Cooling Solutions for Outdoor Workers

NCT ID: NCT06998667

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2026-01-15

Brief Summary

The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.

Detailed Description

Workers in a variety of US industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. The investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. This work will enhance worker safety using evidence-based technology.

To accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. Over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). Secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.

Conditions

Hyperthermia; Heat Acclimation and Thermotolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Heat Illness Prevention

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks.

Group Type: ACTIVE_COMPARATOR

Standard Heat Illness Prevention Measures

Intervention Type: BEHAVIORAL

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks

Cooling bandana with Standard Heat Illness Prevention Measures

Provision of a bandana with slow-evaporation polymer for use during work, in addition to standard CAL-OSHA workplace heat illness prevention interventions

Group Type: EXPERIMENTAL

Standard Heat Illness Prevention Measures

Intervention Type: BEHAVIORAL

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks

Cooling bandana

Intervention Type: OTHER

Cooling bandana embedded with a polymer to slow evaporation

Cooling glove with standard Heat Illness Prevention

Provision of a glove with ability to circulate cool water, for use during breaks, in addition to standard CAL-OSHA workplace heat illness prevention interventions

Group Type: EXPERIMENTAL

Standard Heat Illness Prevention Measures

Intervention Type: BEHAVIORAL

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks

Cooling glove

Intervention Type: OTHER

Cooling glove with ability to circulate cool water interface with palmar skin

Interventions

Standard Heat Illness Prevention Measures

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks

Intervention Type: BEHAVIORAL

Cooling bandana

Cooling bandana embedded with a polymer to slow evaporation

Intervention Type: OTHER

Cooling glove

Cooling glove with ability to circulate cool water interface with palmar skin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18

2. Anticipated to be working in the same job category for the duration of the study

3. Able to communicate in English or Spanish

Exclusion Criteria

1. Cannot provide informed consent

2. Weight less than 40 kg

3. Inability to swallow pills

4. Known history of having a pacemaker or ICD

5. Pregnancy as determined by self report and confirmed on Day 1

6. Gastrointestinal disorders (e.g., gastroparesis, prior surgery on GI tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease)

7. Plan for an elective MRI in the 7 days post last planned pill ingestion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Shuchi Anand

Associate Professor in Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuchi Anand, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Julie Parsonnet, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Maria Montez Rath, mrath@stanford.edu

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

80246

Identifier Type: -

Identifier Source: org_study_id