ClinicalTrials.gg
CompletedNCT03394846Updated Jan 24, 2025Results posted

Classroom Activities

An Early Phase 1 interventional study of Test of Existing MI Products in Physical Activity, sponsored by University of South Carolina. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by University of South Carolina · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Motor Activity by University of South Carolina — 10 open to participants now, 12 under way, none of them phase 3. Motor Activity · University of South Carolina.

Enrollment
24th of 35
57 · median 150
Started
2018
with 2 others
Phase 1
3 of 38
none open now
Registered
13th of 38
by date

Among the 38 studies in Motor Activity by University of South Carolina, this one is the 24th largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2018, is one of 3 in phase 1, and was the 13th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

10 of the 38 studies in Motor Activity by University of South Carolina are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies in Motor Activity by University of South Carolina, or all of them as a file.
02

Study summary

Movement integration programs that incorporate physical activity into academics are widely available for teachers to use, and have been shown to provide meaningful amounts of physical activity, improve on-task behavior, enhance cognitive function, and increase standardized test scores of children. However, teachers rarely use these programs. This project aims to use product testing and development methodologies to test current movement integration programs, identify critical attributes of those programs that hinder or enhance uptake by teachers, and develop a novel movement integration program based on those attributes.

Read the detailed description

Movement integration (MI) is a strategy for integrating physical activity into general education classroom time. National organizations have identified MI as a key strategy for helping children accumulate the recommended 60 minutes of moderate-to-vigorous physical activity per day. Research has consistently demonstrated that MI can provide meaningful amounts of physical activity, improve on-task behavior, enhance cognitive function, and increase standardized test scores.This strategy is also increasingly important because children spend less and less time in active school settings, such as recess and physical education. However, teachers rarely incorporate MI into their classrooms.

In order to encourage teachers to use MI more regularly, it is essential to understand which MI product attributes lead to greater use. While some work has been done to identify which attributes of MI products enhance teacher use, this work has either examined the use of MI as a general concept (i.e., what would make teachers more likely to infuse physical activity [PA] into their classroom routines); or was conducted within the context of a single MI product (i.e., what makes teachers more likely to implement a specific MI product, such as Take 10).These approaches have two major limitations. First, studies that examined MI as a general concept (i.e., what would make teachers more likely to infuse physical activity into their classroom routines) are limited because teachers were not able to test MI products. Second, because previous studies solicited feedback on a single MI product, even though several MI products with varying attributes are available, teachers' ability to identify desirable MI product attributes across MI products was limited.

Currently, six MI products are widely available to teachers. These products differ significantly in their degree of (a) academic focus, (b) level of teacher involvement, and (c) time commitment for planning and implementation. For example, Go Noodle is a website that contains short (3-5 minute) videos of mostly non-academic MI activities. Teachers can simply select a video to play. Conversely, the Take 10 product consists of activity cards that present physical activities infused with academic content, plus instructions for how teachers can organize and implement the activities. These two products represent opposite ends of the MI product spectrum, but no one MI product includes all of the key attributes that may encourage use. Understanding the attributes that teachers want in MI products would allow researchers and educators to design products that have greater appeal and are more likely to be used (i.e., increased implementation).

Product testing is one way to identify attributes that enhance or hinder uptake by teachers. Product testing is the process of measuring the properties or performance of products. Two of the most common product testing techniques are in-home use tests, and discrete choice experiments (DCE). In-home use tests allow potential consumers (in this case teachers) to use a product as they normally would in their natural setting. DCEs involve asking individuals to identify their preferences when given a hypothetical set of attributes products could contain.Product testing is essential when developing new products, because it can help to produce superior products, by identifying critical attributes that consumers desire. Research has categorically shown that including consumers in the development of new products is critical to the success of the products. However, the process of developing previous MI products has not included this step.

This study will expand the evidence related to implementation of MI by classroom teachers by identifying product attributes that will lead to increased use of MI products by teachers. To do this we will draw upon product testing research techniques to test widely-available MI products and to identify attributes of MI products that make them more or less usable. We will accomplish the following specific aims:

Aim 1: Identify the key attributes of Movement Integration products that teachers prefer and do not prefer, using a DCE and in-class product testing.

Aim 2: Develop a prototype Movement Integration product that incorporates the critical attributes identified by teachers in Aim 1.

Aim 3: Conduct a pilot test of the prototype Movement Integration product developed in Aim 2 to evaluate teacher implementation, the product's effect on children's activity levels during classroom time, and cost.

This project is significant because MI can reach virtually all children each day at school. The project is innovative because it will produce a MI product prototype using product testing techniques with classroom teachers. The expected project outcome is a MI product prototype with the potential to be more widely implemented throughout the country.

