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

3 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

102

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cipro
      • Limassol, Cipro
        • Reclutamento
        • Medical School, University of Cyprus
        • Contatto:
  • Italia
      • Catania, Italia
        • Reclutamento
        • Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Altri nomi:
  • Behavioral intervention to reduce exposure to heat and air-pollution
Nessun intervento: Control group
Subjects in this arm will receive no alerts forhigh temperatures nor recommendations formitigation of heat-related health effects.
Sperimentale: 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.
Altro: 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
Altri nomi:
  • Behavioral intervention to reduce exposure to heat

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pittsburgh Sleep Quality Index (PSQI)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sleep-wake pattern
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Cyprus

Collaboratori

University of Catania
Azienda ospedaliera Garibaldi Catania

Investigatori

  • Investigatore principale: Panayiotis Yiallouros, Professor, University of Cyprus

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2026

Completamento primario (Stimato)

31 luglio 2027

Completamento dello studio (Stimato)

31 luglio 2027

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

27 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 101156653.LL2.PW
  • 101156653 (Altro numero di sovvenzione/finanziamento: European Commission)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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