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Completed

NCT Number: NCT02810834

Understanding the Impact of School-Based Physical Activity Programs

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University

Boston, Massachusetts, 02111, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking/Running program

Behavioral

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)

Other names: 100 Mile Club

Classroom physical activity break program

Behavioral

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)

Other names: Just Move

Primary outcomes

  1. School-time and total daily MVPA

    Time frame: 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 outcomes

  1. Cognitive performance

    Time frame: 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

  2. Academic achievement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of California, San Diego

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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