Understanding the Impact of School-Based Physical Activity Programs

Physical Activity Clinical Trial

Official title:

Understanding the Impact of School-Based Physical Activity Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810834
• Other study ID #: R01HD080180
• Secondary ID: 1R01HD080180-01A
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: August 31, 2017
• Start date: September 2014
• Est. completion date: July 1, 2017

Study information

• Verified date: August 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1182
• Est. completion date: July 1, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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