Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
METSGREEN
Noise and/or Ultrafine Particulate Matter Induced Cerebral and Cardiovascular Damage: Experimental and Epidemiological Studies (MARKOPOLO) and Lifestyle Intervention to Attenuate Cardiovascular Health Risk (METSGREEN)
2 other identifiers
interventional
180
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
November 28, 2025
November 1, 2025
8 months
July 24, 2025
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Prevalence of cardiovascular diseases (CVD)
Assessed using standardized questionnaire; Unit: % of participants with diagnosed CVD.
Baseline and 12 months.
Blood pressure levels
measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).
Baseline and 12 months.
Waist circumference
measured with standard measuring tape. Unit: cm.
Baseline and 12 months.
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
Baseline and 12 months.
Secondary Outcomes (6)
Waist circumference
Baseline and after 7-day lifestyle intervention.
Blood pressure levels
Baseline and after 7-day lifestyle intervention
High-density lipoprotein (HDL)
Baseline and after 7-day lifestyle intervention.
Triglycerides
Baseline and after 7-day lifestyle intervention.
Plasma glucose
Baseline and after 7-day lifestyle intervention.
- +1 more secondary outcomes
Study Arms (3)
Control group (usual routine)
NO INTERVENTIONParticipants in this group will continue their regular daily activities without any changes imposed. They will not receive specific instructions on physical activity or diet but will undergo the same measurements and monitoring as other groups for comparison purposes.
Green Space Activity Group - Daily Physical Activity
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participants 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.
Participants 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.
Eligibility Criteria
You may qualify if:
- 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
- Agreement to wear a wristband sensor continuously for 7 days
You may not qualify if:
- Unstable angina or cardiomyopathy
- Blood pressure \>160/110 mmHg
- Neurological diseases or limited mobility
- Presence of a cardiac pacemaker
- Pregnancy
- Alcohol dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regina Grazulevicienelead
- Lithuanian University of Health Sciencescollaborator
Study Sites (2)
Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences
Kaunas, Kaunas County, 53361, Lithuania
Department of Family Medicine, Lithuanian University of Health Sciences
Kaunas, 44248, Lithuania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regina Grazuleviciene, prof.
Vytautas Magnus University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 24, 2025
First Posted
August 8, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Data will become available for this study and stored for 10 years after study completion at the study center. This retention period complies with international agreements to support long-term EU environmental and health programs.