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Physical ActivityEarly Phase 1NCT03394846

Classroom Activities

A Early Phase 1 study testing Test of Existing MI Products in people with Physical Activity, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
Test of Existing MI Products
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 1 May 2022
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Carolina

    Columbia, South Carolina, 29205

Other trials in United States

About this study

Official title: Testing Products to Increase Children's Physical Activity in the Classroom: Identifying What Works and What Doesn't

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.

Being tested
Test of Existing MI Products
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test of Existing MI ProductsBehavioural

    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).

Study groups in NCT03394846
Study groupRoleWhat they receive
Test of Existing MI ProductsExperimentalWe will test the impact of three widely available MI products (GoNoodle, Take10, ABC for Fitness) on students' physical activity with 60 elementary classroom teachers.
Receives: Behavioral: Test of Existing MI Products

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2018
  2. Study start1 Oct 2018
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03394846
Sponsor's protocol ID
Pro00069012
Status last verified
Jan 2025
First submitted
10 Nov 2017
Last updated
24 Jan 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will not share IPD data.

Publications

  • Weaver RG, Dugger R, Burkart S, von Klinggraeff L, Hunt ET, Beets MW, Webster CA, Chen B, Armstrong B, Adams EL, Rehling J. Classroom teachers' "off-the-shelf" use of movement integration products and its impact on children's sedentary behavior and physical activity. Transl Behav Med. 2022 Dec 30;12(12):1116-1123. doi: 10.1093/tbm/ibac055.

    PubMed 35998100

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Test of Existing MI Products in people with Physical Activity, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Use of Movement Integration Strategies (Mean Per Day) (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)). 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 NCT03394846, 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 24 Jan 2025.

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