Actively Recruiting

Phase Not Applicable
Age: 45Years - 64Years
All Genders
NCT07111208

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

Led by Regina Grazuleviciene · Updated on 2025-11-28

180

Participants Needed

2

Research Sites

162 weeks

Total Duration

On this page

Sponsors

R

Regina Grazuleviciene

Lead Sponsor

L

Lithuanian University of Health Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 to 64 years
  • Residence in Kaunas City
  • Presence of metabolic disorder indicators such as 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
Not Eligible

You will not qualify if you...

  • Unstable angina or cardiomyopathy
  • Blood pressure greater than 160/110 mmHg
  • Neurological diseases or limited mobility
  • Presence of a cardiac pacemaker
  • Pregnancy
  • Alcohol dependence

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences

Kaunas, Kaunas County, Lithuania, 53361

Not Yet Recruiting

2

Department of Family Medicine, Lithuanian University of Health Sciences

Kaunas, Lithuania, 44248

Actively Recruiting

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Research Team

R

Regina Grazuleviciene, prof.

CONTACT

S

Sandra Andrusaityte, dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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