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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Alex Hucovicová, Dr. contact
Slovakia1 site, 1 recruiting
- 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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Self coaching (technology-assisted online intervention) | Experimental | Self coaching (technology-assisted online intervention) Receives: Behavioral: technology driven self coaching |
| Health coaching - online contact with professional coach | Experimental | Health coaching - online contact with professional coach Receives: Behavioral: Health coaching |
| Peer coaching - online contact with peer-coach | Experimental | Peer coaching - online contact with peer-coach Receives: Behavioral: Peer coaching |
| Control group. | Active comparator | Wearable 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.
Rate of wearable adoption/use
Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (4)
Habitual physical activity volume
wearable (Garmin vivosmart 5) provided daily step count
Measured: 24 months
Sleep quality
wearable (Garmin vivosmart 5) provided sleep quality parameter
Measured: 24 months
Activity-related energy expenditure
Wearable (Garmin - vivosmart 5) provided daily active calories measure.
Measured: 24 months
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.
- First posted21 May 2025
- Study start5 May 2025
- Primary completion5 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-obesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- University Hospital Bratislava, Kempelen Institute of Inteligent Technologies
- Responsible party
- Principal investigator, Jozef Ukropec, Slovak Academy of Sciences
- Investigators
- Jozef Ukropec, PhD, DSc, Principal investigator, Biomedical Research Center Slovak Acad SciZuzana Košutzka, A/prof., PhD, Study chair, University Hospital Bratislava and Faculty of Medicine Comenius UniversityEmília Sičáková - Beblavá, Prof. Ing. PhD, Study director, University Hospital Bratislava and Faculty of Medicine Comenius UniversityMiroslav Beblavý, A/prof. PhD, Study director, University Hospital Bratislava and Faculty of Medicine Comenius University
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT IN AT-RISK GROUPS TO IMPROVE HEALTH OUTCOMES THROUGH INTEGRATION OF TECHNOLOGICAL AND SOCIAL INNOVATION
- ClinicalTrials.gov ID
- NCT06983431
- Acronym / sponsor ID
- DIG4HEALTH / 09I05-03-V02-00060
- Conditions
- Pre-obesity, Obesity
- Keywords
- wearable, behavioural intervention, habitual physical activity, quality of life, body weight and composition, sleep duration / eficiency, heart rate variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- University Hospital Bratislava, Kempelen Institute of Inteligent Technologies
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self coaching (technology-assisted online intervention) | Experimental | Behavioral: technology driven self coachingSelf coaching (technology-assisted online intervention) |
| Health coaching - online contact with professional coach | Experimental | Behavioral: Health coachingHealth coaching - online contact with professional coach |
| Peer coaching - online contact with peer-coach | Experimental | Behavioral: Peer coachingPeer coaching - online contact with peer-coach |
| Control group. | Active comparator | Behavioral: Active ControlWearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- obesity (BMI 27-42 kg/m²)
- capacity and willingness to use smartphone
- capacity and willingness to use wearables
- readiness to change (validated questionaire)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| technology driven self coachingsubject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables | Behavioural | Self coaching (technology-assisted online intervention) |
| Health coachingparticipants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables | Behavioural | Health coaching - online contact with professional coach |
| Peer coachingparticipants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables | Behavioural | Peer coaching - online contact with peer-coach |
| Active Controlparticipants 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. | Behavioural | Control group. |
Primary outcome
Rate of wearable adoption/use
Time frame: 24 months
Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.
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.
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.
4 secondary outcomes
Habitual physical activity volume
Time frame: 24 months
Sleep quality
Time frame: 24 months
Activity-related energy expenditure
Time frame: 24 months
Stress level
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. Data will be provided in scientiffic publications. Anz data related to this study could be available upon reasonable request after their publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Hucovicová, Dr. contact
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
1 site in 1 country: see every site and its status.
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.