Pilot and Feasibility Bicycle Train Study

NCT02006186 | Completed DMC

• 1 other identifier: R21HL113810
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and related chronic disease risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020. The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors. Our Specific Aims will be to: SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if: FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. \>90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle

Conditions

Physical Activity

Keywords

Bicycling

Outcome Measures

Primary Outcomes (1)

• Post-Intervention Bicycling to School

  Mode of transport to school

  During weeks 3-5 of the intervention

Secondary Outcomes (3)

• Pre-Intervention Moderate-to-vigorous physical activity (MVPA)

  Baseline

• Post-Intervention Moderate-to-vigorous physical activity (MVPA)

  During weeks 3-5 of the intervention

• Pre-Intervention Bicycling to School

  Baseline

Study Arms (2)

Bicycle Train Intervention

EXPERIMENTAL

The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course.

Behavioral: Bicycle Train

Control

NO INTERVENTION

The control arm does not receive any intervention. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course.

Interventions

Bicycle Train BEHAVIORAL

The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants

Bicycle Train Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• attends a study school and is in the 4th or 5th grade,
• physically capable of riding a bicycle to and from school
• lives within approximately 2-miles of a study school
• has room at home to safely store a bicycle.

You may not qualify if:

• not in the 4th or 5th grade at a study school
• incapable of riding a bicycle to and from school
• lives beyond approximately 2-miles of a study school
• does not have room at home to safely store a bicycle

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145-5005, United States

Location

Related Publications (1)

• Mendoza JA, Haaland W, Jacobs M, Abbey-Lambertz M, Miller J, Salls D, Todd W, Madding R, Ellis K, Kerr J. Bicycle Trains, Cycling, and Physical Activity: A Pilot Cluster RCT. Am J Prev Med. 2017 Oct;53(4):481-489. doi: 10.1016/j.amepre.2017.05.001. Epub 2017 Jun 28.

  PMID: 28668251 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jason A Mendoza, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

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: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1)