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Impact of Helmet Use in Preschool Children

Primary Purpose

Head Injuries, Facial Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bicycle helmet from Bell Sports Inc.
Bicycle helmet education only
Sponsored by
Parkview Hospital, Indiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head Injuries focused on measuring Bicycle helmet

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Action of Northeast Indiana (CANI) Inc - Head Start

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Helmet and helmet education

Helmet education

Arm Description

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.

Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.

Outcomes

Primary Outcome Measures

Percentage of Participants Wearing Helmet

Secondary Outcome Measures

Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Number of injuries by helmet wearing status as reported

Full Information

First Posted
January 21, 2010
Last Updated
February 7, 2017
Sponsor
Parkview Hospital, Indiana
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1. Study Identification

Unique Protocol Identification Number
NCT01054846
Brief Title
Impact of Helmet Use in Preschool Children
Official Title
The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parkview Hospital, Indiana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injuries, Facial Injuries
Keywords
Bicycle helmet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helmet and helmet education
Arm Type
Experimental
Arm Description
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.
Arm Title
Helmet education
Arm Type
Active Comparator
Arm Description
Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Intervention Type
Other
Intervention Name(s)
Bicycle helmet from Bell Sports Inc.
Other Intervention Name(s)
Bell bicycle helmets
Intervention Description
As described under the respective arm
Intervention Type
Other
Intervention Name(s)
Bicycle helmet education only
Other Intervention Name(s)
Bicycle helmet education
Intervention Description
As described under the respective arm
Primary Outcome Measure Information:
Title
Percentage of Participants Wearing Helmet
Time Frame
Baseline (Survey 1) and 5 months (Survey 2)
Secondary Outcome Measure Information:
Title
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Description
Number of injuries by helmet wearing status as reported
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O Aaland, MD, FACS
Organizational Affiliation
Parkview Hospital Trauma Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thein H Zhu, MBBS, FACE
Organizational Affiliation
Parkview Hospital Trauma Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Action of Northeast Indiana (CANI) Inc - Head Start
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46802
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Links:
URL
http://file.scirp.org/pdf/Health20111100001_27944712.pdf
Description
Result Publication link

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Impact of Helmet Use in Preschool Children

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