Understanding the Impact of School-Based Physical Activity Programs

Study Overview
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Brief Summary
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The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.

Detailed Description
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The FLEX Study is a three-year, randomized control trial that seeks to understand how two different innovative school-based physical activity (PA) programs influence not only children's time spent in MVPA but also their cognitive and academic outcomes. The FLEX Study will be implemented and evaluated by researchers from Tufts University. The project is funded by the National Institutes of Health. Schools participating in the study will be randomly assigned to receive a walking/running program, a classroom physical activity program, or no program (control) during first year and a half of the study. Third and fourth grade children will be enrolled in the study. Physical activity will be assessed objectively using accelerometry. Additional measurements will include: BMI/BMI-z (measured height and weight), diet and physical activity questionnaires, cognitive functioning (tests of working memory and inhibitory control).

Official Title
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Understanding the Impact of School-Based Physical Activity Programs

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Walking/Running program
* Behavioral: Classroom physical activity break program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children participants 3rd or 4th grade student in participating school (during first school year of study) Exclusion Criteria: Not a 3rd or 4th grade student

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking/Running Program<br>Walking/running/jogging program; school-based. | Behavioral: Walking/Running program<br>* Participants will receive a behavioral intervention that consists of a school-based, walking/running/jogging program. Participants work to accumulate miles towards a goal of at least 100 miles, over the course of the school year. Program will be implemented through a champion in the school and structured/scheduled according to the schools resources (before, during, or after school). Miles are tracked at the school level, and incentives are provided for participants' completion of set milestones (25, 50, 75, and 100 miles). The intervention will run over two school years (approximately 16 months)<br>* Other names: 100 Mile Club;|
| Experimental: Classroom activity break program<br>Classroom physical activity break program; school-based. | Behavioral: Classroom physical activity break program<br>* Participants will receive a behavioral intervention that consists of a classroom-based, physical activity break program. Classroom teachers, paraprofessionals, and other school staff will lead short (5-15 minute) activity breaks that include both higher intensity (ex. jumping jacks, squats) and low-intensity (ex. stretching, yoga) activities. Classrooms will be encouraged to integrate at least one short break per day. Activities are connected to national Common Core academic standards so that breaks can be integrated with academics. The intervention will run over two school years (approximately 16 months)<br>* Other names: Just Move;|
| No Intervention: Control<br>Control/Delayed Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School-time and total daily MVPA | Changes in minutes of school-time and total daily moderate-to-vigorous physical activity (MVPA) among third-fifth graders participating in innovative school-based physical activity programs, compared to controls | 5 months and 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | Changes in cognitive performance, as measured by standard tests of executive function, among third-fifth graders participating in innovative | 5 months and 1.5 years | 
| Academic achievement | Changes in academic achievement, as measured by standardized tests (English language art and math), among third-fifth graders participating in innovative | 5 months and 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive Function, Academic Performance