A Cluster Randomized Trial to Improve Adolescent Bicycling Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Rate of safety behaviors per 100 miles/minutes ridden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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).
排除标准
- •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.
研究组 & 干预措施
Bike Club
Participants will receive a 12-hour bicycle safety education program
干预措施: Bike Club (Behavioral)
Bike Club Plus
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.
干预措施: Bike Club Plus (Behavioral)
Control Group
The control group will not receive any bicycle safety education programming.
结局指标
主要结局
Rate of safety behaviors per 100 miles/minutes ridden
时间窗: 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
时间窗: Two weeks of data collection within a six-month period
Aim 1
Rate of safety-relevant events per 100 miles/minutes ridden
时间窗: Two weeks of data collection within a six-month period
Aim 1
次要结局
- Difference in mean ratings of self-efficacy(Within a six month period)
- Difference in identification and recall of Cues to Action(Within a six month period)
- Difference in knowledge tests scores(Within a six month period)
- Difference in mean ratings of perceptions(Within a six month period)
研究者
Cara J. Hamann
Assistant Professor
University of Iowa