Physical ActivityNCT03765047
A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes
A study testing Intervention Arm in people with Physical Activity, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Activity
- What is being tested?
- Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,968 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 19 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 4th grade students from the elementary schools in the Gwinnett County district
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Gwinnett County Elementary Schools
Lawrenceville, Georgia, 30044
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Intervention Arm
- Keywords
- Standardized Test Score, Academic Achievement
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmBehavioural
The physical activity intervention consists of:
- 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.
- 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.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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 Receives: Behavioral: Intervention Arm |
| Control Arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in the Georgia Milestones standardized test scores in math
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.
Measured: Up to 2 years
Change in the Georgia Milestones standardized test scores in reading
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.
Measured: Up to 2 years
Secondary outcomes (6)
Change in the Lexile/reading level for language arts
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.
Measured: Up to 2 years
Change in the class grades for reading
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.
Measured: Up to 2 years
Change in the class grades for math
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.
Measured: Up to 2 years
Number of Disciplinary Referrals
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.
Measured: Up to 2 years
Number of days of absence
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.
Measured: Up to 2 years
Number of days a student was tardy to the school
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start6 Aug 2018
- Primary completion19 Jun 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Julie A Gazmararian, Emory University
- Investigators
- Julie Gazmararian, PhD/MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765047
- Sponsor's protocol ID
- IRB00095600
- Other IDs
- 74281
- Status last verified
- Jul 2020
- First submitted
- 3 Dec 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Behringer HK, Saksvig ER, Boedeker PJ, Elish PN, Kay CM, Calvert HG, Meyer AM, Gazmararian JA. Physical activity and academic achievement: an analysis of potential student- and school-level moderators. Int J Behav Nutr Phys Act. 2022 Aug 30;19(1):110. doi: 10.1186/s12966-022-01348-3.
PubMed 36042515Elish PN, Bryan CS, Boedeker PJ, Calvert HG, Kay CM, Meyer AM, Gazmararian JA. The longitudinal association between objectively-measured school-day physical activity and academic achievement in US elementary school students. Int J Behav Nutr Phys Act. 2022 Jul 23;19(1):90. doi: 10.1186/s12966-022-01328-7.
PubMed 35870926
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes in Georgia's Elementary Schools (RWJF)
- ClinicalTrials.gov ID
- NCT03765047
- Acronym / sponsor ID
- IRB00095600
- Conditions
- Physical Activity
- Keywords
- Standardized Test Score, Academic Achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,968 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Intervention ArmThis 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 |
| Control Arm | No intervention | –The control arm includes the schools where the School Team does not receive any intervention but all the necessary data will be collected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 4th grade students from the elementary schools in the Gwinnett County district
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ArmThe 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 | Behavioural | Intervention Arm |
Primary outcome
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.
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.
6 secondary outcomes
Change in the Lexile/reading level for language arts
Time frame: Up to 2 years
Change in the class grades for reading
Time frame: Up to 2 years
Change in the class grades for math
Time frame: Up to 2 years
Number of Disciplinary Referrals
Time frame: Up to 2 years
Number of days of absence
Time frame: Up to 2 years
Number of days a student was tardy to the school
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 36042515Behringer HK, Saksvig ER, Boedeker PJ, Elish PN, Kay CM, Calvert HG, Meyer AM, Gazmararian JA. Physical activity and academic achievement: an analysis of potential student- and school-level moderators. Int J Behav Nutr Phys Act. 2022 Aug 30;19(1):110. doi: 10.1186/s12966-022-01348-3.
- Derived from this study: PubMed 35870926Elish PN, Bryan CS, Boedeker PJ, Calvert HG, Kay CM, Meyer AM, Gazmararian JA. The longitudinal association between objectively-measured school-day physical activity and academic achievement in US elementary school students. Int J Behav Nutr Phys Act. 2022 Jul 23;19(1):90. doi: 10.1186/s12966-022-01328-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Gazmararian, PhD/MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with Physical Activity, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Georgia Milestones standardized test scores in math (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.