Pilot and Feasibility Bicycle Train Study
Condition: Physical Activity
Study type: Interventional

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
    

Detailed description: 
      Physical activity decreases the risk of cardiovascular disease, Type 2 Diabetes, and multiple
      cancers, and is important for obesity prevention. 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 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. This pilot
      study will provide feasibility data and extend the validity of quantifying cycling-related
      MVPA for a future fully-powered R01-funded Bicycle Train cluster RCT.

      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

      This R21 application will provide important planning and methods validation targeted towards
      ethnic-minority children, the population at highest risk for childhood obesity in the US.
    

Intervention name(s): Bicycle Train
Intervention type(s): Behavioral
Intervention description(s): The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bicycling