Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-64
SponsorRegina Grazuleviciene

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 volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Green Space Activity Group - Daily Physical Activity

    Behavioral

    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.

  • Mediterranean Diet Group - Dietary Intervention

    Behavioral

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Control group (usual routine)No intervention 0 interventions
Group B: Green Space Activity Group - Daily Physical ActivityExperimental treatment 1 intervention
Group C: Mediterranean Diet Group - Dietary InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of cardiovascular diseases (CVD)

Assessed using standardized questionnaire; Unit: % of participants with diagnosed CVD.

Time frame
Baseline and 12 months.
2

Blood pressure levels

measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).

Time frame
Baseline and 12 months.
3

Waist circumference

measured with standard measuring tape. Unit: cm.

Time frame
Baseline and 12 months.
4

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

Time frame
Baseline and 12 months.

Secondary outcomes

1

Waist circumference

Measured with standard measuring tape; Unit: cm

Time frame
Baseline and after 7-day lifestyle intervention.
2

Blood pressure levels

Measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).

Time frame
Baseline and after 7-day lifestyle intervention
3

High-density lipoprotein (HDL)

measured from fasting blood samples using standard biochemical assay; Unit: mmol/L

Time frame
Baseline and after 7-day lifestyle intervention.
4

Triglycerides

measured from fasting blood samples using standard biochemical assay; Unit: mmol/L.

Time frame
Baseline and after 7-day lifestyle intervention.

Other outcomes

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