DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT
DIG4HEALTH
1 other identifier
interventional
320
1 country
1
Brief Summary
The principal objective of the project is:
- to bring together academic and business research organisations in a joint partnership integrating technological and social innovation,
- in order to develop proof-of-concept of a scalable and cost effective personalised digital health program for (pre)obesity patients,
- by integrating, in an ethical manner, adaptive AI components aimed at personalisation of the program as well as its cost management,
- with the ultimate objective to support sustained behavioural change leading to adoption and internalisation of healthy lifestyle choices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMay 21, 2025
April 1, 2025
1 year
April 29, 2025
May 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of wearable adoption/use
Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.
24 months
Effect of intervention on Quality of life
Quality of life will be provided by the validated questionaire filled in at baseline and after completing the study.
24 months
Effect of intervention on health
Effects of intervention for health state will be provided by the questionaire administered at the baseline and after completing the study.
24 months
Secondary Outcomes (4)
Habitual physical activity volume
24 months
Sleep quality
24 months
Activity-related energy expenditure
24 months
Stress level
24 months
Study Arms (4)
Self coaching (technology-assisted online intervention)
EXPERIMENTALSelf coaching (technology-assisted online intervention)
Health coaching - online contact with professional coach
EXPERIMENTALHealth coaching - online contact with professional coach
Peer coaching - online contact with peer-coach
EXPERIMENTALPeer coaching - online contact with peer-coach
Control group.
ACTIVE COMPARATORWearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied
Interventions
subject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables
participants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables
participants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables
participants will be provided with the wearable, but not exposed to any of the coaching strategies. Real-time data provided by the wearable will be available to them.
Eligibility Criteria
You may qualify if:
- obesity (BMI 27-42 kg/m²)
- capacity and willingness to use smartphone
- capacity and willingness to use wearables
- readiness to change (validated questionaire)
You may not qualify if:
- diseases that prevent participation in the program, or insufficiently controlled diseases, or terminal-stage illnesses
- excessive alcohol consumption or a history of other addictions
- patients currently participating in a weight-loss program (commercial, medically supervised, or a research study)
- patients using anti-obesity medications who are in the dosage adjustment phase within the last four weeks
- patients who are not mentally, physically, or technologically capable of participating
- patients who are unable to provide informed consent
- patients not adhering to the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Obesity Management EASO, Biomedical Research Center SAS
Bratislava, Bratislava Region, 845 05, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jozef Ukropec, PhD, DSc
Biomedical Research Center Slovak Acad Sci
- STUDY CHAIR
Zuzana Košutzka, A/prof., PhD
University Hospital Bratislava and Faculty of Medicine Comenius University
- STUDY DIRECTOR
Emília Sičáková - Beblavá, Prof. Ing. PhD
University Hospital Bratislava and Faculty of Medicine Comenius University
- STUDY DIRECTOR
Miroslav Beblavý, A/prof. PhD
University Hospital Bratislava and Faculty of Medicine Comenius University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, DSc
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 21, 2025
Study Start
May 5, 2025
Primary Completion
May 5, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 21, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
Data will be provided in scientiffic publications. Anz data related to this study could be available upon reasonable request after their publication.