Ambient air and noise pollution effect on cardiovascular health risk and lifestyle intervention to attenuate it: study protocol for a randomized clinical trial.
A few recent studies have associated ultrafine particulate matter (UFP) with metabolic disorders, contributing to cardiovascular disease, however, evidence is inconsistent. This study aims to investigate the causal relationship between long-term ultrafine particles (UFP) and noise exposures on cardiovascular disease and whether short-term healthy lifestyle interventions can reduce the risks of metabolic disorders.
The research starts from an observational cross-sectional study which involves 1,000 randomly selected 45-64-year-old Kaunas city (Lithuania) men and women. Then a three-arm randomized healthy lifestyle trial of 180 participants is conducted to study the effects of short-term lifestyle interventions, such as promoting physical activity in green spaces and Mediterranean diet. The pollution exposure patterns and the resulting health impacts are estimated on the spatial distribution and participants home addresses. The randomized trial health endpoints will be physicians assessed before intervention on Day 1 and on Day 8 (after intervention) using 7-days monitoring sensors data, clinical survey data, clinical biomarkers of metabolic disorders, and novel cardiometabolic biomarkers. Mathematical models and advanced analytical chemistry techniques will be used to estimate the associations and the effects of the interventions.
This clinical trial with an interdisciplinary approach can provide new insights by evaluating the combined impact of UFP and noise on the indicators of metabolic syndrome and the effects of short-term lifestyle interventions, such as promoting physical activity in green spaces and healthy diets. It can strengthen the evidence base for pollution-disease associations and provide practical recommendations for reducing the burden of metabolic disorders and cardiovascular diseases.
https://www.clinicaltrials.gov/study/NCT07111208, NCT07111208.
The research starts from an observational cross-sectional study which involves 1,000 randomly selected 45-64-year-old Kaunas city (Lithuania) men and women. Then a three-arm randomized healthy lifestyle trial of 180 participants is conducted to study the effects of short-term lifestyle interventions, such as promoting physical activity in green spaces and Mediterranean diet. The pollution exposure patterns and the resulting health impacts are estimated on the spatial distribution and participants home addresses. The randomized trial health endpoints will be physicians assessed before intervention on Day 1 and on Day 8 (after intervention) using 7-days monitoring sensors data, clinical survey data, clinical biomarkers of metabolic disorders, and novel cardiometabolic biomarkers. Mathematical models and advanced analytical chemistry techniques will be used to estimate the associations and the effects of the interventions.
This clinical trial with an interdisciplinary approach can provide new insights by evaluating the combined impact of UFP and noise on the indicators of metabolic syndrome and the effects of short-term lifestyle interventions, such as promoting physical activity in green spaces and healthy diets. It can strengthen the evidence base for pollution-disease associations and provide practical recommendations for reducing the burden of metabolic disorders and cardiovascular diseases.
https://www.clinicaltrials.gov/study/NCT07111208, NCT07111208.
Authors
Grazuleviciene Grazuleviciene, Andrusaityte Andrusaityte, Dedele Dedele, Kapustinskaite Kapustinskaite
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