NCT07634952

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started May 2026

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
May 2026Jul 2027

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Heat Strain

Keywords

outdoor workersheat straininterventionpersonal ambient temperature exposure

Outcome Measures

Primary Outcomes (1)

  • Heat Strain Score Index

    The Heat Strain Score Index (HSSI) is a questionnaire-based assessment tool used to assess the risk of heat strain on individuals exposed to hot environments, using a questionnaire. It integrates multiple factors, such as environmental conditions, work intensity, clothing, and physiological responses, to estimate the likelihood of heat stress affecting a person.

    The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

Secondary Outcomes (26)

  • Daily heart rate

    Daily measurements - for the whole duration of follow-up (2 months) .

  • Sleep-wake pattern

    Daily measurements - for the whole duration of follow-up (2 months)

  • Sleep-Wake 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).

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  • Hamilton Anxiety Rating Scale

    The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  • +21 more secondary outcomes

Study Arms (3)

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.

Other: Heat intervention

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.

Other: Heat and air pollution mitigation intervention

Interventions

Heat interventionOTHER

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 to be developed by the project research team

Also known as: Behavioral intervention to reduce exposure to heat
Heat intervention - Personal Alerts and Specific Recommendations
Heat and air pollution mitigation interventionOTHER

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.

Also known as: Behavioral intervention to reduce exposure to heat and air-pollution
Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Thessaly

Trikala, Greece

RECRUITING

University of Léon

León, Spain

RECRUITING

MeSH Terms

Interventions

Hot TemperatureAir Pollution

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthEnvironmental PollutionPublic Health

Study Officials

  • Panayiotis Yiallouros, Professor

    University of Cyprus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayiotis Yiallouros, Professor

CONTACT

+35722895212yiallouros.panayiotis@ucy.ac.cy

Panayiotis Kouis, PhD

CONTACT

+35722895243kouis.panayiotis@ucy.ac.cy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized into three parallel study groups to a) receive no alerts for high temperatures nor recommendations for mitigation of health effects (business as usual scenario, control group), b) 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 A/C devices, as well as recommendations for mitigation of health effects (hydration, body cooling) in written and animated format, through mobile phone and web application tools (heat mitigation intervention), and c) receive alerts and recommendations as in group (b) and in addition continuously use air cleaners with HEPA filter for removing PM from indoor air in their residences (heat and air pollution mitigation intervention)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)GR(1)