BicyclingNCT05265689
Study to Improve Adolescent Bicycling Safety
A study testing Bike Club and Bike Club Plus in people with Bicycling and Knowledge, run by Cara J. Hamann at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bicycling, Knowledge, Adolescent
- What is being tested?
- Bike Club and Bike Club Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9 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.
Show all 9Show fewer
- 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).
Who cannot join
- Does not agree to or meet one or more of the inclusion criteria
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Trial to Improve Adolescent Bicycling Safety
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.
Read the detailed description
Following consent process, the study protocol will go as follows:
Step 1. Initial meeting Baseline Survey: At the time of in-person assent/consent each dyad (parent and child) will complete a paper-based baseline survey (demographics, cycling and driving experience, etc). Participants will also be given the option to sign a video/audio release waiver that allows use of recordings obtained during the research to be used for educations purposes outside of the research study itself. Participants will be instructed to record trips (video/audio/GPS) only on public roads. A research assistant will be available to answer any questions about the study and/or survey. This is expected to take 20 minutes.
Instrumentation and data collection: Instructions and set-up of equipment (combined camera/GPS system and backup GPS system) will be done at an agreed upon time before the start of the first one-week data collection period. The combined camera/GPS system will be attached to the participant's bicycle handlebar using a mount supplied by the manufacturer. The backup GPS system will be attached to the handlebars, under the seat, or elsewhere on the bike frame. Participants will be instructed on how to turn the device on/off at the beginning and end of each ride. This setup and instruction is expected to take 30-45 minutes. Information manuals will be left with the participant during the study period for their reference. The research assistants will be available to participants via email, telephone, or in-person during the study period to provide technical assistance.
Step 2. Pre-intervention/Baseline riding data collection: Child participants will ride their bicycles as they normally would during the baseline 1-week observation period. No route or time will be specified. The camera/GPS will turn on automatically at the start of each ride and off again at the end of the ride. Participants will also be asked to keep a paper-based trip diary that includes a log of each trip, the trip purpose, the date, time of day, and any incidents that occur.
Step 3. Equipment and trip diary collection: During the time period between the consecutive data collection weeks, research staff will meet with participants to collect the trip diary and camera/GPS from the first observation period. Participants will be given a blank trip diary for use in the second observation period.
Step 4. Intervention delivery-- Bike Club [Applies to two intervention groups only]
Step 5. Post-intervention/Follow-up riding data collection: Child participants will ride their bicycles during the second one-week observation period. No route or time will be specified. The camera/GPS will turn on automatically at the start of each ride and off again at the end of the ride. Participants will also be asked to keep a paper-based trip diary that includes a log of each trip, the trip purpose, the date, time of day, comfort rating, and any incidents that occur.
Step 6. End of study meeting Follow-up surveys: Follow-up surveys will be administered to dyads (parent and child) during the last in-person meeting after the post-intervention one-week naturalistic data collection period.
The research team will also pick up the camera/GPS equipment and trip diary from the participants. At this meeting, participation in the study will be complete.
Step 7. All data collected will be downloaded from the devices (combined camera/gps system, backup GPS system, digital survey responses) and stored on a password-protected university hard drive accessible only to research personnel. Paper survey responses will be manually entered into a database stored on the same drive. Video obtained from the cameras will be used to examine roadway conditions, rider safety behaviors, and interactions with other road users. Videos will also be used to analyze safety-relevant events (crashes, near-crashes, etc.) that are identified by the participant or research personnel. Video recording is a required portion of the study. However, participants must opt in to allow the use of video for non-research educational purposes by signing the release form provided during the consent process. Videos will be retained for a minimum of 3 years with the rest of the project data.
- Conditions
- Bicycling, Knowledge, Adolescent, Self Efficacy, Education, Attitudes
- Being tested
- Bike Club, Bike Club Plus
- Keywords
- cycling, bike, transportation, injury prevention, intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bike ClubBehavioural
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 PlusBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Bike Club | Experimental | Participants will receive a 12-hour bicycle safety education program Receives: 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. Receives: Behavioral: Bike Club Plus |
| Control Group | No intervention | The control group will not receive any bicycle safety education programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of safety-relevant events per 100 miles/minutes ridden
Aim 1
Measured: Two weeks of data collection within a six-month period
Rate of safety behaviors per 100 miles/minutes ridden
Aim 1
Measured: 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
Measured: Two weeks of data collection within a six-month period
Secondary outcomes (4)
Difference in knowledge tests scores
Aim 2 - From baseline survey to follow-up survey (Likert Scale, Higher score means better outcome)
Measured: Within a six month period
Difference in mean ratings of self-efficacy
Aim 2 - From baseline survey to follow-up survey (Likert Scale, Higher score means better outcome)
Measured: Within a six month period
Difference in mean ratings of perceptions
Aim 2 - From baseline survey to follow-up survey (Likert Scale, Higher score means better outcome)
Measured: Within a six month period
Difference in identification and recall of Cues to Action
Aim 2 - From baseline survey to follow-up survey (Recall: Yes or No, Identification: Multiple Choice)
Measured: Within a six month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start27 May 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BicyclingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara J. Hamann
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Cara J. Hamann, University of Iowa
- Investigators
- Cara Hamann, PHD, Principal investigator, University of Iowa College of Public Health; University of Iowa Injury Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265689
- Sponsor's protocol ID
- 202105148
- Other IDs
- R01HD102402
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies published results will be shared after deidentification.
