- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538778
Assessment of Climate Change Related Heat Stress Among Workers in Upper Egypt : Impact of Intervention Program on Physiological Responses
Climate change has a significant impact on human health and productivity at work. According to the Intergovernmental Panel on Climate Change (IPCC) and the United Nations, climate change is one of the most significant global challenges of the 21st century. It is defined by the United Nations Framework Convention on Climate Change (UNFCCC) as "a change in climate that is directly or indirectly attributable to human activity that alters the composition of the global atmosphere and that is in addition to the natural climate variability observed over comparable time periods".
Climate change has led to a significant increase in global average temperatures; temperatures on average have increased by about 1.1°C since pre-industrial times . In addition, the intensity, frequency, and duration of heatwaves have been rapidly increasing around the globe . Nineteen out of the 20 warmest years on record have occurred since 2000.
Occupational exposure associated with rising temperatures and climate change has become a concern to the health and safety, productivity, and social well-being of the world's diversified workforce. As a result, the 2030 Sustainable Development Goals (SDGs) are focused on ensuring healthy lifestyles, promoting wellbeing, ensuring decent employment and work capacity, and combating the effects of climate change on all sectors of development. Climate change continues to pose an immediate and long-term threat to human survival around the world; hence, the global agenda to promote humanity's well-being by combating rising temperatures and the impacts of climate change, as stated in the Sustainable Development Goals (SDG 13).
In tropical regions in low-and middle-income countries, rural populations often work in hot climates, live in dwellings that are not thermally efficient, and are unable to access fans or air conditioners. Laboring in high heat increases the risk of heat-related injuries and illnesses. Egypt is especially vulnerable to climate change due to its geographic location and reliance on climate sensitive economic sectors.
Exposure to heat can cause a range of adverse health effects including damage to major organs and even death if the core temperature of the body exceeds 42 °C .
Working people's exposure to hot environments to heat-related health effects such respiratory, heart, and renal illnesses. Even in healthy people, heat stress has the potential to produce acute kidney damage through volume depletion. Numerous heat-related symptoms, including exhaustion, headaches, muscle cramps, weakness, nausea, vomiting, tachycardia, hyperventilation, and chest pain that may be mild or severe depending on severity, ataxia, hypotension, syncope, and momentary changes in mental status, can all be signs of heat stress.
It is possible that in some cases the asymptomatic rise in serum creatinine levels represents a dehydration-related decrease in renal perfusion without structural injury or that the rise in the creatinine level does not represent a true fall in the estimated glomerular filtration rate (eGFR). However, there is concern that changes in the creatinine level during the work shift may represent injury to the kidneys, which, if repetitive, could confer a predisposition to chronic kidney disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >18 years old
- Both sex
- workers with a duration of work more than one year.
- Workers exposed to hot environmental conditions during daily work.
Exclusion Criteria:
- Workers with severe chronic medical conditions that may independently affect heat tolerance (e.g., advanced cardiac, renal, or endocrine disorders).
- Workers not regularly engaged in outdoor fieldwork (administrative or indoor workers).
- Workers who refused to participate or withdrew from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
|
worker not recives any health education
|
|
Active Comparator: Heat Stress Awareness Program
|
The HSAP consisted of training and medical monitoring of enrolled employees.
The program will be conducted before hot session and reevaluation will be conducted after end of hot session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in self-reported heat-related illness (HRI) symptoms during work
Time Frame: baseline and 3 months after intervention
|
change in self-reported heat-related illness (HRI) symptoms during work .number of workers who have heat-related illness before and after intervention program
|
baseline and 3 months after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Climate Change Heat Stress
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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