Heat Stress DisordersNCT06192069
Heat Strain Prevention in Elderly Agricultural Workers
A study testing Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW) in people with Heat Stress Disorders and Heat Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
The study explores a multi-component heat strain prevention program for older agricultural workers in response to climate change. It assesses hydration, rest breaks, reflective clothing, and shade provision. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress Disorders, Heat Stroke, Heat Exhaustion
- What is being tested?
- Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Actively working in agricultural occupations (farming, field labor, etc.)
- Available to participate during the 4-week intervention timeline
- Fluent in spoken and written Arabic
- Agree to wear physiological monitoring devices during work
Who cannot join
- Unable to provide informed consent
- Cognitive impairments affecting ability to understand and implement program guidelines
- Dependence on supportive equipment like canes or wheelchairs
- Chronic medical conditions expected to worsen with heat exposure (e.g. uncontrolled cardiovascular disease, kidney failure)
- Required regular medications that impair thermoregulation
- Allergies or sensitivities to monitoring devices and their attachments that cannot be mitigated
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Giza
Mohamed Ezzelregal Abdelgawad, mohamed.ezz@alexu.edu.eg
About this study
Official title: The Impact of a Sustainable Prevention Program on Heat Strain Among Agricultural Elderly Workers in the Context of Climate Change
The study explores a multi-component heat strain prevention program for older agricultural workers in response to climate change. It assesses hydration, rest breaks, reflective clothing, and shade provision. Utilizing a quasi-experimental design, it targets 120 elderly workers, evaluating core temperature, heart rate, and heat strain symptoms. The goal is to establish the program's effectiveness in safeguarding worker health and safety amidst increasing temperatures, offering evidence-based recommendations for this vulnerable group and potentially other occupations affected by climate change.
Read the detailed description
This intervention study is designed to assess the efficacy of a sustainable heat strain prevention program tailored for elderly agricultural workers. It targets a specific population of 120 workers aged 60 years and above from Manial Shiha village. The study utilizes a quasi-experimental pretest-posttest design, dividing participants into intervention and control groups.
The core of the study involves a 4-week Sustainable Prevention Program, emphasizing practical and adoptable strategies like adequate hydration, regular rest breaks, the use of lightweight reflective clothing, and the provision of portable shade covers. This program is delivered through interactive methods including lectures, demonstrations, and group discussions, supplemented with educational materials.
Physiological responses to the program will be rigorously measured, employing core temperature sensors and heart rate monitors to provide objective data on the physical impact of the interventions. These measures, along with self-reported symptoms and heat strain levels collected through structured questionnaires, form the basis for a comprehensive evaluation of the program's effectiveness.
The study aims to provide a quantifiable reduction in heat strain indicators, offering insights into the program's potential for broader application in similar vulnerable populations
- Conditions
- Heat Stress Disorders, Heat Stroke, Heat Exhaustion, Heat Cramps
- Being tested
- Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)
- Medical subject headings
- Heat Stress Disorders, Heat Stroke, Heat Exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)Other
The SHiP-AEW is a 4-week multifaceted intervention program focused on evidence-based heat strain prevention strategies for agricultural workers over 60 years old. Delivered through weekly 1-hour sessions, the program incorporates the following primary components:
| Study group | Role | What they receive |
|---|---|---|
| Sustainable Prevention Program | Experimental | Participants will receive the 4-week Sustainable Prevention Program consisting of lectures, demonstrations, group discussions, and educational materials focused on:
Hydration strategies (proper amounts and types of fluids, reminders for intake) Rest breaks (frequency, duration, scheduling) Lightweight reflective clothing
Device: Core Temperature Sensor
Participants might be equipped with a core temperature sensor to monitor their internal body temperatures. This device will provide continuous, real-time data crucial for understanding the physiological impacts of the prevention strategies and ensuring participant safety.
Device: Heart Rate Monitor
A heart rate monitor will be used to track the cardiovascular responses of the participants to heat and physical activity. This data is essential to assess the strain on participants' bodies and the effectiveness of the prevention strategies in mitigating stress.
