About this trial
This study, combining both an observational study and an interventional clinical trial, aims to assess how exposure to ultrafine particulate matter (PM0.1) and noise pollution affects the risk of cardiovascular diseases and metabolic disorders in 45-64-year-old residents of Kaunas City, and whether lifestyle interventions-specifically physical activity in green spaces and the Mediterranean diet-can help reduce these risks.
In the observational part, approximately 1,000 randomly selected 45-64 years men and women living in private households will complete an anonymous online health and lifestyle questionnaire. The clinical interventional trial will include 180 participants, who agreed to participate in the clinical study and, who meet specific health criteria. The main questions the study seeks to answer are: whether increased exposure to PM0.1 and noise is linked to higher cardiovascular and metabolic risk; and whether short-term healthy lifestyle changes can improve biological markers associated with these conditions.
Participants in the clinical trial will be randomly assigned to one of three groups: (1) control group continuing usual habits, (2) physical activity group at least 30-minute daily walks in green spaces, or (3) group adherence to a Mediterranean diet. They will have two visits to the clinic for health surveys:
* Wear a wristband sensor for 7 days to monitor physical activity, heart rate, and sleep quality * Visit a clinic on Day 1 and Day 8 for measurements (blood pressure, waist circumference, body composition) and give blood samples for biomarker analysis.
This research will provide new evidence on environmental health risks and practical recommendations for reducing the burden of metabolic and cardiovascular diseases.
Eligibility criteria
Qualifiers
Age 45-64 years
Residence in Kaunas City
Presence of metabolic disorder indicators (e.g., increased waist circumference and/or elevated blood pressure)
Willingness to participate and provide written informed consent
Disqualifiers
Unstable angina or cardiomyopathy
Blood pressure >160/110 mmHg
Neurological diseases or limited mobility
Presence of a cardiac pacemaker
Trial design
Treatments tested in this trial
- Green Space Activity Group - Daily Physical Activity
- Mediterranean Diet Group - Dietary Intervention
Treatment groups
Sponsors and collaborators
Regina Grazuleviciene
Lead sponsor
Vytautas Magnus University
Sponsor institution
Lithuanian University of Health Sciences
Collaborator