A Multilevel Intervention to Prevent Noise Exposure in Farmworkers

NCT07554378 | Not Yet Recruiting

• 2 other identifiers: IRB-26-1811K23DC022303-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time. Farms will be randomly assigned to either receive the program or serve as a comparison group. The program includes a short educational video, group discussion, and hands-on training on how to use hearing protection (such as earplugs). Supervisors will also receive brief training on how to support hearing protection use in the workplace. Participants will wear a small device (dosimeter) during a work shift to measure noise exposure before the program and again about one month later. Participants will also complete surveys about their knowledge, attitudes, and behaviors related to hearing protection. A subset of participants will be invited to take part in interviews to understand barriers and facilitators to using hearing protection and implementing the program. The results of this study will help inform future efforts to improve hearing health and reduce noise exposure in agricultural settings.

Conditions

Noise Exposure; Occupational Exposure; Hearing Loss, Noise-Induced

Keywords

farmworkers; agriculture; hearing protection; earplugs; occupational noise; hearing conservation; implementation science; Community Health Workers; Workplace intervention; Cluster randomized trial

Outcome Measures

Primary Outcomes (2)

• Change in Time-Weighted Average Noise Exposure (dBA)

  Objective occupational noise exposure measured using personal dosimeters worn during a full work shift. The primary metric is time-weighted average (TWA) noise exposure in decibels (dBA), calculated using standard NIOSH criteria. Devices do not record audio, only noise levels.

  Baseline and approximately 1 month post-intervention

• Change in Noise Dose (%)

  Cumulative occupational noise exposure measured as percent noise dose using personal dosimeters worn during a full work shift, calculated using standard NIOSH criteria.

  Baseline and approximately 1 month post-intervention

Secondary Outcomes (4)

• Change in Hearing Protection Beliefs and Attitudes

  Baseline and approximately 1 month post-intervention

• Acceptability of the Hearing Protection Training

  Approximately 1 month post-intervention

• Appropriateness of the Hearing Protection Training

  Approximately 1 month post-intervention

• Feasibility of the Hearing Protection Training

  Approximately 1 month post-intervention

Study Arms (2)

Intervention Arm (Multilevel Intervention Group)

EXPERIMENTAL

Participants at farms assigned to the intervention arm will receive a multilevel intervention that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on training on proper use of hearing protection (e.g., earplugs). Supervisors will receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is delivered in a community or workplace setting by trained study staff or community health workers.

Behavioral: Multilevel Hearing Protection Training

Control Arm (Usual Practice)

NO INTERVENTION

Participants at farms assigned to the control arm will not receive the intervention during the study period. They will complete study assessments, including dosimetry and surveys. The intervention will be offered after study completion.

Interventions

Multilevel Hearing Protection Training BEHAVIORAL

The intervention is a multilevel behavioral training program designed to reduce occupational noise exposure and promote hearing protection use. Farmworkers participate in a session that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on instruction on proper use of hearing protection (e.g., earplugs). Supervisors receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is intended to be delivered in a group or 1:1 setting by trained research staff or community health workers.

Also known as: Protected Ears Project (PEP)

Intervention Arm (Multilevel Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Currently employed as a farmworker or supervisor at a participating farm
• Able to provide informed consent
• Able to understand and communicate in Spanish or English

You may not qualify if:

• Not currently working at a participating farm at the time of recruitment
• Unable or unwilling to wear a personal noise dosimeter during a work shift
• Unable to complete study procedures (e.g., surveys or training)

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura Coco, PhD, AuD

CONTACT

16195943151; lcoco@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Farms are randomized in a 1:1 ratio to intervention or control conditions, with randomization occurring at the cluster (farm) level prior to participant recruitment. All eligible participants within each farm receive the condition assigned to that farm. Outcomes are assessed at baseline and approximately one month post-intervention. This cluster randomized, parallel-group design is used to minimize contamination between participants within the same worksite.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): July 1, 2032
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)