- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05807282
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
Withdrawn
Conditions
Intervention / Treatment
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
Interventional
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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)
July 16, 2023
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
March 17, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 11, 2023
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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