Motor ActivityMPLNCT02851030
Move, Play, Learn! Creating Active Classrooms in Early Care and Education Centers
A study testing Move, Play, Learn! in people with Motor Activity, run by University of North Carolina, Chapel Hill.
Trial summary
Increasing physical activity (PA) and limiting sedentary time are important for many aspects of a young child's wellbeing. However, young children's PA is often limited, and instead preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more than 7 million U.S. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Move, Play, Learn!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to May 2017
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Centers in which teachers work must have at least a 2-star rating or a faith-based designation on NC's quality rating \& improvement system (1 to 5 star scale). Faith-based centers have their own licensing designation separate from this rating system but will also be included.
- Must be a child care teacher.
Who cannot join
- Unwilling to participate in the intervention program.
About this study
Increasing physical activity (PA) and limiting sedentary time are important for many aspects of a young child's wellbeing. However, young children's PA is often limited, and instead preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more than 7 million U.S. children younger than 5 attend center-based child care, the early care and education (ECE) setting is an important source of PA for young children. Thus, PA promotion efforts in ECE programs are crucial to increasing the activity levels of young children, although few interventions exist and most have limited success.
Classroom teachers are important gatekeepers to physical activity in ECE classrooms, as they can determine how active children are in their care. However, teachers often hesitate to implement physical activity in their classrooms. Teachers' attitudes about PA, confidence in modifying children's PA, and their own physical abilities can influence the amount of activity they provide and how they interact with children to support PA. Few models exist to enhance teachers' skill in promoting children's activity, although such an approach could result in more sustainable outcomes. Innovative approaches to physical activity promotion are needed, which engage teachers through training, ongoing technical assistance, and easy-to-use resources.
Read more
This project aims to improve children's physical activity through the Move, Play, Learn! intervention, an intervention designed to alter the behavior of classroom teachers to increase PA in children (3-5 years old) enrolled in ECE programs through a novel, behavioral coaching approach.
To evaluate the 10-week intervention, 32 classrooms in ECE centers will be recruited and randomly assigned to the Move, Play, Learn! intervention or a waitlist control. Teachers in the intervention arm will attend training workshops to learn how children's activity can be increased using natural opportunities across the child care day and how teacher engagement with children can impact activity outcomes. Teachers will be asked to modify typical classroom activities to be more active, using strategies and resources (e.g., how-to videos, pocket activity cards) and will be asked to modify their interactions with children to support PA. Goal setting, self-monitoring, and tailored feedback will facilitate behavior change.
Read the detailed description
Study Overview
The intervention program will be delivered as a randomized control study, with half of the 32 participants Move, Play, Learn intervention immediately and the other half receiving the intervention in a waitlist control format. Participants will begin the study first with baseline surveys and 5 days of accelerometry to assess current physical activity practices within participating classrooms. Then, if participants are randomized to the intervention arm, participants will proceed with the intervention as described elsewhere. If randomized to the waitlist control, participants will be encouraged to continue with normal classroom activities. At the end of the intervention, teachers will complete the same surveys and accelerometry at baseline as well as a participant satisfaction survey. This will end the teachers' participation in the project.
At baseline, parents will be asked to provide demographic information about participating children. Children will be asked to wear accelerometers on the same 5 days as the teacher during baseline and follow-up periods. This data collection will be done during a school week (Monday-Friday), when children are attending center-based case.
Recruitment
Recruitment efforts will be targeted toward licensed child care centers in Orange, Chatham, Durham, Alamance, Wake, and Guilford Counties. A list of such facilities is publicly available through an online database maintained by the North Carolina (NC) Division of Child Development and Early Education's (http://ncchildcaresearch.dhhs.state.nc.us/search.asp). Study staff will contact directors at these child care centers and ask for their assistance distributing study flyers to their staff. Flyers will instruct interested providers and parents to contact the study office.
Randomization
Centers will be randomized in two sets, once halfway through baseline data collection and the other half at the end of baseline data collection. At these randomization time points, the Principal Investigator (PI) will generate a randomization table using a permuted block approach with block sizes of 2 to ensure balance between study arms at any given enrollment time point. The randomization table will be in excel format and include sequential numbers and randomization assignment (intervention or control). The PI will apply the randomization table to the list of centers to determine study arm assignment. The PI will notify centers of their assignment into either the intervention or control arm. Centers in the intervention arm will have immediate access to Move, Play, Learn! Intervention while the control arm will have delayed access to the program; after follow-up measures are collected.
Power Calculation
Investigators will compare the changes in child physical activity using the baseline and post-intervention accelerometer measures among children in classrooms randomized to Move, Play, Learn! intervention compared to children in classrooms randomized to the waitlist control group. The sample size (n=26) is sufficient to measure modest increases in physical activity; although more is expected, by measuring activity levels of 7 children per center, investigators can detect even a 7% increase (approximately 12 minutes per day) in non-sedentary physical activity, to put the effect size in terms of a measurable outcome.
