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Clinical Trials/NCT07634952
NCT07634952RecruitingNot Applicable

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

University of Cyprus2 sites in 2 countries102 target enrollmentStarted: May 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
102
Locations
2

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: 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.

Intervention: Heat and air pollution mitigation intervention (Other)

Outcomes

Primary Outcomes

Not specified

Secondary Outcomes

  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Panayiotis Yiallouros

Professor

University of Cyprus

Study Sites (2)

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