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Digital Engagement for Lifelong Health (DELPHI)

25. Mai 2026 aktualisiert von: Gennaro Tartarisco, Istituto per la Ricerca e l'Innovazione Biomedica

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.

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Italien
      • Messina, Italien, 98164
        • Rekrutierung
        • Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR)
        • Unterermittler:
          • Roberta Bruschetta
        • Unterermittler:
          • Simona Campisi
        • Unterermittler:
          • Maria Valeria Maiorana
        • Hauptermittler:
          • Gennaro Tartarisco
        • Unterermittler:
          • Serena Iacono Isidoro
        • Unterermittler:
          • Concetta Polizzi
        • Unterermittler:
          • Renato Tino
        • Unterermittler:
          • Marco Germanotta
        • Kontakt:
        • Unterermittler:
          • Irene Aprile
        • Unterermittler:
          • Mariacristina Siotto
        • Unterermittler:
          • Alessandro Guerrini
        • Unterermittler:
          • Monia Andrea Papa
        • Unterermittler:
          • Giorgia Bruschetta
        • Unterermittler:
          • Barbara Caci
        • Unterermittler:
          • Maria Cocchiara
        • Unterermittler:
          • Flavia Altavilla
        • Unterermittler:
          • Alessia Valdesi
        • Unterermittler:
          • Chiara Urone
        • Unterermittler:
          • Giulia Giordano

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental group
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.
Sonstiges: DELPHI Personalized Digital Prevention Platform

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.
Sonstiges: Control group
Participants will access a limited version of the application restricted to passive monitoring functions only, without personalized recommendations, adaptive content, or interactive notifications.
Sonstiges: Passive Digital Monitoring Control

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
World Health Organization Quality of Life (WHOQoL)
Zeitfenster: 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
Baseline and 6 months
Depression, Anxiety, and Stress Symptoms (DASS-21)
Zeitfenster: 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+.
Baseline and 6 months
Beck Depression Inventory-II (BDI-II)
Zeitfenster: 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
Baseline and 6 months
International Physical Activity Levels (IPAQ)
Zeitfenster: 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.
Baseline and 6 months
Prevention with Mediterranean Diet (PREDIMED)
Zeitfenster: 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.
Baseline and 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Heart Rate
Zeitfenster: 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
Continuously monitored from baseline to 6 months
Heart Rate Variability (HRV)
Zeitfenster: Continuously monitored from baseline to 6 months
Nocturnal heart rate variability measured in milliseconds using wearable sensors.
Continuously monitored from baseline to 6 months
Body Weight
Zeitfenster: Baseline, every 2 weeks during the 6-month intervention period and 6 months
Change in body weight measured in kilograms (kg).
Baseline, every 2 weeks during the 6-month intervention period and 6 months
Body Mass Index (BMI)
Zeitfenster: 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
Baseline and 6 months
Nutritional Intake
Zeitfenster: Weekly monitoring from baseline to 6 months
Daily caloric, macronutrient, and micronutrient intake measured through in-app food diary records.
Weekly monitoring from baseline to 6 months
Mental Well-Being Weekly Check-in Scores
Zeitfenster: 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.
Weekly from baseline to 6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Mitarbeiter

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

Ermittler

  • Hauptermittler: Gennaro Tartarisco, Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Mai 2026

Primärer Abschluss (Geschätzt)

30. November 2026

Studienabschluss (Geschätzt)

30. März 2027

Studienanmeldedaten

Zuerst eingereicht

19. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CNR-IRIB-PRO-2026-004

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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