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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DC022303-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Protection Beliefs and Attitudes | Change in self-reported beliefs and attitudes toward hearing protection use, assessed using the 14-item Hearing Protection Beliefs scale. Items are rated on a 4-point Likert scale (1 = disagree to 4 = strongly agree) and summed after reverse-coding negatively worded items. Total scores range from 14 to 56, with higher scores indicating more favorable and accurate beliefs about hearing protection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Coco, PhD, AuD | Contact | 16195943151 | lcoco@sdsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | San Diego | California | 92182 | United States |
De-identified individual participant data may be shared in the future with qualified researchers upon reasonable request, subject to appropriate data use agreements and protections for participant confidentiality. Due to the small sample size and recruitment within specific worksites, there is a potential risk of re-identification; therefore, data will not be publicly posted and will only be shared in a controlled manner.
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| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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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.
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| Baseline and approximately 1 month post-intervention |
| Acceptability of the Hearing Protection Training | Participant-reported acceptability of the training assessed immediately post-training using the Acceptability of Intervention Measure (AIM). The AIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the training. | Approximately 1 month post-intervention |
| Appropriateness of the Hearing Protection Training | Participant-reported appropriateness of the training assessed immediately post-training using the Intervention Appropriateness Measure (IAM). The IAM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived appropriateness of the training. | Approximately 1 month post-intervention |
| Feasibility of the Hearing Protection Training | Participant-reported feasibility of the training assessed immediately post-training using the Feasibility of Intervention Measure (FIM). The FIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived feasibility of the training. | Approximately 1 month post-intervention |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |