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DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

ConditionsPre-obesityObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorSlovak Academy of Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

obesity (BMI 27-42 kg/m²)

capacity and willingness to use smartphone

capacity and willingness to use wearables

readiness to change (validated questionaire)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • technology driven self coaching

    Behavioral

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

  • Health coaching

    Behavioral

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

  • Peer coaching

    Behavioral

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

  • 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.

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: Self coaching (technology-assisted online intervention)Experimental treatment 1 intervention
Group B: Health coaching - online contact with professional coachExperimental treatment 1 intervention
Group C: Peer coaching - online contact with peer-coachExperimental treatment 1 intervention
Group D: Control group.Active comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Slovak Academy of Sciences

Lead sponsor

University Hospital Bratislava

Collaborator

Kempelen Institute of Inteligent Technologies

Collaborator

Source ClinicalTrials.gov
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