Updates Due to Covid-19: Because of the closure of schools due to the novel SARS-CoV-2 (COVID-19) pandemic and due to the pilot data collected in Aim 1 the design of this study has undergone changes. Upon the completion of Aim 1 it became clear that existing MI products contained all of the key attributes that teachers desired. Thus, the decision was made not to create a novel MI product but rather to test the impact of the three products that teachers ranked the highest in Aim 1 on students' physical activity. Teachers began testing products in January of 2020 and all of the participating schools closed their doors in March of 2020 due to COVID-19. Prior to the closure teachers were able to complete a baseline week and test one product. These schools reopened in the fall of 2021 but have not allowed external visitors to the school, including study research teams. Thus it has been and remains impossible to complete the study as intended. Given that the grant funding for this project has come to a close it is the investigators' intention to publish the findings as is, while recognizing and transparently reporting their limitations.

03

Conditions studied

  • Physical Activity

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04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  • Participants must be an elementary classroom teacher.
  • Must be employed full time by their school district
  • Must be the primary classroom teacher with a class of 15 or more students of elementary age
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Test of Existing MI Products

    We will test the impact of three widely available MI products (GoNoodle, Take10, ABC for Fitness) on students' physical activity with 60 elementary classroom teachers.

    Behavioral: Test of Existing MI Products

Interventions

  • BehavioralTest of Existing MI Products

    Three widely available MI products (GoNoodle, Take10, ABC for Fitness) will be tested by teachers in their classrooms. Teachers will participate in the study for four weeks (one baseline week, one week for each product).

06

What researchers measure

Primary outcomes

  1. Change in Use of Movement Integration Strategies (Mean Per Day)

    Change in self-reported use of movement integration strategies per day. Teachers will complete a weekly log of movement integration product implementation. To complete the log, each teacher will log onto a password-protected website. Teachers will indicate the number of MI product uses per day. If teachers fail to complete the log they will receive an email reminder.

    Time frame: 5 school days (Data was averaged across the 5 days) at baseline (teachers did not have the movement integration product) and outcome (one week following baseline when teachers were provided the movement integration product)

07

Results

Posted Jan 24, 2025

Participant flow

Participant flow — Overall Study
MilestoneABC for FitnessTake 10GoNoodle
Started19344
Completed19344
Not completed000

Outcome measures

PrimaryChange in Use of Movement Integration Strategies (Mean Per Day)

Change in self-reported use of movement integration strategies per day. Teachers will complete a weekly log of movement integration product implementation. To complete the log, each teacher will log onto a password-protected website. Teachers will indicate the number of MI product uses per day. If teachers fail to complete the log they will receive an email reminder.

Time frame:
5 school days (Data was averaged across the 5 days) at baseline (teachers did not have the movement integration product) and outcome (one week following baseline when teachers were provided the movement integration product)
Reported as:
Mean · Change in movement strategy use per day
Change in Use of Movement Integration Strategies (Mean Per Day)
Change in movement strategy use per dayABC for FitnessTake 10GoNoodle
Change in Use of Movement Integration Strategies (Mean Per Day)0.4 (-0.1 to 0.7)0.1 (-0.1 to 0.2)0.8 (0.1 to 1.4)

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ABC for Fitness0/19 (0%)0/19 (0%)0/19 (0%)
Take 100/34 (0%)0/34 (0%)0/34 (0%)
GoNoodle0/4 (0%)0/4 (0%)0/4 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)ABC for FitnessTake 10GoNoodleTotal
Mean45.3 ± 10.648.6 ± 5.939.8 ± 10.246.2 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)ABC for FitnessTake 10GoNoodleTotal
Female1934457
Male0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ABC for FitnessTake 10GoNoodleTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American1232044
White70411
More than one race0000
Unknown or Not Reported0202
Region of Enrollment
Region of Enrollment(participants)ABC for FitnessTake 10GoNoodleTotal
United States1934457
08

Study locations

1 site
  • University of South Carolina
    Columbia, South Carolina 29205, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — We will not share IPD data.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in May 2022, 43 months.

Results were first posted in Jan 2025, 2 years 8 months after primary completion.

Of 73 non-industry phase 1 interventional studies under Motor Activity, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 43 months is above that.

Counting every sponsor, half of 75 studies reached it within 20 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2017
First posted
Jan 9, 2018
StartActual
Oct 1, 2018
Primary completionActual
May 1, 2022
CompletionActual
May 1, 2022
Results first posted
Jan 24, 2025
Last update
Jan 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03394846
Responsible party
R. Glenn Weaver (Assistant Professor, University of South Carolina) — Principal investigator
First posted
Jan 9, 2018
Start date
Oct 1, 2018
Primary completion
May 1, 2022
Completion
May 1, 2022
Results posted
Jan 24, 2025
Last update
Jan 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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