NCT03493139

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 21, 2024

Status Verified

September 1, 2020

Enrollment Period

6.3 years

First QC Date

April 3, 2018

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • MVPA time during the school day

    Year 3

  • Total daily MVPA

    Year 3

  • Body mass index (BMI)

    Fall Semester Year 1

  • Body mass index (BMI)

    Spring Semester Year 1

  • Body mass index (BMI)

    Spring Semester Year 2

  • +2 more secondary outcomes

Study Arms (2)

PAAC-R

EXPERIMENTAL

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

PAAC-T

EXPERIMENTAL

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

Interventions

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.

PAAC-RPAAC-T

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • nd and 3rd grade students

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 32006633BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Joseph Donnelly, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Classroom Physical Activity Breaks Delivered by Teacher vs. Classroom Physical Activity Breaks Delivered by Video
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 10, 2018

Study Start

March 1, 2018

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

August 21, 2024

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Please contact PI.

Shared Documents
STUDY PROTOCOL
Time Frame
After 1/2026

Locations