Impact of Helmet Use in Preschool Children

Not Applicable

Completed

• Conditions: Head Injuries; Facial Injuries
• Interventions: Other: Bicycle helmet education only; Other: Bicycle helmet from Bell Sports Inc.

• Registration Number: NCT01054846
• Lead Sponsor: Parkview Hospital, Indiana

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).

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-11
• Study Completion: 2009-01
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Results First Submitted: 2016-11-09
• Results First Submitted QC: 2016-11-09
• Results First Posted: 2016-11-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet education	Bicycle helmet education only	Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Helmet and helmet education	Bicycle helmet from Bell Sports Inc.	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Wearing Helmet	Baseline (Survey 1) and 5 months (Survey 2)

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners	5 months	Number of injuries by helmet wearing status as reported

Trial Locations

Locations (1)

Community Action of Northeast Indiana (CANI) Inc - Head Start; 🇺🇸 Fort Wayne, Indiana, United States