Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity Breaks

The study is designed to compare two methods of delivering short (~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Physical Activity Across the Curriculum

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Donnelly, PhD; Phone Number: (785) 864-1687; Email: jdonnelly2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2nd and 3rd grade students

Exclusion Criteria:

• Students who are confined to a wheel chair, blind, or intellectually disadvantaged may be unable perform tests for cardiovascular fitness or MVPA using accelerometers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAAC-R; Physical Activity Across the Curriculum-Remote (PAAC-R) will include protocol specific activity breaks delivered remotely via a television in the classroom.	Behavioral: Physical Activity Across the Curriculum; Activity breaks will be designed for delivery in the classroom without reconfiguration of the classroom space. Activities will emphasize whole body movements, using large muscle groups. Each break includes multiple activities. Each activity lasts about 2 minutes. There will be a total of about 20 minutes of physical activity done each school day.
Experimental: PAAC-T; Physical Activity Across the Curriculum-Teacher (PAAC-T) will include protocol specific activity breaks delivered by the classroom teacher.	Behavioral: Physical Activity Across the Curriculum; Activity breaks will be designed for delivery in the classroom without reconfiguration of the classroom space. Activities will emphasize whole body movements, using large muscle groups. Each break includes multiple activities. Each activity lasts about 2 minutes. There will be a total of about 20 minutes of physical activity done each school day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate-to-vigorous physical activity (MVPA) time during activity breaks	Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the period of activity breaks. Measure will be captured using an accelerometer.	Year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MVPA time during the school day	Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the school day. Measure will be captured using an accelerometer.	Year 3
Total daily MVPA	Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the entire day. Measure will be captured using an accelerometer.	Year 3
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Fall Semester Year 1
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Spring Semester Year 1
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Spring Semester Year 2
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Spring Semester Year 3
Energy expenditure of activity breaks	Calculated as the number of calories used during a classroom activity break.	Year 2

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Joseph Donnelly, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Szabo-Reed AN, Washburn RA, Greene JL, Ptomey LT, Gorczyca A, Lee RH, Little TD, Lee J, Honas J, Donnelly JE. Physical activity across the curriculum (PAAC3): Testing the application of technology delivered classroom physical activity breaks. Contemp Clin Trials. 2020 Mar;90:105952. doi: 10.1016/j.cct.2020.105952. Epub 2020 Jan 29.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00141841; R01DK085317 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No