Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2025-05-05
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Self coaching (technology-assisted online intervention)
Self coaching (technology-assisted online intervention)
technology driven self coaching
subject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables
Health coaching - online contact with professional coach
Health coaching - online contact with professional coach
Health coaching
participants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables
Peer coaching - online contact with peer-coach
Peer coaching - online contact with peer-coach
Peer coaching
participants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables
Control group.
Wearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied
Active 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.
Interventions
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technology driven self coaching
subject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables
Health coaching
participants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables
Peer coaching
participants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables
Active 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.
Eligibility Criteria
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Inclusion Criteria
* capacity and willingness to use smartphone
* capacity and willingness to use wearables
* readiness to change (validated questionaire)
Exclusion Criteria
* 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
25 Years
65 Years
ALL
No
Sponsors
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University Hospital Bratislava Comenius University
UNKNOWN
Kempelen Institute of Inteligent Technologies
UNKNOWN
Slovak Academy of Sciences
OTHER_GOV
Responsible Party
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Jozef Ukropec
PhD, DSc
Principal Investigators
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Jozef Ukropec, PhD, DSc
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Center Slovak Acad Sci
Zuzana Košutzka, A/prof., PhD
Role: STUDY_CHAIR
University Hospital Bratislava and Faculty of Medicine Comenius University
Emília Sičáková - Beblavá, Prof. Ing. PhD
Role: STUDY_DIRECTOR
University Hospital Bratislava and Faculty of Medicine Comenius University
Miroslav Beblavý, A/prof. PhD
Role: STUDY_DIRECTOR
University Hospital Bratislava and Faculty of Medicine Comenius University
Locations
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Center for Obesity Management EASO, Biomedical Research Center SAS
Bratislava, Bratislava Region, Slovakia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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09I05-03-V02-00060
Identifier Type: -
Identifier Source: org_study_id
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