Head InjuriesNCT01054846
Impact of Helmet Use in Preschool Children
A study testing Bicycle helmet from Bell Sports Inc. and Bicycle helmet education only in people with Head Injuries and Facial Injuries, run by Parkview Hospital, Indiana at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Head Injuries, Facial Injuries
- What is being tested?
- Bicycle helmet from Bell Sports Inc. and Bicycle helmet education only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Action of Northeast Indiana (CANI) Inc - Head Start
Fort Wayne, Indiana, 46802
About this study
Official title: 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
Read the 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).
- Conditions
- Head Injuries, Facial Injuries
- Being tested
- Bicycle helmet from Bell Sports Inc., Bicycle helmet education only
- Keywords
- Bicycle helmet
- Medical subject headings
- Craniocerebral Trauma, Facial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle helmet from Bell Sports Inc.Other
Also called Bell bicycle helmets
As described under the respective arm
Bicycle helmet education onlyOther
Also called Bicycle helmet education
As described under the respective arm
| Study group | Role | What they receive |
|---|---|---|
| Helmet and helmet education | Experimental | 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. Receives: Other: Bicycle helmet from Bell Sports Inc. |
| Helmet education | Active comparator | Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above. Receives: Other: Bicycle helmet education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Wearing Helmet
Measured: Baseline (Survey 1) and 5 months (Survey 2)
Secondary outcomes (1)
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Number of injuries by helmet wearing status as reported
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkview Hospital, Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thein H Zhu, Parkview Hospital, Indiana
- Investigators
- Mary O Aaland, MD, FACS, Study director, Parkview Hospital Trauma CenterThein H Zhu, MBBS, FACE, Principal investigator, Parkview Hospital Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054846
- Sponsor's protocol ID
- Parkview - 001
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2010
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana
- ClinicalTrials.gov ID
- NCT01054846
- Acronym / sponsor ID
- Parkview - 001
- Conditions
- Head Injuries, Facial Injuries
- Keywords
- Bicycle helmet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Parkview Hospital, IndianaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 18 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmet and helmet education | Experimental | Other: 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. |
| Helmet education | Active comparator | Other: Bicycle helmet education onlyEach child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicycle helmet from Bell Sports Inc.Also: Bell bicycle helmetsAs described under the respective arm | Other | Helmet and helmet education |
| Bicycle helmet education onlyAlso: Bicycle helmet educationAs described under the respective arm | Other | Helmet education |
Primary outcome
Percentage of Participants Wearing Helmet
Time frame: Baseline (Survey 1) and 5 months (Survey 2)
1 secondary outcome
Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationZhu 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
- Result Publication linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary O Aaland, MD, FACS study director
Parkview Hospital Trauma Center
Thein H Zhu, MBBS, FACE principal investigator
Parkview Hospital Trauma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicycle helmet from Bell Sports Inc. and Bicycle helmet education only in people with Head Injuries and Facial Injuries, run by Parkview Hospital, Indiana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Wearing Helmet (time frame: Baseline (Survey 1) and 5 months (Survey 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01054846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.