Mitigation of Health Effects in Outdoor Workers by Reducing Exposure to Heat and Air Pollution

Официальное название

Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks in Outdoor Workers

Обзор

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in outdoor workers. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce physiological strain experienced by individuals working in hot environments, measured using the Heat Strain Score Index? Researchers will compare measurements between outdoor workers carrying out their activities in the absence of intervention (control group), those carrying out their activities with behavioural recommendations (recommendation intervention group) and those carrying out their activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and physiological strain are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Heat Strain Score Index questionnaire in three repeated assessments * Provide samples of urine, blood, saliva and hair for measurement of various biomarkers in three repeated assessments

Вмешательства

• Другое Heat intervention
  The participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools t
• Другое Heat and air pollution mitigation intervention
  The participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces.

Первичные конечные точки

• Heat Strain Score Index [Срок оценки: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]

Вторичные конечные точки (12)

• Daily heart rate [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months) .]
• Sleep-wake time [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Sleep-Wake Time self-reported evaluation [Срок оценки: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Hamilton Anxiety Rating Scale [Срок оценки: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Systolic/Diastolic Blood Pressure [Срок оценки: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Heart Rate [Срок оценки: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Heart Rate Variability [Срок оценки: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Serum C-reactive Protein Levels [Срок оценки: Serum levels of C-reactive protein will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Serum Urea Levels [Срок оценки: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Serum Creatinine Levels [Срок оценки: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Serum Sodium levels [Срок оценки: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]

Критерии участия

Критерии включения

• 18-65 years old
• Municipality outdoor workers
• Regularly working outdoors for al least 6 hours per day
• Living in León (Spain) or Trikala (Greece)
• Clinically healthy
• No history of diabetes mellitus type 2 (DM2)
• No history of arterial hypertension

Критерии исключения

• Currently smoking
• Presence of any smoking residents in the household
• Not residing at the household for at least 5 days a week
• Planning to move from the current home within the next two months
• No access to Wi-Fi or 4G/5G mobile phone
• Severe chronic conditions (congestive heart failure, ischemic heart disease, significant valvular heart disease, DM2, inflammatory diseases, renal failure, or active cancer)
• Drugs abuse
• Alcohol abuse
• Psychiatric disorders
• Severe mental disability that interferes with answering questions or following instructions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Греция · 1 центр

• University of Thessaly — Trikala

Испания · 1 центр

• University of Léon — León

Идентификаторы

NCT: NCT07634952 · 101156653.LL1.OW · 101156653

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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