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Recruiting NCT07634952

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

No phase Interventional Heat Strain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Heat intervention, Heat and air pollution mitigation intervention.
Who it may be relevant to
Registry conditions: Heat Strain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other 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
  • Other 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.

Primary outcome measures

  • Heat Strain Score Index [Time frame: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
Secondary outcome measures (12)
  • Daily heart rate [Time frame: Daily measurements - for the whole duration of follow-up (2 months) .]
  • Sleep-wake time [Time frame: Daily measurements - for the whole duration of follow-up (2 months)]
  • Sleep-Wake Time self-reported evaluation [Time frame: 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) [Time frame: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
  • Hamilton Anxiety Rating Scale [Time frame: 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 [Time frame: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
  • Heart Rate [Time frame: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
  • Heart Rate Variability [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Greece · 1 center
  • University of Thessaly — Trikala
Spain · 1 center
  • University of Léon — León

Identifiers

NCT: NCT07634952 · 101156653.LL1.OW · 101156653

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