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

Sponsor
Regina Grazuleviciene
Study ID
NCT07111208
Status
Recruiting
Apply to this trial

Conditions

  • Air Pollution Exposure
  • Cardiovascular Diseases (CVD)
  • Environmental Exposure
  • Health Behavior Change
  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
45 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 8, 2025
Start date
Oct 24, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control group (usual routine)
    Participants 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.
  • Experimental: Green Space Activity Group - Daily Physical Activity
    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.
  • Experimental: Mediterranean Diet Group - Dietary Intervention
    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.

Primary Outcome Measure

Prevalence of cardiovascular diseases (CVD) [ Time Frame: Baseline and 12 months. ]

Central Contacts

Related Studies