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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03765047
Other study ID # IRB00095600
Secondary ID 74281
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2018
Est. completion date June 19, 2020

Study information

Verified date July 2020
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4968
Est. completion date June 19, 2020
Est. primary completion date June 19, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention Arm
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

Locations

Country Name City State
United States Gwinnett County Elementary Schools Lawrenceville Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 2 years
Primary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary 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. Up to 2 years
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