Portable shade covers Receives: Other: Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW) |
| Control | No intervention | Participants will receive no intervention and follow their usual workplace heat strain prevention measures such as basic hydration and voluntary rest breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heat strain score from baseline to post-intervention
The heat strain score is calculated from participant questionnaires assessing environmental conditions, workload, access to shade, and individual heat tolerance symptoms. Scores range from 0-30, with higher scores indicating greater levels of heat strain. Heat strain levels are categorized as low/no strain (score <13.5), potential risk (13.6-18), or high risk (>18).
The primary outcome measure will evaluate the change in heat strain score from baseline (before starting the Sustainable Prevention Program) to post-intervention (after completing the 4-week program).
Measured: Baseline heat strain scores will be calculated from questionnaires completed 1 week prior to launching the program Post-intervention heat strain scores will be calculated from questionnaires completed within 1 week after finishing the 4-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Jan 2024
- Primary completion18 Apr 2024
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heat Stress DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192069
- Sponsor's protocol ID
- sustenableheat
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moyce S, Mitchell D, Armitage T, Tancredi D, Joseph J, Schenker M. Heat strain, volume depletion and kidney function in California agricultural workers. Occup Environ Med. 2017 Jun;74(6):402-409. doi: 10.1136/oemed-2016-103848. Epub 2017 Jan 16.
PubMed 28093502Grimbuhler S, Viel JF. Heat Stress and Cardiac Strain in French Vineyard Workers. Ann Work Expo Health. 2021 May 3;65(4):390-396. doi: 10.1093/annweh/wxaa115.
PubMed 33367558Jackson LL, Rosenberg HR. Preventing heat-related illness among agricultural workers. J Agromedicine. 2010 Jul;15(3):200-15. doi: 10.1080/1059924X.2010.487021.
PubMed 20665306Wagoner RS, Lopez-Galvez NI, de Zapien JG, Griffin SC, Canales RA, Beamer PI. An Occupational Heat Stress and Hydration Assessment of Agricultural Workers in North Mexico. Int J Environ Res Public Health. 2020 Mar 22;17(6):2102. doi: 10.3390/ijerph17062102.
PubMed 32235716Chavez Santos E, Spector JT, Egbert J, Krenz J, Sampson PD, Palmandez P, Torres E, Blancas M, Carmona J, Jung J, Flunker JC. The effect of the participatory heat education and awareness tools (HEAT) intervention on agricultural worker physiological heat strain: results from a parallel, comparison, group randomized study. BMC Public Health. 2022 Sep 15;22(1):1746. doi: 10.1186/s12889-022-14144-2.
PubMed 36104813Egbert J, Krenz J, Sampson PD, Jung J, Calkins M, Zhang K, Palmandez P, Faestel P, Spector JT. Accuracy of an estimated core temperature algorithm for agricultural workers. Arch Environ Occup Health. 2022;77(10):809-818. doi: 10.1080/19338244.2022.2033672. Epub 2022 Feb 3.
PubMed 35114899Bonell A, Sonko B, Badjie J, Samateh T, Saidy T, Sosseh F, Sallah Y, Bajo K, Murray KA, Hirst J, Vicedo-Cabrera A, Prentice AM, Maxwell NS, Haines A. Environmental heat stress on maternal physiology and fetal blood flow in pregnant subsistence farmers in The Gambia, west Africa: an observational cohort study. Lancet Planet Health. 2022 Dec;6(12):e968-e976. doi: 10.1016/S2542-5196(22)00242-X.
PubMed 36495891El Khayat M, Halwani DA, Hneiny L, Alameddine I, Haidar MA, Habib RR. Impacts of Climate Change and Heat Stress on Farmworkers' Health: A Scoping Review. Front Public Health. 2022 Feb 8;10:782811. doi: 10.3389/fpubh.2022.782811. eCollection 2022.
PubMed 35211437Shaban M, Amer FGM, Shaban MM. The impact of nursing sustainable prevention program on heat strain among agricultural elderly workers in the context of climate change. Geriatr Nurs. 2024 Jul-Aug;58:215-224. doi: 10.1016/j.gerinurse.2024.05.021. Epub 2024 Jun 4.
