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

Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks and Enhancing Health systeM Resilience in Pregnant Women

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.

Inclusion Criteria:

• Pregnant Women (PW) aged 20 to 35 years
• being in the 2nd trimester of a singleton pregnancy (15th-27th week of gestation)
• Living in Catania (Italy) or Limassol (Cyprus) districts
• Clinically healthy
• No Gestational diabetes
• No pre-eclampsia
• No severe pregnancy complications

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