NCT05265689

Brief Summary

This cluster randomized controlled trial will evaluate a community-based bicycle safety education program with and without an in-person parent training component. The investigators will recruit 180 early adolescent bicyclists (ages 9 to 12) and a parent/guardian from local neighborhood centers after school and summer programs, where the investigators have conducted preliminary studies. Randomization into the three study groups will occur at the site-level. Adolescent bicycles in all study group sites will be equipped with Pedal Portal, an innovative bicycle-mounted GPS/video system developed by the research team to objectively observe bicycling risk exposure and behaviors while bicycling. System data will be coded to measure bicycling exposure (hours, miles traveled, routes) and the types and rates of safety-relevant events (near crashes, crashes), and safety-relevant behaviors (e.g., following traffic rules, scanning for traffic at intersections). This will be the first randomized trial to use GPS and video technology to evaluate the effectiveness of a youth bicycle safety intervention in changing behavior. The control group will not receive any bicycle safety education programming. Participants in the first intervention group (Bike Club) will receive a 12-hour bicycle safety education program. Participants in the second intervention group (Bike Club Plus) will receive an enhanced version of the 12-hour bicycle safety education program which will include a parent training session on bicycling safety best practices, child development as it relates to bicycling, strategies for practice at home, and feedback on their adolescent's bicycling performance. The investigators' main hypotheses are that adolescents who receive the bicycle safety intervention will have increased safety behaviors (e.g., helmet use, hazard recognition), reduced errors (e.g., riding against traffic, swerving/wobbling), and increased knowledge, perceptions, and self-efficacy compared to the control group; and adolescents whose parent receives the parent training will have even greater improvements in study outcomes than those whose parents do not receive the training. If successful, approaches from this study could be widely implemented to improve adolescent bicycling safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 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

First Submitted

Initial submission to the registry

February 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

February 17, 2022

Last Update Submit

February 19, 2026

Conditions

PracticeSafetyBehaviorKnowledgeAdolescentSelf EfficacyEducationAttitudesBicycling

Keywords

cyclingbiketransportationinjury preventionintervention

Outcome Measures

Primary Outcomes (3)

  • Rate of safety-relevant events per 100 miles/minutes ridden

    Aim 1

    Two weeks of data collection within a six-month period

  • Rate of safety behaviors per 100 miles/minutes ridden

    Aim 1

    Two weeks of data collection within a six-month period

  • Proportion of positive and negative behaviors relative to the overall number of instances of a given event behavior

    Aim 1

    Two weeks of data collection within a six-month period

Secondary Outcomes (4)

  • Difference in knowledge tests scores

    Within a six month period

  • Difference in mean ratings of self-efficacy

    Within a six month period

  • Difference in mean ratings of perceptions

    Within a six month period

  • Difference in identification and recall of Cues to Action

    Within a six month period

Study Arms (3)

Bike Club

EXPERIMENTAL

Participants will receive a 12-hour bicycle safety education program

Behavioral: Bike Club

Bike Club Plus

EXPERIMENTAL

Participants will receive an enhanced version of the 12-hour bicycle safety education program which will include a parent training session on bicycling safety best practices, child development as it relates to bicycling, strategies for practice at home, and feedback on their adolescent's bicycling performance.

Behavioral: Bike Club Plus

Control Group

NO INTERVENTION

The control group will not receive any bicycle safety education programming.

Interventions

Bike ClubBEHAVIORAL

Administration of a bicycle safety education program to children ages 9-12 based on Let's Go NC!. Let's Go NC! includes observational skill checklists for instructors to track participant progress throughout the program, on-bicycle skills practice, hazard anticipation and avoidance, and traffic law importance and consequences. Additionally, participants will go on a "capstone ride" to practice their skills across varying transportation and recreation infrastructure and settings. The program will be administered at various sites across Iowa City.

Bike Club
Bike Club PlusBEHAVIORAL

Same as Bike Club, with the addition of a parent training component. Parents from these dyads will receive a training session on bicycling safety best practices, tips for practicing with their children at home, and feedback on how their child performed in the program (including areas in need of improvement).

Bike Club Plus

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 12 years old.
  • Lives in Johnson County, Iowa.
  • Willing to participate in bicycling safety education program.
  • Adolescent has access to a bicycle and rides independently at least 2 times per week.
  • Fluency in English for the adolescent.
  • Fluency in English, French, or Spanish for at least one parent/guardian.
  • No siblings already enrolled in the study (only one adolescent per family will be enrolled).
  • Adolescent has not previously completed a formal bicycle safety education program
  • Legal guardianship of adolescent by at least one participating adult (thus excluding wards of the state).

You may not qualify if:

  • Having a condition which would be a safety risk on a bicycle or performing physical activity, including but not limited to a seizure disorder or mobility issue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52245, United States

Location

Related Publications (1)

  • Hamann CJ, Dusil R, Rockwell LC, Spears S, Pae G, Ghanbari A, Peek-Asa C, Plumert JM, Cavanaugh JE. Protocol of a cluster-randomised trial to improve adolescent bicycling safety education programme efficacy. BMJ Public Health. 2024 Nov 20;2(2):e001059. doi: 10.1136/bmjph-2024-001059. eCollection 2024 Dec.

    PMID: 40018563DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

  • Cara Hamann, PHD

    University of Iowa College of Public Health; University of Iowa Injury Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 180 adolescent-parent dyads will be recruited from email listservs (University of Iowa, local school districts, other partner organization), community events (bike rodeos, outdoor markets, etc.), and local after school and summer programs affiliated with community neighborhood centers. Each site (cluster) will be randomly assigned to one of three study arms: 1) Bicycle safety education (Bike Club), 2) Bicycle safety education plus parent training session (Bike Club Plus), and 3) Control (no bicycle safety education or parent training session). Additional dyads may be recruited through other means, such as the University of Iowa listserv. Individuals recruited by these means would be randomly assigned to a study arm, based on the school they attend. A group bicycle safety education intervention will be delivered to adolescent participants at sites assigned the two intervention study arms (Bike Club and Bike Club Plus).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 3, 2022

Study Start

May 27, 2022

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Individual participant data that underlies published results will be shared after deidentification.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be made available after the main findings from the final research data set have been accepted for publication. No end date.
Access Criteria
Access to IPD can be requested by qualified researchers engaging in independent scientific research, and will be be disseminated in accordance with with University/Participating institutional and NIH policies, including entering into a Data Sharing Agreement. Inquiries for should be sent to cara-hamann@uiowa.edu.

Locations

US(1)