Digital Engagement for Lifelong Health

NCT07612852 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2026-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Life Style, Healthy; Risk Reduction; Health Promotion

Keywords

health; digitalization; prevention

Outcome Measures

Primary Outcomes (5)

• 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

  Baseline and 6 months

• 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+.

  Baseline and 6 months

• 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

  Baseline and 6 months

• 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.

  Baseline and 6 months

• Prevention with Mediterranean Diet (PREDIMED)

  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.

  Baseline and 6 months

Secondary Outcomes (6)

• Heart Rate

  Continuously monitored from baseline to 6 months

• Heart Rate Variability (HRV)

  Continuously monitored from baseline to 6 months

• Body Weight

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

• Body Mass Index (BMI)

  Baseline and 6 months

• Nutritional Intake

  Weekly monitoring from baseline to 6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will use the full version of the DELPHI platform, including wearable sensors, mobile app-based data collection, personalized recommendations generated through artificial intelligence algorithms, multimedia content (physical exercises, mindfulness activities, and educational videos), as well as interactive notifications and feedback.

Other: DELPHI Personalized Digital Prevention Platform

Control group

OTHER

Participants will access a limited version of the application restricted to passive monitoring functions only, without personalized recommendations, adaptive content, or interactive notifications.

Other: Passive Digital Monitoring Control

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Universita degli Studi di Palermo: collaborator
• Medilink s.r.l.: collaborator

Study Sites (1)

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

Messina, 98164, Italy

RECRUITING

Related Publications (13)

• Moon J, Ju BK. Wearable sensors for healthcare of industrial workers: a scoping review. Electronics. 2024;13(19):3849. doi:10.3390/electronics13193849.

  BACKGROUND

• Gray R, Indraratna P, Lovell N, Ooi SY. Digital health technology in the prevention of heart failure and coronary artery disease. Cardiovasc Digit Health J. 2022 Dec 15;3(6 Suppl):S9-S16. doi: 10.1016/j.cvdhj.2022.09.002. eCollection 2022 Dec.

  PMID: 36589760 BACKGROUND

• Takahashi S, Yamamoto T. [apoE receptor 2]. Nihon Rinsho. 2001 Feb;59 Suppl 2:325-8. No abstract available. Japanese.

  PMID: 11351599 BACKGROUND

• Brough P, Timms C, Chan XW, et al. Work-life balance: definitions, causes, and consequences. In: Theorell T, ed. Handbook of Socioeconomic Determinants of Occupational Health. Springer; 2020. doi:10.1007/978-3-030-05031-3_20-1

  BACKGROUND

• Zangger M, Wälchli C, Stefenelli U, et al. The use of mobile health applications for the prevention of non-communicable diseases. Health Technol. 2021; 11: 585-593. doi:10.1007/s12553-021-00536-8.

  BACKGROUND

• Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873.

  PMID: 29343463 BACKGROUND

• Choe EK, Klasnja P, Pratt W. mHealth and applications. In: Shortliffe EH, Cimino JJ, eds. Biomedical Informatics. Springer; 2021. doi:10.1007/978-3-030-58721-5_19.

  BACKGROUND

• Eurofound. Psychosocial risks to workers' well-being: lessons from the COVID-19 pandemic. European Working Conditions Telephone Survey 2021 series. Publications Office of the European Union; 2023.

  BACKGROUND

• Jakob R, Harperink S, Rudolf AM, Fleisch E, Haug S, Mair JL, Salamanca-Sanabria A, Kowatsch T. Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review. J Med Internet Res. 2022 May 25;24(5):e35371. doi: 10.2196/35371.

  PMID: 35612886 BACKGROUND

• Debon R, Coleone JD, Bellei EA, De Marchi ACB. Mobile health applications for chronic diseases: A systematic review of features for lifestyle improvement. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2507-2512. doi: 10.1016/j.dsx.2019.07.016. Epub 2019 Jul 9.

  PMID: 31405669 BACKGROUND

• Laffond A, Rivera-Picon C, Rodriguez-Munoz PM, Juarez-Vela R, Ruiz de Vinaspre-Hernandez R, Navas-Echazarreta N, Sanchez-Gonzalez JL. Mediterranean Diet for Primary and Secondary Prevention of Cardiovascular Disease and Mortality: An Updated Systematic Review. Nutrients. 2023 Jul 28;15(15):3356. doi: 10.3390/nu15153356.

  PMID: 37571293 BACKGROUND

• WHO global status report on alcohol and health and treatment of substance use disorders. Geneva: World Health Organization; 2024

  BACKGROUND

• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  PMID: 33239350 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gennaro Tartarisco

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gennaro Tartarisco

CONTACT

+393283377046; gennaro.tartarisco@irib.cnr.it

Maria Valeria Maiorana

CONTACT

mariavaleria.maiorana@irib.cnr.it

Study Design

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

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)