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A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers

Primary Purpose

Heat Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heat Education and Awareness Tools
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Stress Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • Farms (confidential)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

HEAT intervention group

Comparison group

Arm Description

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.

The comparison group will not be offered HEAT trainings or the HEAT awareness application. They will be offered an alternative training on another topic.

Outcomes

Primary Outcome Measures

Heat-related Illness Symptoms
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.
Heat Strain
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.

Secondary Outcome Measures

Pre/post Knowledge Assessment
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.
Pre/post Supervisor Survey
Short set of interview questions to learn about heat safety practices and utilization of the HEAT awareness application for intervention group

Full Information

First Posted
January 14, 2020
Last Updated
May 16, 2022
Sponsor
University of Washington
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
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1. Study Identification

Unique Protocol Identification Number
NCT04234802
Brief Title
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
Official Title
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a parallel, comparison, group intervention study to evaluate the effectiveness of a multi-level Heat Education and Awareness Tools (HEAT) intervention, consisting of worker training and a supervisor heat awareness application, on reducing adverse heat health effects in agricultural workers across a growing season.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEAT intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Comparison group
Arm Type
No Intervention
Arm Description
The comparison group will not be offered HEAT trainings or the HEAT awareness application. They will be offered an alternative training on another topic.
Intervention Type
Other
Intervention Name(s)
Heat Education and Awareness Tools
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heat-related Illness Symptoms
Description
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.
Time Frame
Approximately three months
Title
Heat Strain
Description
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.
Time Frame
Approximately three months
Secondary Outcome Measure Information:
Title
Pre/post Knowledge Assessment
Description
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.
Time Frame
Approximately three months
Title
Pre/post Supervisor Survey
Description
Short set of interview questions to learn about heat safety practices and utilization of the HEAT awareness application for intervention group
Time Frame
Approximately three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June T Spector, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farms (confidential)
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
36104813
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.
Results Reference
derived
PubMed Identifier
35345983
Citation
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. 2023 Apr;28(2):187-198. doi: 10.1080/1059924X.2022.2058667. Epub 2022 Apr 17.
Results Reference
derived
PubMed Identifier
34169175
Citation
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.
Results Reference
derived

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A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers

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