PubMed 38838403
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Sustainable Prevention Program on Heat Strain Among Agricultural Elderly Workers in the Context of Climate Change
- ClinicalTrials.gov ID
- NCT06192069
- Acronym / sponsor ID
- sustenableheat
- Conditions
- Heat Stress Disorders, Heat Stroke, Heat Exhaustion, Heat Cramps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study explores a multi-component heat strain prevention program for older agricultural workers in response to climate change. It assesses hydration, rest breaks, reflective clothing, and shade provision. Utilizing a quasi-experimental design, it targets 120 elderly workers, evaluating core temperature, heart rate, and heat strain symptoms. The goal is to establish the program's effectiveness in safeguarding worker health and safety amidst increasing temperatures, offering evidence-based recommendations for this vulnerable group and potentially other occupations affected by climate change.
Detailed description
This intervention study is designed to assess the efficacy of a sustainable heat strain prevention program tailored for elderly agricultural workers. It targets a specific population of 120 workers aged 60 years and above from Manial Shiha village. The study utilizes a quasi-experimental pretest-posttest design, dividing participants into intervention and control groups.
The core of the study involves a 4-week Sustainable Prevention Program, emphasizing practical and adoptable strategies like adequate hydration, regular rest breaks, the use of lightweight reflective clothing, and the provision of portable shade covers. This program is delivered through interactive methods including lectures, demonstrations, and group discussions, supplemented with educational materials.
Physiological responses to the program will be rigorously measured, employing core temperature sensors and heart rate monitors to provide objective data on the physical impact of the interventions. These measures, along with self-reported symptoms and heat strain levels collected through structured questionnaires, form the basis for a comprehensive evaluation of the program's effectiveness.
The study aims to provide a quantifiable reduction in heat strain indicators, offering insights into the program's potential for broader application in similar vulnerable populations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustainable Prevention Program | Experimental | Other: Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)Participants will receive the 4-week Sustainable Prevention Program consisting of lectures, demonstrations, group discussions, and educational materials focused on: Hydration strategies (proper amounts and types of fluids, reminders for intake) Rest breaks (frequency, duration, scheduling) Lightweight reflective clothing Device: Core Temperature Sensor Participants might be equipped with a core temperature sensor to monitor their internal body temperatures. This device will provide continuous, real-time data crucial for understanding the physiological impacts of the prevention strategies and ensuring participant safety. Device: Heart Rate Monitor A heart rate monitor will be used to track the cardiovascular responses of the participants to heat and physical activity. This data is essential to assess the strain on participants' bodies and the effectiveness of the prevention strategies in mitigating stress. Portable shade covers |
| Control | No intervention | –Participants will receive no intervention and follow their usual workplace heat strain prevention measures such as basic hydration and voluntary rest breaks |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years or older
- Actively working in agricultural occupations (farming, field labor, etc.)
- Available to participate during the 4-week intervention timeline
- Fluent in spoken and written Arabic
- Agree to wear physiological monitoring devices during work
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Cognitive impairments affecting ability to understand and implement program guidelines
- Dependence on supportive equipment like canes or wheelchairs
- Chronic medical conditions expected to worsen with heat exposure (e.g. uncontrolled cardiovascular disease, kidney failure)
- Required regular medications that impair thermoregulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)The SHiP-AEW is a 4-week multifaceted intervention program focused on evidence-based heat strain prevention strategies for agricultural workers over 60 years old. Delivered through weekly 1-hour sessions, the program incorporates the following primary components: | Other | Sustainable Prevention Program |
Primary outcome
Change in heat strain score from baseline to post-intervention
Time frame: Baseline heat strain scores will be calculated from questionnaires completed 1 week prior to launching the program Post-intervention heat strain scores will be calculated from questionnaires completed within 1 week after finishing the 4-week program
The heat strain score is calculated from participant questionnaires assessing environmental conditions, workload, access to shade, and individual heat tolerance symptoms. Scores range from 0-30, with higher scores indicating greater levels of heat strain. Heat strain levels are categorized as low/no strain (score <13.5), potential risk (13.6-18), or high risk (>18). The primary outcome measure will evaluate the change in heat strain score from baseline (before starting the Sustainable Prevention Program) to post-intervention (after completing the 4-week program).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 28093502Moyce S, Mitchell D, Armitage T, Tancredi D, Joseph J, Schenker M. Heat strain, volume depletion and kidney function in California agricultural workers. Occup Environ Med. 2017 Jun;74(6):402-409. doi: 10.1136/oemed-2016-103848. Epub 2017 Jan 16.
