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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06192069
Other study ID # sustenableheat
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2024
Est. completion date May 20, 2024

Study information

Verified date April 2024
Source Cairo University
Contact Mostafa shaban
Phone 0565644617
Email MOSTAFA.SHABAN2020@CU.EDU.EG
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 20, 2024
Est. primary completion date April 18, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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:

Locations

Country Name City State
Egypt Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Bonell 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. Erratum In: Lancet Planet Health. 2023 Aug;7(8):e648. — View Citation

Chavez 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. — View Citation

Egbert 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. — View Citation

El 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. — View Citation

Grimbuhler 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. — View Citation

Jackson LL, Rosenberg HR. Preventing heat-related illness among agricultural workers. J Agromedicine. 2010 Jul;15(3):200-15. doi: 10.1080/1059924X.2010.487021. — View Citation

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. Erratum In: Occup Environ Med. 2018 Feb;75(2):162. — View Citation

Wagoner 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
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
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