A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes

July 10, 2020 updated by: Julie A Gazmararian, Emory University

A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes in Georgia's Elementary Schools (RWJF)

The study is a prospective study to examine the impact of a school-based physical activity intervention on fourth and fifth grade elementary students' academic achievement, as measured by standardized test scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Serving more than 95% of US children ages 5-17, the school environment is a valuable setting to engage students in Physical Activity (PA) through the day, but is limited when physical education programs have insufficient curricular, time, financial and staffing allocations. A growing body of research supports the premise that interventions focused on increasing physical activity in schools may be more successful if supported by evidence that increased PA improves academic achievement, that is the clear priority for limited school time and resources.

The purpose of this study is to examine the impact of a school-based physical activity intervention on fourth and fifth grade elementary students' academic achievement, as measured by standardized test scores. Baseline information about current physical activity practices will be collected. Schools will receive ongoing in-person and virtual training, and schools will be provided physical activity equipment, resources, and teaching aids. Student accelerometer data will allow for monitoring of physical activity levels. This study seeks to address gaps in the literature by studying the efficacy of a well-established intervention that has been shown to impact school physical activities practices, and shows promise of efficacy for improving student education outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4968

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Lawrenceville, Georgia, United States, 30044
        • Gwinnett County Elementary Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4th grade students from the elementary schools in the Gwinnett County district

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm

This study arm includes the schools where the School Team (school teachers, coordinator) receives the physical activity intervention. The intervention consists of four parts:

  1. School Engagement and Assessment
  2. Training
  3. Physical Activity Equipment and Resources
  4. Ongoing Assessment and Technical Assistance
Behavioral: Intervention Arm

The physical activity intervention consists of:

  1. School Engagement and Assessment - Based on the customized assessment, training is provided for school staff to develop the capacity to increase PA. A school PA team is established.
  2. Training - School teams are provided with ongoing in-person and virtual training to learn strategies for increasing PA before and during the school day. A training summit meeting will occur each summer, starting with the summer prior to the intervention. Teams will create a weekly calendar of activities to increase PA time to a minimum of 40 mts/day.
  3. PA Equipment and Resources - After training, schools are provided with PA equipment, resources and teaching aids to facilitate the integration of PA into the school day.
  4. Ongoing Assessment and Technical Assistance - Student accelerometer data will allow for monitoring of PA levels, so that additional technical assistance for classroom teachers can be provided if needed
No Intervention: Control Arm
The control arm includes the schools where the School Team does not receive any intervention but all the necessary data will be collected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Georgia Milestones standardized test scores in math
Time Frame: Up to 2 years
The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies. The tests are scored with four achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels of math are 290-474, 475-524, 525-579, and 580-705; for grade 4, 270-474, 475-524, 525-584, and 580-715; for grade 5, 265-474, 475-524, 525-579, and 580-725, respectively. The scores from the 3rd grade (pre-intervention) are compared to scores at the end of 4th and 5th grades.
Up to 2 years
Change in the Georgia Milestones standardized test scores in reading
Time Frame: Up to 2 years
The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies.The tests are scored with 4 achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels for reading are 180-474, 475-524, 525-580, and 581-830; for grade 4, 210-474, 475-524, 525-573, and 574-775; for grade 5, 210-474, 475-524, 525-586, and 587-760, respectively. The scores from the 3rd grade assessment (pre-intervention) are compared to scores at the end of 4th and 5th grades.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Lexile/reading level for language arts
Time Frame: Up to 2 years
Lexile Level is a popular method used by schools to measure a student reader's ability. It serves two unique functions: it is a measure of how difficult a text is, and a measurement of a student's reading ability level. A student receives his or her Lexile measure by taking a school-administered Scholastic Reading Inventory test, which is specifically designed to measure Lexile or reading ability, or by taking a standardized reading test which converts the reader's results to a Lexile measure. The normal Scholastic Guided Reading Lexile ranges for 3rd grade are 100-1120, 180-1280 for 4th grade, and 330-1280 for 5th grade.
Up to 2 years
Change in the class grades for reading
Time Frame: Up to 2 years
Class grades are calculated from the reading tests administered during the school year. The class grades for reading from 3rd grade are compared to 4th and 5th grades, and class reading grades are also compared between the students in the intervention arm and control arm.
Up to 2 years
Change in the class grades for math
Time Frame: Up to 2 years
Class grades are calculated from the math tests administered during the school year. The class math grades from 3rd grade are compared to 4th and 5th grades, and math grades are also compared between the students in the intervention arm and control arm.
Up to 2 years
Number of Disciplinary Referrals
Time Frame: Up to 2 years
Disciplinary referrals collected by teachers (including information regarding incident date, incident type, action taken, rule number broken, and discipline code) will be compared between grade levels and also compared between the students in the intervention arm and control arm.
Up to 2 years
Number of days of absence
Time Frame: Up to 2 years
The number of days that students were absent from school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.
Up to 2 years
Number of days a student was tardy to the school
Time Frame: Up to 2 years
The number of days that students were tardy to school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Robert Wood Johnson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julie Gazmararian, PhD/MPH, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00095600
  • 74281 (Other Grant/Funding Number: Robert Wood Johnson Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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