- Background: PubMed 33367558Grimbuhler S, Viel JF. Heat Stress and Cardiac Strain in French Vineyard Workers. Ann Work Expo Health. 2021 May 3;65(4):390-396. doi: 10.1093/annweh/wxaa115.
- Background: PubMed 20665306Jackson LL, Rosenberg HR. Preventing heat-related illness among agricultural workers. J Agromedicine. 2010 Jul;15(3):200-15. doi: 10.1080/1059924X.2010.487021.
- Background: PubMed 32235716Wagoner RS, Lopez-Galvez NI, de Zapien JG, Griffin SC, Canales RA, Beamer PI. An Occupational Heat Stress and Hydration Assessment of Agricultural Workers in North Mexico. Int J Environ Res Public Health. 2020 Mar 22;17(6):2102. doi: 10.3390/ijerph17062102.
- Background: PubMed 36104813Chavez Santos E, Spector JT, Egbert J, Krenz J, Sampson PD, Palmandez P, Torres E, Blancas M, Carmona J, Jung J, Flunker JC. The effect of the participatory heat education and awareness tools (HEAT) intervention on agricultural worker physiological heat strain: results from a parallel, comparison, group randomized study. BMC Public Health. 2022 Sep 15;22(1):1746. doi: 10.1186/s12889-022-14144-2.
- Background: PubMed 35114899Egbert J, Krenz J, Sampson PD, Jung J, Calkins M, Zhang K, Palmandez P, Faestel P, Spector JT. Accuracy of an estimated core temperature algorithm for agricultural workers. Arch Environ Occup Health. 2022;77(10):809-818. doi: 10.1080/19338244.2022.2033672. Epub 2022 Feb 3.
- Background: PubMed 36495891Bonell A, Sonko B, Badjie J, Samateh T, Saidy T, Sosseh F, Sallah Y, Bajo K, Murray KA, Hirst J, Vicedo-Cabrera A, Prentice AM, Maxwell NS, Haines A. Environmental heat stress on maternal physiology and fetal blood flow in pregnant subsistence farmers in The Gambia, west Africa: an observational cohort study. Lancet Planet Health. 2022 Dec;6(12):e968-e976. doi: 10.1016/S2542-5196(22)00242-X.
- Background: PubMed 35211437El Khayat M, Halwani DA, Hneiny L, Alameddine I, Haidar MA, Habib RR. Impacts of Climate Change and Heat Stress on Farmworkers' Health: A Scoping Review. Front Public Health. 2022 Feb 8;10:782811. doi: 10.3389/fpubh.2022.782811. eCollection 2022.
- Derived from this study: PubMed 38838403Shaban M, Amer FGM, Shaban MM. The impact of nursing sustainable prevention program on heat strain among agricultural elderly workers in the context of climate change. Geriatr Nurs. 2024 Jul-Aug;58:215-224. doi: 10.1016/j.gerinurse.2024.05.021. Epub 2024 Jun 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW) in people with Heat Stress Disorders and Heat Stroke, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa shaban (0565644617, MOSTAFA.SHABAN2020@CU.EDU.EG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heat strain score from baseline to post-intervention (time frame: Baseline heat strain scores will be calculated from questionnaires completed 1 week prior to launching the program Post-intervention heat strain scores will be calculated from questionnaires completed within 1 week after finishing the 4-week program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192069, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.