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NCT Number: NCT07612852

Digital Engagement for Lifelong Health

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.

Recruiting

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Key information

Conditions

Life Style, Healthy Behavior Health Promotion Risk Reduction Risk Reduction Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR)

Messina, 98164, Italy

Location status: Recruiting

Location contact

Alessandro Guerrini

SUB_INVESTIGATOR

Alessia Valdesi

SUB_INVESTIGATOR

Barbara Caci

SUB_INVESTIGATOR

Chiara Urone

SUB_INVESTIGATOR

Concetta Polizzi

SUB_INVESTIGATOR

Flavia Altavilla

SUB_INVESTIGATOR

Gennaro Tartarisco

PRINCIPAL_INVESTIGATOR

Giorgia Bruschetta

SUB_INVESTIGATOR

Giulia Giordano

SUB_INVESTIGATOR

Irene Aprile

SUB_INVESTIGATOR

Marco Germanotta

SUB_INVESTIGATOR

Maria Cocchiara

SUB_INVESTIGATOR

Maria Valeria Maiorana

SUB_INVESTIGATOR

Mariacristina Siotto

SUB_INVESTIGATOR

Monia Andrea Papa

SUB_INVESTIGATOR

Renato Tino

SUB_INVESTIGATOR

Roberta Bruschetta

SUB_INVESTIGATOR

Serena Iacono Isidoro

CONTACT

[email protected]

+393281655820

Serena Iacono Isidoro

SUB_INVESTIGATOR

Simona Campisi

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Willingness to wear the wearable devices for continuous monitoring of physiological parameters.
  • Basic familiarity with mobile applications or willingness to receive training on their use.
  • Signed informed consent.

Exclusion criteria

  • 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.
  • Current use of medications that significantly affect the parameters being monitored (e.g., psychotropic drugs, beta-blockers).
  • Simultaneous participation in other clinical studies.
  • Logistical difficulties that prevent frequent interaction with the platform (e.g., lack of connection, unwillingness to attend periodic follow-ups).

Treatment and study plan

DELPHI Personalized Digital Prevention Platform

Other

the 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

Participants 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.

Primary outcomes

  1. World Health Organization Quality of Life (WHOQoL)

    Time frame: Baseline and 6 months

    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

  2. Depression, Anxiety, and Stress Symptoms (DASS-21)

    Time frame: Baseline and 6 months

    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+.

  3. Beck Depression Inventory-II (BDI-II)

    Time frame: Baseline and 6 months

    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

  4. International Physical Activity Levels (IPAQ)

    Time frame: Baseline and 6 months

    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.

  5. Prevention with Mediterranean Diet (PREDIMED)

    Time frame: Baseline and 6 months

    The Prevention with Mediterranean Diet (PREDIMED) questionnaire is a 14-item tool designed to assess adherence to the Mediterranean diet. Each item is scored as 0 or 1, and the total score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean dietary pattern.

Secondary outcomes

  1. Heart Rate

    Time frame: Continuously monitored from baseline to 6 months

    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

  2. Heart Rate Variability (HRV)

    Time frame: Continuously monitored from baseline to 6 months

    Nocturnal heart rate variability measured in milliseconds using wearable sensors.

  3. Body Weight

    Time frame: Baseline, every 2 weeks during the 6-month intervention period and 6 months

    Change in body weight measured in kilograms (kg).

  4. Body Mass Index (BMI)

    Time frame: Baseline and 6 months

    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

  5. Nutritional Intake

    Time frame: Weekly monitoring from baseline to 6 months

    Daily caloric, macronutrient, and micronutrient intake measured through in-app food diary records.

  6. Mental Well-Being Weekly Check-in Scores

    Time frame: Weekly from baseline to 6 months

    Weekly emotional well-being indicators measured through a 6-item Likert-scale in-app questionnaire assessing mood, calmness, energy, tension, and distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Gennaro Tartarisco

CONTACT

[email protected]

+393283377046

Maria Valeria Maiorana

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • Medilink s.r.l.
  • Universita degli Studi di Palermo

Registry information

Official study title

Digital Engagement for Lifelong Prevention and Health Improvement

Acronym: DELPHI

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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