跳至主要内容
临床试验/NCT07609433
NCT07609433招募中不适用

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

University of Cyprus2 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
2

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panayiotis Yiallouros

Professor

University of Cyprus

研究点 (2)

Loading locations...

相似试验

Mitigation of Health Effects in Pregnant Women by... | 临床试验