NCT03087279

Brief Summary

Background: Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. Discussion: This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,716

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

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

August 15, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

March 9, 2017

Last Update Submit

June 22, 2017

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (5)

  • Physical activity level

    time in moderate to vigorous physical activity

    one school week

  • Time on task

    student attentional focus in the classroom 15 minutes prior to and 15 minutes post active lesson implemented in the classroom on one school day

    change in time on task from baseline to 15 minutes post academic lesson

  • Acute academic achievement

    acute academic scores on math and language arts test developed by fourth grade teacher

    change in math and language arts scores from Baseline to 2 weeks

  • Long-term math achievement

    Academic scores on math sub tests (Calculation, Fluency) of the Woodcock Johnson III

    Change in math achievement scores from Baseline to 7 months

  • Long-term language arts achievement

    Academic scores on spelling sub test of the Woodcock Johnson III and comprehension section of Gates MacGinitie test

    Change in language arts achievement from Baseline to 7 months

Study Arms (3)

Texas I-CAN Active Math Lessons

EXPERIMENTAL

Texas I-CAN Active math lesson in academic classroom

Behavioral: Texas I-CAN!

Texas I-CAN Active Language Arts Lessons

EXPERIMENTAL

Texas I-CAN Active language arts lessons in academic classroom

Behavioral: Texas I-CAN!

Control

NO INTERVENTION

Regular, Sedentary academic lessons in math and language arts

Interventions

Texas I-CAN!BEHAVIORAL

physically active, academic lessons in the elementary school classroom

Texas I-CAN Active Language Arts LessonsTexas I-CAN Active Math Lessons

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • students in 4th grade in a participating elementary school and their 4th grade teachers

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bartholomew JB, Jowers EM, Errisuriz VL, Vaughn S, Roberts G. A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial. Contemp Clin Trials. 2017 Oct;61:81-86. doi: 10.1016/j.cct.2017.07.023. Epub 2017 Jul 22.

    PMID: 28739542DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John B Bartholomew, PHD

    UT Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 22, 2017

Study Start

August 15, 2012

Primary Completion

May 31, 2015

Study Completion

May 31, 2015

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share