Environmental ExposureNCT05807282
Interventions to Decrease Heat Stress Among Latinx Farmworkers in Idaho
A study testing Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho in people with Environmental Exposure, run by Boise State University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as Hispanic/Latinx, currently working in an agricultural field in Idaho
Who cannot join
- Under age 18 years
About this study
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.
Read the 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.
- Conditions
- Environmental Exposure
- Being tested
- Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho
- Keywords
- farmworker, heat exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions to Decrease Heat Stress among Latinx Farmworkers in IdahoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
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.
Measured: Up to 10 weeks
Heart rate
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.
Measured: Up to 10 weeks
Secondary outcomes (1)
Perceived heat stress (questionnaire)
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.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start16 Jul 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Study was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 farmworkers identifying as Hispanic/Latinx will be randomized to one of two treatment arms: 1) individual- and workplace-level interventions to decrease the health impacts of occupational heat stress, or 2) control.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boise State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Hyland, Boise State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807282
- Sponsor's protocol ID
- BoiseSU
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the confidentiality of this structurally marginalized population, data from this study will not be shared with outside investigators.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Decrease Heat Stress Among Latinx Farmworkers in Idaho
- ClinicalTrials.gov ID
- NCT05807282
- Acronym / sponsor ID
- BoiseSU
- Conditions
- Environmental Exposure
- Keywords
- farmworker, heat exposure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boise State UniversityUniversity, hospital or other
- Study start
- 16 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80 farmworkers identifying as Hispanic/Latinx will be randomized to one of two treatment arms: 1) individual- and workplace-level interventions to decrease the health impacts of occupational heat stress, or 2) control.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho40 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Identify as Hispanic/Latinx, currently working in an agricultural field in Idaho
Key exclusion criteria (1 listed)
- Under age 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventions to Decrease Heat Stress among Latinx Farmworkers in IdahoThe 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. | Other | Intervention group |
Primary outcome
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.
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.
1 secondary outcome
Perceived heat stress (questionnaire)
Time frame: Up to 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No. In order to protect the confidentiality of this structurally marginalized population, data from this study will not be shared with outside investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions to Decrease Heat Stress among Latinx Farmworkers in Idaho in people with Environmental Exposure, run by Boise State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: Up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.