Interventions to Decrease Heat Stress Among Latinx Farmworkers in Idaho

October 26, 2023 updated by: Carly Hyland, Boise State University
The goal of this study is to collaborate with farmworker, community organizations, and labor contractors/employers to develop workplace- and individual-level interventions, and evaluate the efficacy of those interventions in decreasing physiological and perceived heat stress among Latinx farmworkers in Idaho.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Occupational heat exposure presents one of the clearest acute and long-term health threats to farmworkers and will continue to worsen under climate change. Exposure to extreme heat can lead to Heat-Related Illnesses (HRI), a continuum of diseases that can range from mild symptoms (e.g., dizziness, fatigue, vomiting) to severe and life-threatening conditions including convulsions, coma, and even death. It is becoming increasingly urgent to identify effective strategies to prevent the health impacts of heat exposure among farmworkers as climate change increases the frequency, intensity, and duration of heat waves. The few studies that have examined this topic have identified some beneficial impacts of increasing access to cold water and shade at the workplace, however studies to date have been limited by their investigation of individual- and workplace- interventions in isolation and research teams that do not engage farmworkers and community-based organizations. Further, the studies that have been conducted have taken place primarily in states with regulations that prohibit work over a specific heat index, and it is important to examine the impacts of interventions to decrease heat stress in states without these regulations, such as Idaho. The aims of this study are to collaborate with farmworkers, farmworker employers, and community organizations to develop and evaluate the efficacy of multi-level interventions in mitigating physiological and perceived heat strain among Latinx farmworkers in Idaho. The investigators further aim to examine the efficacy of educational programs (e.g., training in identifying and preventing personal and occupational risk factors for heat stress) on knowledge, behaviors, and perceptions. Leveraging our existing and well-established relationships with multiple community partners, the investigators will disseminate the research findings and promote the implementation of health-protective heat interventions to farmworkers, farmworker employers, and stakeholders across Idaho and the Mountain West. This study was motivated by concerns voiced by participants in a previous study of Latinx farmworkers led by the current team of researchers and community organizations. Here, the investigators aim to respond directly to their stated concerns regarding occupational heat exposure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Identify as Hispanic/Latinx, currently working in an agricultural field in Idaho

Exclusion Criteria:

  • Under age 18 years

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
40 farmworkers will be randomized to receive the workplace- and individual-level interventions developed in collaboration with study partners (e.g., provision of hydration packs to participants). Participants will receive the intervention at the workplace and will be monitored for five weeks after the intervention to evaluate the efficacy in reducing perceived and physiological heat stress.
Other: Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho
The interventions will be developed in collaboration with our study partners and will include increasing access to shade at the workplace, providing hydration packs to participants, and providing education regarding the signs and symptoms of occupational heat stress.
No Intervention: Control group
40 farmworkers will be randomized to receive no intervention, and will continue their work as normal. These farmworkers will be monitored for the same period as the intervention group to assess perceived and physiological heat stress.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: Up to 10 weeks
The investigators will use sensors to monitor participants' body temperature as a sign of physiological heat stress. The investigators will compare differences in physiological heat stress between the control and intervention groups.
Up to 10 weeks
Heart rate
Time Frame: Up to 10 weeks
The investigators will use sensors to monitor participants' heart rate as a sign of physiological heat stress. The investigators will compare differences in physiological heat stress between the control and intervention groups.
Up to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived heat stress (questionnaire)
Time Frame: Up to 10 weeks
The investigators will administer weekly questionnaires assessing participants' perceived heat stress (e.g., self-report of nausea, vomiting and fatigue). The investigators will assess 15 symptoms and compare differences in the number of symptoms reported between the control and intervention groups.
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boise State University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BoiseSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to protect the confidentiality of this structurally marginalized population, data from this study will not be shared with outside investigators.

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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