NCT02472821

Brief Summary

Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There is a lack of programs to prepare this high-risk population to use hearing conservation strategies. This randomly-controlled trial of innovative community-based interventions is designed to compare effectiveness and sustainability of approaches to increase youths' use of hearing conservation strategies. Consistent use of hearing conservation strategies is expected to reduce rates of NIHL and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,093

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2016

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

June 9, 2015

Last Update Submit

February 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported use of hearing conservation strategies (i.e., using hearing protection devices, walking away from hazardous noise, or turning down sources of hazardous noise) when in high noise

    12 months

Secondary Outcomes (2)

  • Cost effectiveness

    12 months

  • Sustainability

    12 months

Study Arms (3)

Interactive Lesson

ACTIVE COMPARATOR

Subjects will receive a community-based face-to-face interactive youth educational program on hearing health

Behavioral: Interactive youth educational program

Interactive lesson + Web-based booster

ACTIVE COMPARATOR

Subjects will receive a community-based face-to-face interactive youth educational program on hearing health followed by an Internet-based educational booster

Behavioral: Interactive youth educational programBehavioral: Internet-based educational booster

No-intervention control

NO INTERVENTION

No interventions; pre- and post- measures only.

Interventions

Participation in a community-based face-to-face interactive youth educational program focusing on hearing health (i.e., noise hazards, risk of noise-induced hearing loss, mechanism of injury to the internal ear, and preventive measures)

Also known as: Progressive Agriculture Foundation Safety Days
Interactive LessonInteractive lesson + Web-based booster

Visit to an educational Web site focused on hearing health

Also known as: Dangerous Decibels Virtual Exhibit
Interactive lesson + Web-based booster

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • enrollment in grade 4
  • parental consent
  • English speaking
  • attending a Safety Days event included in the cluster sampling

You may not qualify if:

  • (none)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • McCullagh MC, Banerjee T, Yang J. Protocol of a test of hearing health education programs for farm and rural youth. BMC Public Health. 2015 Oct 16;15:1061. doi: 10.1186/s12889-015-2393-y.

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marjorie C McCullagh, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 16, 2015

Study Start

February 17, 2015

Primary Completion

December 19, 2016

Study Completion

December 19, 2016

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations