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

NCT07609433 | Recruiting DMC

• 2 other identifiers: 101156653.LL2.PW101156653
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 3

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 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

Keywords

Pregnancy; intervention; Sleep quality; personal ambient temperature exposure

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

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

Secondary Outcomes (27)

• 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).

• 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).

• Daily heart rate

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

• Systolic/Diastolic Blood Pressure

  Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

Study Arms (3)

Control group

NO INTERVENTION

Subjects in this arm will receive no alerts forhigh temperatures nor recommendations formitigation of heat-related health effects.

Heat intervention - Personal Alerts and Specific Recommendations

EXPERIMENTAL

Subjects in this group will receive timelypersonal 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 intervention OTHER

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 intervention OTHER

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

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• University of Cyprus: lead
• Azienda ospedaliera Garibaldi Catania: collaborator
• University of Catania: collaborator

Study Sites (3)

Medical School, University of Cyprus

Limassol, Cyprus

RECRUITING

Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania

Catania, Italy

RECRUITING

Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania

Catania, Italy

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Hot Temperature; Air Pollution

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Panayiotis Yiallouros, Professor

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayiotis Yiallouros, Professor

CONTACT

+35722895212; yiallouros.panayiotis@ucy.ac.cy

Panayiotis Kouis, PhD

CONTACT

+35722895243; kouis.panayiotis@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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)

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); CY (1)