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DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT IN AT-RISK GROUPS TO IMPROVE HEALTH OUTCOMES THROUGH INTEGRATION OF TECHNOLOGICAL AND SOCIAL INNOVATION

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06983431
Acronym
DIG4HEALTH
Enrollment
320
Registered
2025-05-21
Start date
2025-05-05
Completion date
2026-06-30
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pre-obesity

Keywords

wearable, behavioural intervention, habitual physical activity, quality of life, body weight and composition, sleep duration / eficiency, heart rate variability

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.

Detailed description

This research project is aimed at leveraging digital tools to personalise preventive healthcare interventions for at-risk populations in ways that address the above-mentioned challenges. At risk populations, in the context of this project, generally means: Younger to middle aged (aged 30-50) sedentary individuals with (pre)obesity expressing behavioural, clinical, biochemical and anamnestic indicators of increased risk for accelerated decline of cardio-metabolic and cognitive health. Primary outcomes will be the rate of wearable adoption/use, individualised behavioural change persistence and elicited health benefit Secondary outcomes will include step count, activity of medium & vigorous intensity, sleep duration/efficiency, heart rate, quality of life, body weight, body composition, blood pressure, and level of fitness as determined by the wearable or validated questionaires available on the landing page. Participants will be randomly assigned into one of the three intervention groups and a control group. The three intervention groups: 1. Self-health coaching will be conducted using wearable and technology provided nudges allowing personalised technology-assisted real-time feedback. With this approach, on-line intervention with minimal human resource costs and high technology involvement with a potential to deliver sustainable and cost-effective behavioural change to a large at-risk population will be tested. This intervention approx. 80 participants will be examined for the duration of 14 weeks. Long term follow up examination is envisaged, but it is beyond this study duration and will be supported by subsequent funding. 2. Health coaching (online health-coach community based) intervention will be based on applying wearable providing the most effective impact on health-related outcomes as evidenced in the exploratory study in combination with the online supervised intervention by the professional health-coach in an online group (community setting). Within this intervention the efficacy of an online supervised health coaching applied in community settings will be tested. Professional health coaching strategy using wearable-related outcomes will be provided as a golden standard of the behavioural intervention with proven efficiency. This intervention will be tested on approx. 80 participants for the duration of 14 weeks. 3. Peer coaching: Peers will be identified from the study population based on their response to specific community challenges. Natural leader characteristics will be deciphered from knowledge provided by the past supervised community-based behavioural interventions at BMC SAS and the other open sources subjected to AI driven prediction modelling. Within this intervention the efficacy of an online health coaching led by peers will be tested in an online community based setting. Peer-based health coach will lead participants through health training based on the protocol defining minimal coaching criteria but imposing no limits to any communication activities including the real-time access to the wearable-provided outcomes. The intervention will be tested on approx. 80 participants for the duration of 14 weeks. Long term follow up examination is envisaged, but it is beyond this study duration and will be supported by subsequent funding. 4. Control group participants will receive health coaching - related information enabling self-health coaching in a printed form during initial phenotyping visit and a wearable. The control group will consist of approx. 50 participants and observation period will be 14 weeks. Long term follow up examination is envisaged, but it is beyond this study duration and will be supported by subsequent funding. Innovative strategies to employ AI and machine learning will be tested to support their meaningful (providing real health benefits) and cost effective use.

Interventions

BEHAVIORALtechnology driven self coaching

subject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables

BEHAVIORALHealth coaching

participants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables

BEHAVIORALPeer coaching

participants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables

BEHAVIORALActive Control

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.

Sponsors

University Hospital Bratislava Comenius University
CollaboratorUNKNOWN
Kempelen Institute of Inteligent Technologies
CollaboratorUNKNOWN
Slovak Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Participants will be randomly assigned into one of the four intervention groups: 1. Self coaching (technology-assisted online intervention) 2. Health coaching - online contact with professional coach 3. Peer coaching - online contact with peer-coach 4. Control group.

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* obesity (BMI 27-42 kg/m²) * capacity and willingness to use smartphone * capacity and willingness to use wearables * readiness to change (validated questionaire)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of wearable adoption/use24 monthsRate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.
Effect of intervention on Quality of life24 monthsQuality of life will be provided by the validated questionaire filled in at baseline and after completing the study.
Effect of intervention on health24 monthsEffects of intervention for health state will be provided by the questionaire administered at the baseline and after completing the study.

Secondary

MeasureTime frameDescription
Habitual physical activity volume24 monthswearable (Garmin vivosmart 5) provided daily step count
Stress level24 monthsWearable (GARMIN vivosmart 5) provided measure of daily stress level
Sleep quality24 monthswearable (Garmin vivosmart 5) provided sleep quality parameter
Activity-related energy expenditure24 monthsWearable (Garmin - vivosmart 5) provided daily active calories measure.

Countries

Slovakia

Contacts

Primary ContactBarbara Ukropcová, Prof., MD, PhD
barbara.ukropcova@savba.sk00421911643630
Backup ContactAlex Hucovicová, Dr.
ahucovicova@zhiva.sk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026