NCT03256188

Brief Summary

This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute activity breaks in elementary school classrooms. Three elementary schools in Southeast Michigan (20 teachers, 500 students) participated in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

August 15, 2017

Last Update Submit

August 16, 2017

Conditions

Physical Activity

Keywords

classroomprolonged sittingsedentary timetime-on-taskchildren

Outcome Measures

Primary Outcomes (2)

  • Moderate-to-vigorous physical activity (student)

    Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess student physical activity intensity and physical activity minutes completed in the classroom.

    16 weeks

  • Moderate-to-vigorous physical activity (teacher)

    Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess teacher physical activity intensity and physical activity minutes completed in the classroom.

    16 weeks

Secondary Outcomes (5)

  • Transition time

    16 weeks

  • Time-on-task

    16 weeks

  • Physical activity enjoyment

    16 weeks

  • Physical activity confidence

    16 weeks

  • Physical activity heart rate

    16 weeks

Study Arms (1)

Active classroom

EXPERIMENTAL

Twenty elementary school teachers implemented 10, 3-minute moderate-to-vigorous physical activity breaks (50-75% of heart rate maximum), 5 days per week in their classrooms over a 16-week period.

Behavioral: Active classroom

Interventions

Active classroomBEHAVIORAL

30 minutes of moderate-to-vigorous physical activity

Also known as: InPACT classroom
Active classroom

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • rd thru 6th grade students in participating InPACT classrooms

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childhood Disparities Research Laboratory

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rebecca E Hasson, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 21, 2017

Study Start

August 15, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)