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Life Style, HealthyDELPHINCT07612852

Digital Engagement for Lifelong Health

A study testing DELPHI Personalized Digital Prevention Platform in people with Life Style, Healthy and Risk Reduction, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
DELPHI Personalized Digital Prevention Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteItaly
Study dates
4 May 2026to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gennaro Tartarisco contact

+393283377046

gennaro.tartarisco@irib.cnr.it

Maria Valeria Maiorana contact

mariavaleria.maiorana@irib.cnr.it

Italy1 site, 1 recruiting

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

    Messina, 98164

    Serena Iacono Isidoro, +393281655820, serena.iaconoisidoro@irib.cnr.it

    Gennaro Tartarisco

    Recruiting

Other trials in Italy

About this study

Official title: Digital Engagement for Lifelong Prevention and Health Improvement

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.

Read more

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.

Being tested
DELPHI Personalized Digital Prevention Platform, Passive Digital Monitoring Control
Keywords
health, digitalization, prevention
Medical subject headings
Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DELPHI Personalized Digital Prevention PlatformOther

    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 ControlOther

    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.

Study groups in NCT07612852
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants 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.
Receives: Other: DELPHI Personalized Digital Prevention Platform
Control groupOtherParticipants will access a limited version of the application restricted to passive monitoring functions only, without personalized recommendations, adaptive content, or interactive notifications.
Receives: Other: Passive Digital Monitoring Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 6 months

  2. 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+.

    Measured: Baseline and 6 months

  3. 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

    Measured: Baseline and 6 months

  4. 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.

    Measured: Baseline and 6 months

  5. 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.

    Measured: Baseline and 6 months

Secondary outcomes (6)

  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

    Measured: Continuously monitored from baseline to 6 months

  2. Heart Rate Variability (HRV)

    Nocturnal heart rate variability measured in milliseconds using wearable sensors.

    Measured: Continuously monitored from baseline to 6 months

  3. Body Weight

    Change in body weight measured in kilograms (kg).

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

  4. 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

    Measured: Baseline and 6 months

  5. Nutritional Intake

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

    Measured: Weekly monitoring from baseline to 6 months

  6. Mental Well-Being Weekly Check-in Scores

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

    Measured: Weekly from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start4 May 2026
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612852
Sponsor's protocol ID
CNR-IRIB-PRO-2026-004
Acronym
DELPHI
Status last verified
May 2026
First submitted
19 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 36589760

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

    PubMed 11351599

  • 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

  • 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.

  • 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.

    PubMed 29343463

  • 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.

  • 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.

  • 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.

    PubMed 35612886

  • 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.

    PubMed 31405669

  • 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.

    PubMed 37571293

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

  • 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.

    PubMed 33239350

Questions about this trial

What is this clinical trial studying?

A study testing DELPHI Personalized Digital Prevention Platform in people with Life Style, Healthy and Risk Reduction, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gennaro Tartarisco (+393283377046, gennaro.tartarisco@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

World Health Organization Quality of Life (WHOQoL) (time frame: Baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07612852, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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