NCT05807282

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 17, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

farmworkerheat exposure

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 10 weeks

Secondary Outcomes (1)

  • Perceived heat stress (questionnaire)

    Up to 10 weeks

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Under age 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prfoessor

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 11, 2023

Study Start

July 16, 2023

Primary Completion

September 1, 2023

Study Completion

June 30, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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