Personalized digital health program for managing obesity
DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT IN AT-RISK GROUPS TO IMPROVE HEALTH OUTCOMES THROUGH INTEGRATION OF TECHNOLOGICAL AND SOCIAL INNOVATION
This study is testing a new digital health program designed to help people with obesity or pre-obesity make healthier lifestyle choices and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Slovak Academy of Sciences Government |
| Locations | 1 site (Bratislava, Bratislava Region) |
| Trial ID | NCT06983431 on ClinicalTrials.gov |
What this trial studies
This project aims to develop a scalable and cost-effective digital health program tailored for individuals with pre-obesity and obesity. By integrating adaptive AI components, the program will provide personalized interventions to promote sustained behavioral changes and healthier lifestyle choices. Participants will be randomly assigned to different intervention groups, including self-health coaching using wearables, to assess the effectiveness of technology-driven support in improving health outcomes. The study will measure various health metrics, including physical activity, quality of life, and body composition.
Who should consider this trial
Good fit: Ideal candidates are younger to middle-aged individuals (30-50 years) with a BMI between 27-42 kg/m² who are willing to use smartphones and wearables.
Not a fit: Patients with terminal illnesses, uncontrolled diseases, or those currently engaged in other weight-loss programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve health outcomes and quality of life for individuals struggling with obesity.
How similar studies have performed: Other studies utilizing technology-driven behavioral interventions have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bratislava, Bratislava Region
- Center for Obesity Management EASO, Biomedical Research Center SAS — Bratislava, Bratislava Region, Slovakia (Recruiting)
Study contacts
- Principal investigator: Jozef Ukropec, PhD, DSc — Biomedical Research Center Slovak Acad Sci
- Study coordinator: Barbara Ukropcová, Prof., MD, PhD
- Email: barbara.ukropcova@savba.sk
- Phone: 00421911643630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.