Facial Injuries, Head Injuries
Conditions
Keywords
Bicycle helmet
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).
Interventions
OTHERBicycle helmet from Bell Sports Inc.
As described under the respective arm
OTHERBicycle helmet education only
As described under the respective arm
Sponsors
Parkview Hospital, Indiana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Wearing Helmet | Baseline (Survey 1) and 5 months (Survey 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
609 participants were enrolled in the study and 2 were later known that they did not meet study inclusion criteria.
Pre-assignment details
Although 285 received Helmet Education only, 68 participants had prior helmet ownership and therefore were considered for further analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Bicycle helmet from Bell Sports Inc.: As described under the respective arm | 322 |
| 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.
Bicycle helmet education only: As described under the respective arm | 68 |
| Total | 390 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 76 | 17 |
Baseline characteristics
| Characteristic | Helmet and Helmet Education | Helmet Education | Total |
|---|---|---|---|
| Age, Customized 3 years | 87 Participants | 12 Participants | 99 Participants |
| Age, Customized 4 years | 125 Participants | 33 Participants | 158 Participants |
| Age, Customized 5 years | 110 Participants | 23 Participants | 133 Participants |
| Sex: Female, Male Female | 161 Participants | 38 Participants | 199 Participants |
| Sex: Female, Male Male | 161 Participants | 30 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 9 / 607 |
Outcome results
Primary
Percentage of Participants Wearing Helmet
Time frame: Baseline (Survey 1) and 5 months (Survey 2)
Population: Analysis reflect population that owned the helmet during each survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helmet and Helmet Education | Percentage of Participants Wearing Helmet | Baseline (Survey 1, n=99, 67) | 65.6 Percentage of Participants |
| Helmet and Helmet Education | Percentage of Participants Wearing Helmet | 5 months (Survey 2, n=221, 45) | 80.5 Percentage of Participants |
| Helmet Education | Percentage of Participants Wearing Helmet | 5 months (Survey 2, n=221, 45) | 62.2 Percentage of Participants |
| Helmet Education | Percentage of Participants Wearing Helmet | Baseline (Survey 1, n=99, 67) | 49.3 Percentage of Participants |
Comparison: Differences between Survey 1 and Survey 2p-value: <0.01Chi-squared
Comparison: Difference between Survey 1 and Survey 2p-value: >0.05Chi-squared
Secondary
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Number of injuries by helmet wearing status as reported
Time frame: 5 months
Population: Analysis population includes all participants that owned a helmet and available data for this assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Face - all portions) | 12 Injuries |
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Head injuries) | 8 Injuries |
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Head injuries) | 2 Injuries |
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Face - upper/mid) | 3 Injuries |
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Face - upper/mid) | 3 Injuries |
| Helmet and Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Face - all portions) | 8 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Face - upper/mid) | 1 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Head injuries) | 0 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Face - all portions) | 3 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Helmet riders (Face - upper/mid) | 1 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Head injuries) | 2 Injuries |
| Helmet Education | Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Non-Helmeted riders (Face - all portions) | 3 Injuries |