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Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution (ISMED CLIM PW)

3 июня 2026 г. обновлено: Panayiotis Yiallouros, University of Cyprus

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

102

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

  • Имя: Panayiotis Kouis, PhD
  • Номер телефона: +35722895243
  • Электронная почта: kouis.panayiotis@ucy.ac.cy

Места учебы

  • Италия
      • Catania, Италия
        • Рекрутинг
        • Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania
        • Контакт:
          • Antonella Agodi
          • Номер телефона: +390953782183
          • Электронная почта: antonella.agodi@unict.it
  • Кипр
      • Limassol, Кипр
        • Рекрутинг
        • Medical School, University of Cyprus
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Да

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners
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.
Другой: 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.
Другие имена:
  • Behavioral intervention to reduce exposure to heat and air-pollution
Без вмешательства: Control group
Subjects in this arm will receive no alerts forhigh temperatures nor recommendations formitigation of heat-related health effects.
Экспериментальный: Heat intervention - Personal Alerts and Specific Recommendations
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.
Другой: 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
Другие имена:
  • Behavioral intervention to reduce exposure to heat

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Pittsburgh Sleep Quality Index (PSQI)
Временное ограничение: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Sleep-wake pattern
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months)
Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).
Daily measurements - for the whole duration of follow-up (2 months)
Heart Rate
Временное ограничение: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart rate will be measured using ECG.
Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
The personal ambient temperature profile of all participants
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months)
Personal exposures of participants will be monitored continuously during the two observation months with wearable sensors to be always worn and assess personal exposure to ambient (indoor and outdoor) temperature (iButton).
Daily measurements - for the whole duration of follow-up (2 months)
Serum Urea Levels
Временное ограничение: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of urea (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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
Временное ограничение: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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
Временное ограничение: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Osmolality
Временное ограничение: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Creatinine Levels
Временное ограничение: Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Sodium levels
Временное ограничение: Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Potassium levels
Временное ограничение: Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Osmolality
Временное ограничение: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Sleep-Wake self-reported evaluation
Временное ограничение: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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.
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
Временное ограничение: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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).
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
Временное ограничение: Daily measu.ments - for the whole duration of follow-up (2 months) .
Heart rate measurements taken throughout the day by a wearable device (wristband).
Daily measu.ments - for the whole duration of follow-up (2 months) .
Systolic/Diastolic Blood Pressure
Временное ограничение: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measurements of Systolic/Diastolic Blood Pressure will be recorded.
Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate Variability
Временное ограничение: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart rate variability will be measured using ECG.
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
Временное ограничение: 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 levels of C-reactive protein (mg/L), as a marker of systemic inflammation, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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 Potassium Levels
Временное ограничение: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Wet-bulb globe temperature (WGBT)
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Wet-bulb globe temperature, will be assessed as a thermal stress indicator.
Daily measurements - for the whole duration of follow-up (2 months).
Humidity
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Humidity will be measured using iButton.
Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at residence
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at work
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' work place will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 10 (PM 10) at residence
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 10 (PM 10) at work
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' work place will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Daily measurements - for the whole duration of follow-up (2 months).
Number of daily steps
Временное ограничение: Daily measurements - for the whole duration of follow-up (2 months)
Number of daily steps will be measured throughout the day by a wearable device (wristband).
Daily measurements - for the whole duration of follow-up (2 months)
Hair cortisol levels
Временное ограничение: Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
Hair cortisol levels (pg/mg), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
Saliva alpha-amylase levels
Временное ограничение: Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
Saliva levels of alpha-amylase (U/mL), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Cyprus

Соавторы

University of Catania
Azienda ospedaliera Garibaldi Catania

Следователи

  • Главный следователь: Panayiotis Yiallouros, Professor, University of Cyprus

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 мая 2026 г.

Первичное завершение (Оцененный)

31 июля 2027 г.

Завершение исследования (Оцененный)

31 июля 2027 г.

Даты регистрации исследования

Первый отправленный

29 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

19 мая 2026 г.

Первый опубликованный (Действительный)

27 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 101156653.LL2.PW
  • 101156653 (Другой номер гранта/финансирования: European Commission)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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