Physical ActivityICANNCT03087279
Assessing Impact of Active Learning on Student Outcomes: Texas Initiatives for Children's Activity and Nutrition (ICAN)
A study testing Texas I-CAN! in people with Physical Activity, run by University of Texas at Austin.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Texas I-CAN!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,716 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2012to 31 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- students in 4th grade in a participating elementary school and their 4th grade teachers
Who cannot join
- none
About this study
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
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
- Physical Activity
- Being tested
- Texas I-CAN!
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texas I-CAN!Behavioural
physically active, academic lessons in the elementary school classroom
| Study group | Role | What they receive |
|---|---|---|
| Texas I-CAN Active Math Lessons | Experimental | Texas I-CAN Active math lesson in academic classroom Receives: Behavioral: Texas I-CAN! |
| Texas I-CAN Active Language Arts Lessons | Experimental | Texas I-CAN Active language arts lessons in academic classroom Receives: Behavioral: Texas I-CAN! |
| Control | No intervention | Regular, Sedentary academic lessons in math and language arts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
time in moderate to vigorous physical activity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change in language arts achievement from Baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start15 Aug 2012
- Primary completion31 May 2015
- Study completion31 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,716 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John B Bartholomew, PHD, Principal investigator, UT Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087279
- Sponsor's protocol ID
- 1R01HD070741
- Acronym
- ICAN
- Status last verified
- Jun 2017
- First submitted
- 9 Mar 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28739542
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03087279
- Acronym / sponsor ID
- ICAN / 1R01HD070741
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,716 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Aug 2012 (actual)
- Primary completion
- 31 May 2015 (actual)
- Study completion
- 31 May 2015 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Texas I-CAN Active Math Lessons | Experimental | Behavioral: Texas I-CAN!Texas I-CAN Active math lesson in academic classroom |
| Texas I-CAN Active Language Arts Lessons | Experimental | Behavioral: Texas I-CAN!Texas I-CAN Active language arts lessons in academic classroom |
| Control | No intervention | –Regular, Sedentary academic lessons in math and language arts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- students in 4th grade in a participating elementary school and their 4th grade teachers
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Texas I-CAN!physically active, academic lessons in the elementary school classroom | Behavioural | Texas I-CAN Active Language Arts Lessons, Texas I-CAN Active Math Lessons |
Primary outcome
Physical activity level
Time frame: one school week
time in moderate to vigorous physical activity
Time on task
Time frame: change in time on task from baseline to 15 minutes post academic lesson
student attentional focus in the classroom 15 minutes prior to and 15 minutes post active lesson implemented in the classroom on one school day
Acute academic achievement
Time frame: change in math and language arts scores from Baseline to 2 weeks
acute academic scores on math and language arts test developed by fourth grade teacher
Long-term math achievement
Time frame: Change in math achievement scores from Baseline to 7 months
Academic scores on math sub tests (Calculation, Fluency) of the Woodcock Johnson III
Long-term language arts achievement
Time frame: Change in language arts achievement from Baseline to 7 months
Academic scores on spelling sub test of the Woodcock Johnson III and comprehension section of Gates MacGinitie test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Derived from this study: PubMed 28739542Bartholomew 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B Bartholomew, PHD principal investigator
UT Austin
Questions about this trial
What is this clinical trial studying?
A study testing Texas I-CAN! in people with Physical Activity, run by University of Texas at Austin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: one school week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.