NCT01054846

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

November 18, 2016

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

January 21, 2010

Results QC Date

November 9, 2016

Last Update Submit

February 7, 2017

Conditions

Head InjuriesFacial Injuries

Keywords

Bicycle helmet

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Wearing Helmet

    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

    5 months

Study Arms (2)

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.

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.

Other: Bicycle helmet education only

Interventions

Bicycle helmet from Bell Sports Inc.OTHER

As described under the respective arm

Also known as: Bell bicycle helmets
Helmet and helmet education
Bicycle helmet education onlyOTHER

As described under the respective arm

Also known as: Bicycle helmet education
Helmet education

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than two or greater than 5-year olds
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Fort Wayne, Indiana, 46802, United States

Location

Related Publications (1)

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Craniocerebral TraumaFacial Injuries

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Results Point of Contact

Title
Thein Zhu
Organization
Parkview Health
thein.zhu@parkview.com
260-266-1279

Study Officials

  • Mary O Aaland, MD, FACS

    Parkview Hospital Trauma Center

    STUDY DIRECTOR

  • Thein H Zhu, MBBS, FACE

    Parkview Hospital Trauma Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trauma Epidemiologist

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

May 1, 2008

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

February 9, 2017

Results First Posted

November 18, 2016

Record last verified: 2017-02

Locations

US(1)