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

Official title

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

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 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.

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

• 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).]

Secondary outcome measures (12)

• Sleep-wake pattern [Time frame: Daily measurements - for the whole duration of follow-up (2 months)]
• Sleep-Wake 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).]
• 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).]
• Daily heart rate [Time frame: Daily measu.ments - for the whole duration of follow-up (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).]
• Serum Potassium Levels [Time frame: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]

Eligibility criteria

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

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

Italy · 2 centers

• Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania — Catania
• Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania — Catania

Cyprus · 1 center

• Medical School, University of Cyprus — Limassol

Publications

• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available. PMID 13638508
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771

Identifiers

NCT: NCT07609433 · 101156653.LL2.PW · 101156653

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