Understanding the Impact of School-Based Physical Activity Programs

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: Walking/Running program; Behavioral: Classroom physical activity break program

• Registration Number: NCT02810834
• Lead Sponsor: Tufts University

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Primary Completion: 2017-06-23
• Study Completion: 2017-07-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1182

Inclusion Criteria

Children participants 3rd or 4th grade student in participating school (during first school year of study)

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Exclusion Criteria

Not a 3rd or 4th grade student

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking/Running Program	Walking/Running program	Walking/running/jogging program; school-based.
Classroom activity break program	Classroom physical activity break program	Classroom physical activity break program; school-based.

Primary Outcome Measures

Name	Time	Method
School-time and total daily MVPA	5 months and 1.5 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University; 🇺🇸 Boston, Massachusetts, United States