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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01699295
Other study ID # 13460
Secondary ID
Status Completed
Phase N/A
First received October 1, 2012
Last updated January 9, 2016
Start date September 2011
Est. completion date June 2015

Study information

Verified date January 2016
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Recruitment information / eligibility

Status Completed
Enrollment 584
Est. completion date June 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria:

- Grade 2 or 3 Student at one of the randomly selected elementary schools

- Students that agree to complete assessments

- Signed parental consent form

- Signed child assent form

Exclusion Criteria:

- Students that do not agree to complete assessments

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
A+PAAC
academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.
CON
lessons taught by regular classroom teachers using traditional/regular sedentary lessons

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
Joseph Donnelly

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Academic Achievement in Elementary Students Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON) Baseline to 3 Years No
Secondary Assessment of Cognitive Function Changes in attentional control and academic achievement Baseline to 3 Years No
Secondary Body Mass Index (BMI) Change in the BMI over course of the study. Baseline to 3 Years No
Secondary Cardiovascular (CV) Fitness and Daily Physical Activity (PA) Changes in CV Fitness and PA and its impact on cognitive control of attention and academic achievement Baseline to 3 Years No
Secondary Change in Attention-to-Task Baseline to 3 Years No
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