Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution
ConditionSleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorUniversity of Cyprus
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Heat intervention
Other interventionThe 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
Heat and air pollution mitigation intervention
Other interventionThe 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.
Treatment groups
102 Participants
are divided into 3 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Heat intervention - Personal Alerts and Specific RecommendationsExperimental treatment 1 intervention
Group C: Heat and air pollution intervention - Group Alerts, Recommendations and Air CleanersExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).Secondary outcomes
1
Sleep-wake pattern
Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).
Time frame
Daily measurements - for the whole duration of follow-up (2 months)2
Sleep-Wake self-reported evaluation
The sleep-wake self-reported evaluation will be carried out using a predefined sleep diary which will be completed by the participant on the morning after he/she wakes up. Each assessment of sleep-wake self-reported evaluation will be carried out for a whole week.
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).3
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale will be carried out to assess the severity of a person's anxiety. The Hamilton Anxiety Rating Scale ranges from 0 to 56, where higher scores indicate greater anxiety severity. The scoring is divided into severity tiers: \<17 (mild), 18-24 (mild to moderate), and 25-56 (moderate to severe). The scale consists of 14 items, each rated from 0 to 4 points. It evaluates both psychic anxiety (e.g., tension, fears, mood) and somatic anxiety (physical complaints).
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).4
Daily heart rate
Heart rate measurements taken throughout the day by a wearable device (wristband).
Time frame
Daily measu.ments - for the whole duration of follow-up (2 months) .Sponsors and contacts
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University of Cyprus
Lead sponsor
Azienda ospedaliera Garibaldi Catania
Collaborator
University of Catania
Collaborator
Source ClinicalTrials.gov