| Registry | NCT07554378, acronym POP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 200 (Estimated) |
| Sponsor | San Diego State University (Other); collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Conditions | Noise Exposure, Hearing Loss, Noise-Induced, Occupational Exposure |
| Interventions | Multilevel Hearing Protection Training (Behavioral) |
| Dates | start 2026-10-01 (estimated), primary completion 2031-01-01 (estimated), completion 2032-07-01 (estimated), first posted 2026-04-28, last updated 2026-04-28 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Noise Exposure All trials for Hearing Loss, Noise-Induced All trials of Multilevel Hearing Protection Training
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.
This study is a cluster randomized controlled trial designed to evaluate a multilevel intervention to reduce occupational noise exposure among farmworkers. Farms will be recruited through community and industry partnerships and randomized in a 1:1 ratio to either the intervention or control condition. Randomization will occur at the farm level to minimize contamination.
The intervention includes both worker- and supervisor-level components. Farmworkers will participate in a training session consisting of a brief educational video on noise exposure and hearing loss, followed by group discussion and hands-on instruction on proper use of hearing protection. Supervisors will receive a brief training focused on identifying noise hazards, promoting hearing protection use, and supporting workplace-level safety practices.
Control sites will not receive the intervention during the study period but will be offered the program after study completion.
Primary outcomes include objective measures of noise exposure assessed using personal dosimeters worn during a full work shift at baseline and approximately one month post-intervention. Dosimeters measure time-weighted average noise exposure, noise dose, and peak sound levels and do not record audio.
Secondary outcomes include farmworker knowledge, attitudes, self-efficacy, and behaviors related to hearing protection, as well as supervisor-level outcomes related to supporting hearing safety. Worksite-level outcomes include availability of hearing protection and presence of noise hazard indicators.
A qualitative component will be conducted with a subset of participants, including farmworkers, supervisors, and external stakeholders, to assess barriers and facilitators to implementation. Interviews will be conducted in participants' preferred language, audio-recorded with consent, and analyzed using established implementation science frameworks.
This study will provide preliminary evidence on the effectiveness and feasibility of a multilevel intervention to reduce noise exposure in agricultural settings and inform future large-scale trials.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Arm (Multilevel Intervention Group) | Experimental | Behavioral: Multilevel Hearing Protection Training | 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. |
| 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
| Facility | City | Country | Status |
|---|---|---|---|
| San Diego State University | San Diego, California | United States |
NIH grants: K23DC022303