A Multilevel Intervention to Prevent Noise Exposure in Farmworkers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Diego State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Multilevel Hearing Protection Training
BehavioralThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervention Arm (Multilevel Intervention Group)Experimental treatment 1 intervention
Group B: Control Arm (Usual Practice)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and approximately 1 month post-intervention2
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.
Time frame
Baseline and approximately 1 month post-interventionSecondary outcomes
1
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.
Time frame
Baseline and approximately 1 month post-intervention2
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.
Time frame
Approximately 1 month post-intervention3
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.
Time frame
Approximately 1 month post-intervention4
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.
Time frame
Approximately 1 month post-interventionSponsors and contacts
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San Diego State University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov
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