurements at the end of the study period.
1 final visit (in-person or virtual) at 6 months post-intervention
Trial Site Locations
Total: 1 location
1
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR)
Messina, Italy, 98164
Actively Recruiting
Research Team
G
Gennaro Tartarisco
M
Maria Valeria Maiorana
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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