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| ID | Type | Description | Link |
|---|---|---|---|
| 101156653 | Other Identifier | European Commission |
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| Name | Class |
|---|---|
| Azienda ospedaliera Garibaldi Catania | UNKNOWN |
| University of Catania | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-wake pattern | 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) |
| Sleep-Wake self-reported evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panayiotis Yiallouros, Professor | Contact | +35722895212 | yiallouros.panayiotis@ucy.ac.cy | |
| Panayiotis Kouis, PhD | Contact | +35722895243 | kouis.panayiotis@ucy.ac.cy |
| Name | Affiliation | Role |
|---|---|---|
| Panayiotis Yiallouros, Professor | University of Cyprus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical School, University of Cyprus | Recruiting | Limassol | Cyprus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13638508 | Background | 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. | |
| 2748771 | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006358 | Hot Temperature |
| D000397 | Air Pollution |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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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)
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| 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. |
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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 | 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 | 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 | 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 | 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). |
| Heart Rate Variability | 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 | 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 Urea Levels | 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 | 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 | 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 Potassium Levels | 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). |
| Serum Osmolality | 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 | 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 | 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 | 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 | 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). |
| The personal ambient temperature profile of all participants | 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) |
| Wet-bulb globe temperature (WGBT) | Wet-bulb globe temperature, will be assessed as a thermal stress indicator. | Daily measurements - for the whole duration of follow-up (2 months). |
| Humidity | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania | Recruiting | Catania | Italy |
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| Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania | Recruiting | Catania | Italy |
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| D001523 |
| Mental Disorders |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D004787 | Environmental Pollution |
| D011634 | Public Health |