NCT04234802

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

January 14, 2020

Last Update Submit

May 16, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Approximately three months

  • 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.

    Approximately three months

Secondary Outcomes (2)

  • Pre/post Knowledge Assessment

    Approximately three months

  • Pre/post Supervisor Survey

    Approximately three months

Study Arms (2)

HEAT intervention group

ACTIVE COMPARATOR

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.

Other: Heat Education and Awareness Tools

Comparison group

NO INTERVENTION

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

Interventions

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.

HEAT intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farms (confidential)

Yakima, Washington, 98902, United States

Location

Related Publications (3)

  • 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. 2023 Apr;28(2):187-198. doi: 10.1080/1059924X.2022.2058667. Epub 2022 Apr 17.

  • 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.

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • June T Spector, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Environmental and Occupational Health Sciences; Department of Medicine

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 21, 2020

Study Start

May 22, 2019

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.

Locations