## Protocol Section
### Identification Module
**NCT ID:** NCT03087279

**Acronym:** ICAN

**Brief Title:** Assessing Impact of Active Learning on Student Outcomes: Texas Initiatives for Children's Activity and Nutrition (ICAN)

**Official Title:** 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

#### Organization Study ID Info
**ID:** 1R01HD070741
**Link:** https://reporter.nih.gov/quickSearch/1R01HD070741
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Texas at Austin
### Status Module
#### Completion Date
**Date:** 2015-05-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-06-26

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-05-31

**Type:** ACTUAL

#### Start Date
**Date:** 2012-08-15

**Type:** ACTUAL

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2017-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-09
**Study First Submit QC Date:** 2017-03-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas at Austin

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Physical Activity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 2716

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Texas I-CAN Active math lesson in academic classroom

**Intervention Names:**

- Behavioral: Texas I-CAN!

**Label:** Texas I-CAN Active Math Lessons

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Texas I-CAN Active language arts lessons in academic classroom

**Intervention Names:**

- Behavioral: Texas I-CAN!

**Label:** Texas I-CAN Active Language Arts Lessons

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Regular, Sedentary academic lessons in math and language arts

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Texas I-CAN Active Language Arts Lessons

- Texas I-CAN Active Math Lessons

**Description:** physically active, academic lessons in the elementary school classroom

**Name:** Texas I-CAN!

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** time in moderate to vigorous physical activity

**Measure:** Physical activity level

**Time Frame:** one school week

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

**Measure:** Time on task

**Time Frame:** change in time on task from baseline to 15 minutes post academic lesson

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

**Measure:** Acute academic achievement

**Time Frame:** change in math and language arts scores from Baseline to 2 weeks

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

**Measure:** Long-term math achievement

**Time Frame:** Change in math achievement scores from Baseline to 7 months

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

**Measure:** Long-term language arts achievement

**Time Frame:** Change in language arts achievement from Baseline to 7 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* none

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** UT Austin

**Name:** John B Bartholomew, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 28739542

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
