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NCT Number: NCT06983431

DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

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.

Recruiting

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Obesity Management EASO, Biomedical Research Center SAS

Bratislava, Bratislava Region, 845 05, Slovakia

Location status: Recruiting

Location contact

Barbara Ukropcova, Prof. MD, PhD

CONTACT

[email protected]

00421911643630

Jana Kubíčková, Mgr.

SUB_INVESTIGATOR

Jozef Ukropec, PhD, DSc

CONTACT

[email protected]

00421904059826

Miriam Dojčárová, Mgr.

SUB_INVESTIGATOR

Petra Dubajová, mgr.

SUB_INVESTIGATOR

About this study

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:

  • 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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

technology driven self coaching

Behavioral

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

Health Coaching

Behavioral

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

Peer Coaching

Behavioral

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

Active Control

Behavioral

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.

Primary outcomes

  1. Rate of wearable adoption/use

    Time frame: 24 months

    Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.

  2. Effect of intervention on Quality of life

    Time frame: 24 months

    Quality of life will be provided by the validated questionaire filled in at baseline and after completing the study.

  3. Effect of intervention on health

    Time frame: 24 months

    Effects of intervention for health state will be provided by the questionaire administered at the baseline and after completing the study.

Secondary outcomes

  1. Habitual physical activity volume

    Time frame: 24 months

    wearable (Garmin vivosmart 5) provided daily step count

  2. Sleep quality

    Time frame: 24 months

    wearable (Garmin vivosmart 5) provided sleep quality parameter

  3. Activity-related energy expenditure

    Time frame: 24 months

    Wearable (Garmin - vivosmart 5) provided daily active calories measure.

  4. Stress level

    Time frame: 24 months

    Wearable (GARMIN vivosmart 5) provided measure of daily stress level

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Hucovicová, Dr.

CONTACT

[email protected]

Barbara Ukropcová, Prof., MD, PhD

CONTACT

[email protected]

00421911643630

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Collaborators

  • Kempelen Institute of Inteligent Technologies
  • University Hospital Bratislava

Registry information

Official study title

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

Acronym: DIG4HEALTH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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