Publications
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.
PubMed 40018563
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial to Improve Adolescent Bicycling Safety
- ClinicalTrials.gov ID
- NCT05265689
- Acronym / sponsor ID
- 202105148
- Conditions
- Bicycling, Knowledge, Adolescent, Self Efficacy, Education, Attitudes
- Keywords
- cycling, bike, transportation, injury prevention, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Cara J. HamannUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following consent process, the study protocol will go as follows:
Step 1. Initial meeting Baseline Survey: At the time of in-person assent/consent each dyad (parent and child) will complete a paper-based baseline survey (demographics, cycling and driving experience, etc). Participants will also be given the option to sign a video/audio release waiver that allows use of recordings obtained during the research to be used for educations purposes outside of the research study itself. Participants will be instructed to record trips (video/audio/GPS) only on public roads. A research assistant will be available to answer any questions about the study and/or survey. This is expected to take 20 minutes.
Instrumentation and data collection: Instructions and set-up of equipment (combined camera/GPS system and backup GPS system) will be done at an agreed upon time before the start of the first one-week data collection period. The combined camera/GPS system will be attached to the participant's bicycle handlebar using a mount supplied by the manufacturer. The backup GPS system will be attached to the handlebars, under the seat, or elsewhere on the bike frame. Participants will be instructed on how to turn the device on/off at the beginning and end of each ride. This setup and instruction is expected to take 30-45 minutes. Information manuals will be left with the participant during the study period for their reference. The research assistants will be available to participants via email, telephone, or in-person during the study period to provide technical assistance.
Step 2. Pre-intervention/Baseline riding data collection: Child participants will ride their bicycles as they normally would during the baseline 1-week observation period. No route or time will be specified. The camera/GPS will turn on automatically at the start of each ride and off again at the end of the ride. Participants will also be asked to keep a paper-based trip diary that includes a log of each trip, the trip purpose, the date, time of day, and any incidents that occur.
Step 3. Equipment and trip diary collection: During the time period between the consecutive data collection weeks, research staff will meet with participants to collect the trip diary and camera/GPS from the first observation period. Participants will be given a blank trip diary for use in the second observation period.
Step 4. Intervention delivery-- Bike Club [Applies to two intervention groups only]
Step 5. Post-intervention/Follow-up riding data collection: Child participants will ride their bicycles during the second one-week observation period. No route or time will be specified. The camera/GPS will turn on automatically at the start of each ride and off again at the end of the ride. Participants will also be asked to keep a paper-based trip diary that includes a log of each trip, the trip purpose, the date, time of day, comfort rating, and any incidents that occur.
Step 6. End of study meeting Follow-up surveys: Follow-up surveys will be administered to dyads (parent and child) during the last in-person meeting after the post-intervention one-week naturalistic data collection period.
The research team will also pick up the camera/GPS equipment and trip diary from the participants. At this meeting, participation in the study will be complete.
Step 7. All data collected will be downloaded from the devices (combined camera/gps system, backup GPS system, digital survey responses) and stored on a password-protected university hard drive accessible only to research personnel. Paper survey responses will be manually entered into a database stored on the same drive. Video obtained from the cameras will be used to examine roadway conditions, rider safety behaviors, and interactions with other road users. Videos will also be used to analyze safety-relevant events (crashes, near-crashes, etc.) that are identified by the participant or research personnel. Video recording is a required portion of the study. However, participants must opt in to allow the use of video for non-research educational purposes by signing the release form provided during the consent process. Videos will be retained for a minimum of 3 years with the rest of the project data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Bike Club | Experimental | Behavioral: Bike ClubParticipants will receive a 12-hour bicycle safety education program |
| Bike Club Plus | Experimental | Behavioral: Bike Club PlusParticipants 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. |
| Control Group | No intervention | –The control group will not receive any bicycle safety education programming. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 9 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.
Key exclusion criteria (2 listed)
- Does not agree to or meet one or more of the inclusion criteria
- 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.
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 |
|---|---|---|
| Bike ClubAdministration 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. | Behavioural | Bike Club |
| Bike Club PlusSame 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). | Behavioural | Bike Club Plus |
Primary outcome
Rate of safety-relevant events per 100 miles/minutes ridden
Time frame: Two weeks of data collection within a six-month period
Aim 1
Rate of safety behaviors per 100 miles/minutes ridden
Time frame: Two weeks of data collection within a six-month period
Aim 1
Proportion of positive and negative behaviors relative to the overall number of instances of a given event behavior
Time frame: Two weeks of data collection within a six-month period
Aim 1
4 secondary outcomes
Difference in knowledge tests scores
Time frame: Within a six month period
Difference in mean ratings of self-efficacy
Time frame: Within a six month period
Difference in mean ratings of perceptions
Time frame: Within a six month period
Difference in identification and recall of Cues to Action
Time frame: Within a six month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Derived from this study: PubMed 40018563Hamann 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies published results will be shared after deidentification.
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Recruiting
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Older Adults, Exercise Training
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.
Cara Hamann, PHD principal investigator
University of Iowa College of Public Health; University of Iowa Injury Prevention Research 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 Bike Club and Bike Club Plus in people with Bicycling and Knowledge, run by Cara J. Hamann 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 9 inclusion and 2 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 20 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of safety-relevant events per 100 miles/minutes ridden (time frame: Two weeks of data collection within a six-month period). The study lists 3 primary outcomes in all. 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 NCT05265689, 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 20 Feb 2026.