Digital Engagement for Lifelong Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto per la Ricerca e l'Innovazione Biomedica
About this trial
The DELPHI project (Digital Engagement for Lifelong Prevention and Health Improvement) aims to develop, implement, and validate an advanced digital platform for promoting well-being and personalized prevention of chronic non-communicable diseases in healthy adults. By integrating wearable sensors, artificial intelligence, federated learning, and the Human Digital Twin (HDT) paradigm, the DELPHI platform is designed to collect, analyze, and interpret multidimensional data in order to deliver dynamic and personalized recommendations for healthy lifestyles.
The study adopts a multicenter, randomized controlled pilot design, with a maximum duration of 12 months per participant. A total of 200 healthy adults aged 18-65 will be recruited in Southern Italy (Sicily, Campania, and Basilicata) and randomly assigned to either: (1) an experimental group using the full DELPHI platform, including personalized recommendations, adaptive content, and continuous feedback; or (2) a control group using a basic version limited to passive monitoring.
As a non-clinical primary prevention pilot study, DELPHI aims to assess the operational feasibility, usability, and acceptability of the platform in real-world settings, while also exploring preliminary signals of impact on health and lifestyle domains without confirmatory purposes. Secondary objectives include monitoring physiological indicators, adherence to the app and wearable devices, and evaluating the feasibility of implementing the platform in workplace environments.
Data collection will rely on wearable devices, digital questionnaires, and behavioral analysis, with strong safeguards for personal data protection in compliance with GDPR and advanced security approaches such as federated learning and encryption.
Specific subgroups, including workers from the Fondazione Don Carlo Gnocchi (FDG) as well as university staff and students, will be involved in targeted assessments related to mental well-being and distress. In addition, workers from the FDG will test a virtual reality module designed to evaluate biomechanical overload risks during manual handling activities in simulated environments. These additional physiological and virtual reality components are exploratory and non-diagnostic.
Overall, DELPHI seeks to provide a solid foundation for the adoption of predictive and personalized models in digital health, contributing to the development of a sustainable and accessible prevention ecosystem, particularly in Southern Italy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Apparent good general health status, confirmed by medical history and initial self-assessment.
Ability to understand the study information and provide informed consent.
Availability and motivation to participate for the entire duration of the study (12 months).
Access to a smartphone compatible with the DELPHI application.
Disqualifiers
Presence of severe chronic diseases in active phase (e.g., oncological, cardiovascular, or neurological diseases).
Acute or unstable conditions that could compromise participation in the protocol.
Current pregnancy.
Diagnosed major cognitive or psychiatric disorders that hinder understanding of or adherence to the protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
DELPHI Personalized Digital Prevention Platform
Other interventionthe full version of the DELPHI digital platform, designed to support personalized primary prevention and health promotion. The intervention includes continuous monitoring through wearable sensors (Fitbit Inspire 3), mobile app-based data collection, and adaptive lifestyle recommendations generated by artificial intelligence algorithms within a Human Digital Twin framework. Participants will receive personalized feedback and notifications related to physical activity, sleep, nutrition, hydration, stress management, and psychological well-being. The platform also delivers multimedia educational content, including guided exercises, mindfulness and breathing practices, wellness educational videos, and behavioral micro-actions. Data collected through wearable devices, digital questionnaires, and behavioral monitoring are used to dynamically tailor recommendations and preventive strategies throughout the study period.
Passive Digital Monitoring Control
Other interventionParticipants assigned to the control group will use a limited version of the DELPHI application restricted to passive monitoring functions. The application will collect data from wearable devices and questionnaires related to physical activity, sleep, nutrition, and well-being, but participants will not receive personalized recommendations, adaptive educational content, interactive feedback, or behavioral notifications. The control condition is intended to provide observational digital monitoring only, without active preventive intervention or AI-based personalization.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
World Health Organization Quality of Life (WHOQoL)
The World Health Organization Quality of Life (WHOQoL) is a questionnaire used to assess quality of life.The WHOQOL-BREF, its short form, includes 26 items and evaluates four domains: physical health, psychological health, social relationships, and environment. It does not generate a single total score; instead, it provides separate domain scores, with higher values indicating better quality of life
Time frame
Baseline and 6 months2
Depression, Anxiety, and Stress Symptoms (DASS-21)
The Depression, Anxiety and Stress Scales-21 (DASS-21) is a 21-item self-report instrument designed to assess the severity of depression, anxiety, and stress symptoms. It consists of three subscales, each containing 7 items, and uses a 4-point response format. The scale provides separate scores for depression, anxiety, and stress rather than a single diagnostic score. * Depression: normal 0-9, mild 10-13, moderate 14-20, severe 21-27, extremely severe 28+. * Anxiety: normal 0-7, mild 8-9, moderate 10-14, severe 15-19, extremely severe 20+. * Stress: normal 0-14, mild 15-18, moderate 19-25, severe 26-33, extremely severe 34+.
Time frame
Baseline and 6 months3
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument designed to measure the severity of depressive symptoms over the past two weeks. Each item is rated on a 0 to 3 scale, and the total score ranges from 0 to 63. The total BDI-II score is calculated by summing all 21 items, giving a range from 0 to 63. Common interpretive cut-offs are: minimal depression 0-13, mild 14-19, moderate 20-28, and severe 29-63
Time frame
Baseline and 6 months4
International Physical Activity Levels (IPAQ)
The International Physical Activity Questionnaire (IPAQ) is a self-report instrument designed to assess physical activity levels over the previous 7 days. It provides both a categorical score, classifying individuals as low, moderate, or high active, and a continuous score expressed as MET-minutes per week. * Categorical score: low, moderate, or high physical activity. * Continuous score: total physical activity expressed as MET-minutes/week. The continuous score is calculated using standard MET values: * Walking = 3.3 METs. * Moderate activity = 4.0 METs. * Vigorous activity = 8.0 METs.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Heart Rate
Average heart rate measured through wearable sensors in beats per minute (bpm). Normal resting heart rate in adults is commonly about 60 to 100 bpm
Time frame
Continuously monitored from baseline to 6 months2
Heart Rate Variability (HRV)
Nocturnal heart rate variability measured in milliseconds using wearable sensors.
Time frame
Continuously monitored from baseline to 6 months3
Body Weight
Change in body weight measured in kilograms (kg).
Time frame
Baseline, every 2 weeks during the 6-month intervention period and 6 months4
Body Mass Index (BMI)
adults, BMI is usually interpreted as follows: Underweight: below 18.5 Healthy weight: 18.5 to 24.9 Overweight: 25.0 to 29.9 Obesity: 30.0 or above
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto per la Ricerca e l'Innovazione Biomedica
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator
Universita degli Studi di Palermo
Collaborator
Medilink s.r.l.
Collaborator
Source ClinicalTrials.gov