TrialGlobe

Clinical trial

DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT

Recruiting now · Not applicable · 1 countries · Registry ID NCT06983431

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionPre-obesity, Obesity

Full registry criteria

Inclusion Criteria: * obesity (BMI 27-42 kg/m²) * capacity and willingness to use smartphone * capacity and willingness to use wearables * readiness to change (validated questionaire) 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 informed consent * patients not adhering to the study protocol

Treatments and study arms

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.

Primary outcomes

Rate of wearable adoption/use24 months

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

Effect of intervention on Quality of life24 months

Quality of life will be provided by the validated questionaire filled in at baseline and after completing the study.

Effect of intervention on health24 months

Effects of intervention for health state will be provided by the questionaire administered at the baseline and after completing the study.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Obesity Management EASO, Biomedical Research Center SAS🌐 Bratislava, Bratislava Region, Slovakia
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Barbara Ukropcova, Prof. MD, PhDContact
Email · Call 00421911643630
Jozef Ukropec, PhD, DScContact
Email · Call 00421904059826
Petra Dubajová, mgr.Sub Investigator