Physical Activity Clinical Trial
Official title:
Pilot Study on Bicycle Trains to Improve Children's Physical Activity
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
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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