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Pre-obesityDIG4HEALTHNCT06983431

DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

A study testing technology driven self coaching, Health coaching and Peer coaching in people with Pre-obesity and Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.

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 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… Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Pre-obesity, Obesity
What is being tested?
technology driven self coaching, Health coaching and Peer coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteSlovakia
Study dates
5 May 2025to 30 Jun 2026
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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

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

Barbara Ukropcová, Prof., MD, PhD contact

00421911643630

barbara.ukropcova@savba.sk

Alex Hucovicová, Dr. contact

ahucovicova@zhiva.sk

Slovakia1 site, 1 recruiting
  • Center for Obesity Management EASO, Biomedical Research Center SAS

    Bratislava, Bratislava Region, 845 05

    Barbara Ukropcova, Prof. MD, PhD, 00421911643630, barbara.ukropcova@savba.sk

    Jozef Ukropec, PhD, DSc, 00421904059826, jozef.ukropec@savba.sk

    Recruiting

Other trials in Slovakia

About this study

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

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.
Read the 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.

Conditions
Pre-obesity, Obesity
Being tested
technology driven self coaching, Health coaching, Peer coaching, Active Control
Keywords
wearable, behavioural intervention, habitual physical activity, quality of life, body weight and composition, sleep duration / eficiency, heart rate variability
Medical subject headings
Obesity, Body Weight

What participants receive

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

  • technology driven self coachingBehavioural

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

  • Health coachingBehavioural

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

  • Peer coachingBehavioural

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

  • Active ControlBehavioural

    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.

Study groups in NCT06983431
Study groupRoleWhat they receive
Self coaching (technology-assisted online intervention)ExperimentalSelf coaching (technology-assisted online intervention)
Receives: Behavioral: technology driven self coaching
Health coaching - online contact with professional coachExperimentalHealth coaching - online contact with professional coach
Receives: Behavioral: Health coaching
Peer coaching - online contact with peer-coachExperimentalPeer coaching - online contact with peer-coach
Receives: Behavioral: Peer coaching
Control group.Active comparatorWearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied
Receives: Behavioral: Active Control

What is being measured

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

  1. Rate of wearable adoption/use

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

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

Secondary outcomes (4)
  1. Habitual physical activity volume

    wearable (Garmin vivosmart 5) provided daily step count

    Measured: 24 months

  2. Sleep quality

    wearable (Garmin vivosmart 5) provided sleep quality parameter

    Measured: 24 months

  3. Activity-related energy expenditure

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

    Measured: 24 months

  4. Stress level

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

    Measured: 24 months

Timeline

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

  1. First posted21 May 2025
  2. Study start5 May 2025
  3. Primary completion5 May 2026 (estimated)
  4. Study completion30 Jun 2026 (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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06983431
Sponsor's protocol ID
09I05-03-V02-00060
Acronym
DIG4HEALTH
Status last verified
Apr 2025
First submitted
29 Apr 2025
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be provided in scientiffic publications. Anz data related to this study could be available upon reasonable request after their publication.

Questions about this trial

What is this clinical trial studying?

A study testing technology driven self coaching, Health coaching and Peer coaching in people with Pre-obesity and Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.

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 4 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 21 May 2025. 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 Slovakia. 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 Barbara Ukropcová, Prof., MD, PhD (00421911643630, barbara.ukropcova@savba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of wearable adoption/use (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 May 2025.

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