Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution

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 pregnant women.

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 sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index?

Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily 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 sleep 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 Pittsburgh Sleep Quality Index questionnaire in three repeated assessments
* Provide samples of urine and blood biomarkers in three repeated assessments.

Conditions

• Sleep Quality

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 to be developed by the project research team

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.

Sponsors & Collaborators

• Azienda ospedaliera Garibaldi Catania

  collaborator UNKNOWN

• University of Catania

  collaborator OTHER

• University of Cyprus

  lead OTHER

Principal Investigators

• Panayiotis Yiallouros, Professor · University of Cyprus

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Cyprus
• Italy

Study Locations