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| Name | Class |
|---|---|
| University Hospital Bratislava | OTHER |
| Kempelen Institute of Inteligent Technologies | UNKNOWN |
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The principal objective of the project is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self coaching (technology-assisted online intervention) | Experimental | Self coaching (technology-assisted online intervention) |
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| Health coaching - online contact with professional coach | Experimental | Health coaching - online contact with professional coach |
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| Peer coaching - online contact with peer-coach | Experimental | Peer coaching - online contact with peer-coach |
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| Control group. | Active Comparator | Wearable and basic information on healthy lifestyle will be provided, but any of the coaching strategies will be applied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| technology driven self coaching | Behavioral | subject will be provided with the technology driven lifestyle coaching based on the real time data from the wearables |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of wearable adoption/use | Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow. | 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. | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Habitual physical activity volume | wearable (Garmin vivosmart 5) provided daily step count | 24 months |
| Sleep quality | wearable (Garmin vivosmart 5) provided sleep quality parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Ukropcová, Prof., MD, PhD | Contact | 00421911643630 | barbara.ukropcova@savba.sk | |
| Alex Hucovicová, Dr. | Contact | ahucovicova@zhiva.sk |
| Name | Affiliation | Role |
|---|---|---|
| Jozef Ukropec, PhD, DSc | Biomedical Research Center Slovak Acad Sci | Principal Investigator |
| Zuzana Košutzka, A/prof., PhD | University Hospital Bratislava and Faculty of Medicine Comenius University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Obesity Management EASO, Biomedical Research Center SAS | Recruiting | Bratislava | Bratislava Region | 845 05 | Slovakia |
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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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomly assigned into one of the four intervention groups:
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| Health coaching | Behavioral | participants will be provided with the health coach (expert) driven lifestyle coaching based on the real-time data from the wearables |
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| Peer coaching | Behavioral | participants will be provided with the peer coach (expert) driven lifestyle coaching based on the real-time data from the wearables |
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| 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. |
|
| 24 months |
| Activity-related energy expenditure | Wearable (Garmin - vivosmart 5) provided daily active calories measure. | 24 months |
| Stress level | Wearable (GARMIN vivosmart 5) provided measure of daily stress level | 24 months |
| Emília Sičáková - Beblavá, Prof. Ing. PhD | University Hospital Bratislava and Faculty of Medicine Comenius University | Study Director |
| Miroslav Beblavý, A/prof. PhD | University Hospital Bratislava and Faculty of Medicine Comenius University | Study Director |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |