Impact of Helmet Use in Preschool Children

February 7, 2017 updated by: Thein H Zhu, Parkview Hospital, Indiana

The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana

  • To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
  • To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.

The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Study Type

Interventional

Enrollment (Actual)

609

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46802
        • Community Action of Northeast Indiana (CANI) Inc - Head Start

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
  • The child must possess a bicycle or a riding toy to ride
  • The child's caregiver speaks English or Spanish

Exclusion Criteria:

  • Age less than two or greater than 5-year olds
  • 3-5 year old children that do not own a bicycle or a riding toy to ride
  • The child's caregiver does not speak English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helmet and helmet education
Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Other: Bicycle helmet from Bell Sports Inc.
As described under the respective arm
Other Names:
  • Bell bicycle helmets
Active Comparator: Helmet education
Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Other: Bicycle helmet education only
As described under the respective arm
Other Names:
  • Bicycle helmet education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Wearing Helmet
Time Frame: Baseline (Survey 1) and 5 months (Survey 2)
Baseline (Survey 1) and 5 months (Survey 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Time Frame: 5 months
Number of injuries by helmet wearing status as reported
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkview Hospital, Indiana

Investigators

  • Study Director: Mary O Aaland, MD, FACS, Parkview Hospital Trauma Center
  • Principal Investigator: Thein H Zhu, MBBS, FACE, Parkview Hospital Trauma Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Zhu TH; Aaland MO; Kerrigan C; Schiebel R; Henry H; Hollister L. Preventable head and facial injuries by providing free bicycle helmets and education to preschool children in a head start program. Health 2011 3(11):689-97

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parkview - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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