Heat Stress DisordersNCT04234802
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
A study testing Heat Education and Awareness Tools in people with Heat Stress Disorders, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heat Stress Disorders
- What is being tested?
- Heat Education and Awareness Tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to 30 Sep 2021
- 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
- Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Heat Stress Disorders
- Being tested
- Heat Education and Awareness Tools
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Education and Awareness ToolsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately three months
Secondary outcomes (2)
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.
Measured: Approximately three months
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
Measured: Approximately three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start22 May 2019
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heat Stress DisordersStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, June Spector, University of Washington
- Investigators
- June T Spector, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234802
- Sponsor's protocol ID
- STUDY00000238
- Other IDs
- 2U54OH007544-16
- Status last verified
- May 2022
- First submitted
- 14 Jan 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36104813Marquez 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.
PubMed 35345983Krenz 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.
PubMed 34169175
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
- ClinicalTrials.gov ID
- NCT04234802
- Acronym / sponsor ID
- STUDY00000238
- Conditions
- Heat Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Jan 2020 (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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEAT intervention group | Active comparator | Other: Heat Education and Awareness ToolsWorkers 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Heat Education and Awareness ToolsHEAT 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. | Other | HEAT intervention group |
Primary outcome
Heat-related Illness Symptoms
Time frame: Approximately three months
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
Time frame: Approximately three months
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.
2 secondary outcomes
Pre/post Knowledge Assessment
Time frame: Approximately three months
Pre/post Supervisor Survey
Time frame: Approximately three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 36104813Chavez 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.
- Derived from this study: PubMed 35345983Marquez 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.
- Derived from this study: PubMed 34169175Krenz 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
June T Spector, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Education and Awareness Tools in people with Heat Stress Disorders, run by University of Washington at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heat-related Illness Symptoms (time frame: Approximately three months). 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?
On the ClinicalTrials.gov record for NCT04234802, which also lists 3 linked publications.
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 17 May 2022.