- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234802
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
May 16, 2022 updated by: June Spector, University of Washington
The project's primary aim is to evaluate the effectiveness of a multi-level heat prevention approach in reducing adverse heat health effects in outdoor agricultural workers
The secondary aims are to:
- Test the effectiveness of an individual-level training component designed to reduce adverse heat health effects in outdoor agricultural workers
- Evaluate the effectiveness of a workplace supervisor-level heat awareness application intended to support supervisor decisions to reduce the risk of workers experiencing adverse heat health effects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Yakima, Washington, United States, 98902
- Farms (confidential)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: HEAT intervention group
Workers in the intervention group will receive the HEAT training, and supervisors in the intervention group will receive the HEAT awareness application and training on how to use it.
|
HEAT training will be delivered to agricultural workers by research staff in this study in the spring.
HEAT training uses interactive approaches to engage participants and posters with visuals.
Training covers types of heat-related illness and treatments, risk factors, appropriate clothing and hydration, and keeping cool in the home and community.
The HEAT awareness application was developed in collaboration with Washington State University's AgWeatherNet Program to notify supervisors signed up for the service about hot weather conditions that might increase the risk for adverse health effects for workers.
The HEAT awareness application is designed to allow subscribers to select weather stations of interest and view current heat indices as well as maximum daily heat indices forecasted over the following week.
This information is coupled with information about health effects and prevention of adverse heat health effects.
Materials are provided in English and Spanish.
|
|
NO_INTERVENTION: Comparison group
The comparison group will not be offered HEAT trainings or the HEAT awareness application.
They will be offered an alternative training on another topic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heat-related Illness Symptoms
Time Frame: Approximately three months
|
Heat symptoms will be assessed using a short survey conducted in Spanish or English that includes questions about heat-related illness symptoms experienced over the past week.
Participants will select one or more symptoms (or select 'none') from a list.
|
Approximately three months
|
|
Heat Strain
Time Frame: Approximately three months
|
The body's physiological response to heat stress.
Core body temperature (degrees C) will be estimated using personal baseline temperature and continuous heart rate during work shifts on several days.
|
Approximately three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre/post Knowledge Assessment
Time Frame: Approximately three months
|
Short set of multiple-choice questions based on key points addressed in the one-hour training on recognition, treatment, and prevention of heat-related illness.
|
Approximately three months
|
|
Pre/post Supervisor Survey
Time Frame: Approximately three months
|
Short set of interview questions to learn about heat safety practices and utilization of the HEAT awareness application for intervention group
|
Approximately three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: June T Spector, MD, MPH, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Marquez D, Krenz JE, Chavez Santos E, Torres E, Palmandez P, Sampson PD, Blancas M, Carmona J, Spector JT. The Effect of Participatory Heat Education on Agricultural Worker Knowledge. J Agromedicine. 2022 Apr 17:1-12. doi: 10.1080/1059924X.2022.2058667. Online ahead of print.
- Krenz J, Santos EC, Torres E, Palmandez P, Carmona J, Blancas M, Marquez D, Sampson P, Spector JT. The multi-level heat education and awareness tools [HEAT] intervention study for farmworkers: Rationale and methods. Contemp Clin Trials Commun. 2021 Jun 8;22:100795. doi: 10.1016/j.conctc.2021.100795. eCollection 2021 Jun.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 22, 2019
Primary Completion (ACTUAL)
August 31, 2021
Study Completion (ACTUAL)
September 30, 2021
Study Registration Dates
First Submitted
January 14, 2020
First Submitted That Met QC Criteria
January 15, 2020
First Posted (ACTUAL)
January 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000238
- 2U54OH007544-16 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified IPD will be available upon reasonable request and/or will be available in a publicly accessible data repository.
IPD will include general demographic variables and summary physiological measurements.
IPD Sharing Time Frame
Data will be available after primary analyses are completed, approximately 1-2 years after data collection is completed.
Data will be available indefinitely.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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