Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Study on Bicycle Trains to Improve Children's Physical Activity
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


Options:
A: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
B: Inclusion Criteria:

* Being student in the included public high school in Region of Lorraine (East of France) whatever the age

Exclusion Criteria:

* None
C: Inclusion Criteria:

* Healthy pupils of primary schools (5th grade) and secondary schools (10th grade)
D: Inclusion Criteria:

* The schools must be located within the municipality of Madrid
* The schools must be public
* The schools must have, at the least, two classes for Preschool Education, for children 3, 4 and 5 years of age
* The schools must make available the use of the cafeteria.

Exclusion Criteria:

* NA

Answer: A