CClinicalTrials.gg
RecruitingNCT06192069Updated Apr 23, 2024

Heat Strain Prevention in Elderly Agricultural Workers

An interventional study of Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW) in Heat Stress Disorders, Heat Stroke and Heat Exhaustion, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Heat Stress Disorders
  • Heat Stroke
  • Heat Exhaustion
  • Heat Cramps
03

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Sustainable Prevention Program

    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

    Other: Sustainable Heat Strain Prevention Program for Agricultural Elderly Workers (SHiP-AEW)

  • No intervention
    Control

    Participants will receive no intervention and follow their usual workplace heat strain prevention measures such as basic hydration and voluntary rest breaks

Interventions

  • OtherSustainable 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:

05

What researchers measure

Primary outcomes

  1. 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).

    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

06

Study locations

1 of 1 sites recruiting
07

References and documents

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. Erratum In: Occup Environ Med. 2018 Feb;75(2):162. doi: 10.1136/oemed-2016-103848corr1. PubMed 28093502 ↗
  • 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. PubMed 33367558 ↗
  • 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. PubMed 20665306 ↗
  • 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. PubMed 32235716 ↗
  • 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. PubMed 36104813 ↗
  • 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. PubMed 35114899 ↗
  • 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. doi: 10.1016/S2542-5196(23)00167-5. PubMed 36495891 ↗
  • 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. PubMed 35211437 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06192069
Lead sponsor
Cairo University
Responsible party
Mostafa Shaban (Lecturer, Cairo University) — Principal investigator
First posted
Jan 5, 2024
Start date
Jan 10, 2024
Primary completion
Apr 18, 2024
Completion
May 20, 2024 (estimated)
Last update
Apr 23, 2024

Study contacts

Mostafa shaban
Contact
MOSTAFA.SHABAN2020@CU.EDU.EG
0565644617

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion