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Understanding the Impact of School-Based Physical Activity Programs

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ClinicalTrials.gov Identifier: NCT02810834
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Walking/Running program Behavioral: Classroom physical activity break program Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Understanding the Impact of School-Based Physical Activity Programs
Study Start Date : September 2014
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking/Running Program
Walking/running/jogging program; school-based.
Behavioral: Walking/Running program

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 Name: 100 Mile Club

Experimental: Classroom activity break program
Classroom physical activity break program; school-based.
Behavioral: Classroom physical activity break program

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 Name: Just Move

No Intervention: Control
Control/Delayed Intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810834


Locations
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United States, Massachusetts
Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Investigators
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Principal Investigator: Jennifer M Sacheck, PhD Tufts University