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临床试验/NCT07634952
NCT07634952招募中不适用

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

University of Cyprus2 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2026年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
2

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control group

No Intervention

Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects.

Heat intervention - Personal Alerts and Specific Recommendations

Experimental

Subjects in this group will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat and mitigation of heat-related health effects in written and animated format through mobile phones, mobile applications and online tools.

干预措施: Heat intervention (Other)

Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners

Experimental

Subjects in this group will receive alerts and recommendations as in group "Heat intervention" and in addition, continuously use of air cleaners with HEPA filter for removing PM from indoor air in their residences and workplaces to provide evidence for health benefits.

干预措施: Heat and air pollution mitigation intervention (Other)

结局指标

主要结局

未指定

次要结局

  • Sleep-wake time(Daily measurements - for the whole duration of follow-up (2 months))
  • Sleep-Wake Time self-reported evaluation(The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panayiotis Yiallouros

Professor

University of Cyprus

研究点 (2)

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