NCT02810834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

May 11, 2015

Last Update Submit

August 31, 2017

Conditions

Physical Activity

Keywords

Executive FunctionAcademic Performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cognitive performance

    5 months and 1.5 years

  • Academic achievement

    5 months and 1.5 years

Study Arms (3)

Walking/Running Program

EXPERIMENTAL

Walking/running/jogging program; school-based.

Behavioral: Walking/Running program

Classroom activity break program

EXPERIMENTAL

Classroom physical activity break program; school-based.

Behavioral: Classroom physical activity break program

Control

NO INTERVENTION

Control/Delayed Intervention

Interventions

Walking/Running programBEHAVIORAL

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)

Also known as: 100 Mile Club
Walking/Running Program
Classroom physical activity break programBEHAVIORAL

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)

Also known as: Just Move
Classroom activity break program

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Not a 3rd or 4th grade student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (5)

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PMID: 34555181DERIVED

  • Sacheck JM, Wright CM, Amin SA, Anzman-Frasca S, Chomitz VM, Chui KK, Duquesnay PJ, Nelson ME, Economos CD. The Fueling Learning Through Exercise Study Cluster RCT: Impact on Children's Moderate-to-Vigorous Physical Activity. Am J Prev Med. 2021 Jun;60(6):e239-e249. doi: 10.1016/j.amepre.2021.01.002. Epub 2021 Mar 26.

    PMID: 33781620DERIVED

  • Wright CM, Chomitz VR, Duquesnay PJ, Amin SA, Economos CD, Sacheck JM. The FLEX study school-based physical activity programs - measurement and evaluation of implementation. BMC Public Health. 2019 Jan 16;19(1):73. doi: 10.1186/s12889-018-6335-3.

    PMID: 30651117DERIVED

  • Amin SA, Duquesnay PJ, Wright CM, Chui K, Economos CD, Sacheck JM. The Association Between Perceived Athletic Competence and Physical Activity: Implications for Low-Income Schoolchildren. Pediatr Exerc Sci. 2018 Aug 1;30(3):433-440. doi: 10.1123/pes.2017-0242. Epub 2018 Mar 15.

    PMID: 29543115DERIVED

  • Wright CM, Duquesnay PJ, Anzman-Frasca S, Chomitz VR, Chui K, Economos CD, Langevin EG, Nelson ME, Sacheck JM. Study protocol: the Fueling Learning through Exercise (FLEX) study - a randomized controlled trial of the impact of school-based physical activity programs on children's physical activity, cognitive function, and academic achievement. BMC Public Health. 2016 Oct 13;16(1):1078. doi: 10.1186/s12889-016-3719-0.

    PMID: 27737676DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Jennifer M Sacheck, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

June 23, 2016

Study Start

September 1, 2014

Primary Completion

June 23, 2017

Study Completion

July 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

US(1)