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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Green Space Activity Group - Daily Physical Activity
BehavioralParticipants in this group will be instructed to take a brisk 30-minute walk each day in designated urban green spaces (e.g., parks, forested areas). Physical activity will be monitored using Fitbit Alta wristband sensors to track duration, intensity, and steps.
Mediterranean Diet Group - Dietary Intervention
BehavioralParticipants in this group will follow the principles of the Mediterranean diet, including increased consumption of fruits, vegetables, whole grains, legumes, nuts, and olive oil, and reduced intake of red meat and processed foods. They will receive dietary guidance and support for meal planning throughout the 7-day intervention.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of cardiovascular diseases (CVD)
Assessed using standardized questionnaire; Unit: % of participants with diagnosed CVD.
Blood pressure levels
measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).
Waist circumference
measured with standard measuring tape. Unit: cm.
Anthropometric measurements (BMI)
Body Mass Index (BMI) calculated by dividing weight in kilograms by the square of height in meters (kg/m²) Measured using a calibrated scale and stadiometer; Unit: kg/m²
Secondary outcomes
Waist circumference
Measured with standard measuring tape; Unit: cm
Blood pressure levels
Measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).
High-density lipoprotein (HDL)
measured from fasting blood samples using standard biochemical assay; Unit: mmol/L
Triglycerides
measured from fasting blood samples using standard biochemical assay; Unit: mmol/L.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Regina Grazuleviciene
Lead sponsor
Vytautas Magnus University
Sponsor institution
Lithuanian University of Health Sciences
Collaborator