ClinicalTrials.gg
RecruitingNCT06983431DIG4HEALTHUpdated May 21, 2025

DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

An interventional study of technology driven self coaching and Health coaching in Pre-obesity and Obesity, sponsored by Slovak Academy of Sciences. Recruiting at 1 site in Slovakia. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Obesity with a site in Slovakia — 9 open to participants now, 17 under way, 14 of them phase 3. Obesity · Slovakia.

Planned enrollment
25th of 34
320 · median 632
Started
2025
with 7 others
No phase
6 of 34
1 open now
Primary completion
2026-05
later than 2 of 16 live
Registered
22nd of 34
by date
Lead sponsor
5 of 34
Slovak Academy of Sciences

Among the 34 studies in Obesity with a site in Slovakia, this one is the 25th largest by planned enrollment, is one of 8 that started in 2025, is one of 6 with no phase, reaches primary completion later than 2 of the 16 other live ones, and was the 22nd registered.

By phase

34 studies; the count open now beside each. This study's row is marked.

Phase 324 · 7 open
No phasethis study6 · 1 open
Phase 12 · 1 open
Phase 22 · 0 open

By the year they started

First in 2006; this study’s year is marked. 8 started in 2025.

Size and results

Median enrollment 632 across the 34 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 34 studies in Obesity with a site in Slovakia, or all of them as a file.
02

Study 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.
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.

03

Conditions studied

  • Pre-obesity
  • Obesity

Keywords

  • wearable
  • behavioural intervention
  • habitual physical activity
  • quality of life
  • body weight and composition
  • sleep duration / eficiency
  • heart rate variability
04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • patients not adhering to the study protocol
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Self coaching (technology-assisted online intervention)

    Self coaching (technology-assisted online intervention)

    Behavioral: technology driven self coaching

  • Experimental
    Health coaching - online contact with professional coach

    Health coaching - online contact with professional coach

    Behavioral: Health coaching

  • Experimental
    Peer coaching - online contact with peer-coach

    Peer coaching - online contact with peer-coach

    Behavioral: Peer coaching

  • Active comparator
    Control group.

    Wearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied

    Behavioral: Active Control

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.

06

What researchers measure

Primary outcomes

  1. Rate of wearable adoption/use

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 24 months

Secondary outcomes

  1. Habitual physical activity volume

    wearable (Garmin vivosmart 5) provided daily step count

    Time frame: 24 months

  2. Sleep quality

    wearable (Garmin vivosmart 5) provided sleep quality parameter

    Time frame: 24 months

  3. Activity-related energy expenditure

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

    Time frame: 24 months

  4. Stress level

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

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Center for Obesity Management EASO, Biomedical Research Center SAS
    Bratislava, 845 05, Slovakia
    Recruiting
    • Barbara Ukropcova, Prof. MD, PhD · Contactbarbara.ukropcova@savba.sk · 00421911643630
    • Jozef Ukropec, PhD, DSc · Contactjozef.ukropec@savba.sk · 00421904059826
    • Petra Dubajová, mgr. · Sub investigator
    • Miriam Dojčárová, Mgr. · Sub investigator
    • Jana Kubíčková, Mgr. · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — Data will be provided in scientiffic publications. Anz data related to this study could be available upon reasonable request after their publication.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for May 2026, 12 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2025
First posted
May 21, 2025
StartActual
May 5, 2025
Primary completionEst.
May 5, 2026
CompletionEst.
Jun 30, 2026
Last update
May 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06983431
Lead sponsor
Slovak Academy of Sciences
Collaborators
University Hospital Bratislava Comenius University, Kempelen Institute of Inteligent Technologies
Responsible party
Jozef Ukropec (PhD, DSc, Slovak Academy of Sciences) — Principal investigator
First posted
May 21, 2025
Start date
May 5, 2025
Primary completion
May 5, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
May 21, 2025

Study contacts

Barbara Ukropcová, Prof., MD, PhD
Contact
barbara.ukropcova@savba.sk
00421911643630
Alex Hucovicová, Dr.
Contact
ahucovicova@zhiva.sk
Jozef Ukropec, PhD, DSc
principal investigator · Biomedical Research Center Slovak Acad Sci
Zuzana Košutzka, A/prof., PhD
study chair · University Hospital Bratislava and Faculty of Medicine Comenius University
Emília Sičáková - Beblavá, Prof. Ing. PhD
study director · University Hospital Bratislava and Faculty of Medicine Comenius University
Miroslav Beblavý, A/prof. PhD
study director · University Hospital Bratislava and Faculty of Medicine Comenius University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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