Based on previous work and other similar studies, investigators estimate a 0.55 effect size in the Move, Play, Learn! intervention. Because children are clustered within ECE classrooms, this needs to be accounted in the power calculation. Based on previous studies, the ECE center intra-class coefficient (ICC) estimate is 0.12 for nonsedentary time. This ICC is appropriate to use for the power calculation since only 1 classroom per center will be recruited; thus the center and classroom are interchangeable here. It is anticipated that an average of 7 children per classroom will be recruited. Using a two-sided test of significance at α=0.05, an ICC=0.12, and cluster size=7 children per classroom, a sample size of 13 centers per arm (91 children per arm) will provide at least 80% power to detect the anticipated change in physical activity (effect size=0.55. Accounting for 15% attrition of classroom teachers, investigators will recruit and randomize 32 ECE classrooms (16 per arm) with a minimum of 7 children per classroom for a total of 224 children.
Statistical Analysis
The primary analysis will test the hypothesis under the intent-to-treat principle (ITT) using longitudinal, mixed effects models that will account for the correlation of child physical activity by ECE center. As shown below, each model will include a random intercept (b0) and fixed effects for the intervention (B2) and baseline (B1) to test if the mean change in physical activity is different between the two arms.
Child PA10 wk = β0 + β1Child PAbaseline + β2Intervention + β3Center + b0 + e
Additional analyses will 1) adjust for baseline covariates considered to be relevant to change in physical activity; 2) adjust for baseline variables distributed differently between study arms; 3) test interaction terms between treatment group and other covariates; and 4) examine completers only.
Missing data
The study team will make every effort to minimize missing data; however, some missing data are expected to occur. Investigators will examine the potential for bias from non-ignorable, non-response using two methods. First, investigators will compare respondents and non-respondents to see if there are systematic differences in non-missing variables. Next, investigators will assess the type of missingness, whether missing completely at random (MCAR) or missing at random (MAR) or missing not at random (MNAR). If data are either MAR or MNAR investigators will employ multiple imputation to impute missing PA values. Sensitivity analyses will be conducted to determine the effect of these missing data on intervention effect estimates and robustness of results using different estimation methods.
- Conditions
- Motor Activity
- Being tested
- Move, Play, Learn!
- Keywords
- Child, Preschool, Child Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move, Play, Learn!Behavioural
Participants will attend a 4 hour workshop at the beginning of the intervention and the midpoint, covering project information, physical activity for young children, and distribution of project materials. Teachers will focus on one area of their child care day for 2 weeks each: indoor structured PA, outdoor structured PA, transitions between activities, and circle time. Participants will receive an email newsletter introducing the topic and will implement short (10 minutes) classroom activities. Teachers will also be educated about teacher PA practices, focusing on 1 behavior during each segment. Research staff will contact the teachers weekly to provide technical assistance, help teachers troubleshoot any issues that participants have with the activities, and provide encouragement.
| Study group | Role | What they receive |
|---|---|---|
| Move, Play, Learn! Intervention | Experimental | This arm will receive the 10-week Move, Play, Learn! intervention immediately. Receives: Behavioral: Move, Play, Learn! |
| Waitlist Control | No intervention | This arm will receive the 10-week intervention once follow-up measures on the primary outcome have been collected for both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily minutes of child accelerometer-measured non-sedentary physical activity
Based on 5 weekdays of accelerometry collected with ActiGraph GT3X monitors at baseline and at follow up (10 weeks after baseline), investigators will summarize average minutes of daily, accelerometer-measured non-sedentary time for children using Pate cutpoints developed for young children. Non-sedentary time includes light, moderate, and vigorous activity.
Measured: 10 weeks
Secondary outcomes (2)
Change in daily minutes of teacher accelerometer-measured non-sedentary physical activity
Similar to the child measure, based on 5 weekdays of accelerometry collected with ActiGraph GT3X monitors at baseline and at follow up (10 weeks after baseline), investigators will summarize average minutes of daily, accelerometer-measured non-sedentary time for teachers using National Health and Nutrition Examination Survey (NHANES) cutpoints developed for adults. Again, non-sedentary time includes light, moderate, and vigorous activity.
Measured: 10 weeks
Classroom physical activity environment as measured by the Environment and Policy Assessment and Observation (EPAO-SR)
Based on teachers' self-report of the classroom environment for physical activity on the EPAO-SR, which includes provisions and practices, we will compute one overall environment score for each teachers' classrooms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Mazzucca, University of North Carolina, Chapel Hill
- Investigators
- Stephanie Mazzucca, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851030
- Sponsor's protocol ID
- 16-1972
- Acronym
- MPL
- Status last verified
- Sep 2017
- First submitted
- 19 Jul 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This study is a small, pilot study that is intended to establish the feasibility of the intervention approach. It is not intended to create a larger data set for others to use given its small scope and size.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move, Play, Learn! Creating Active Classrooms in Early Care and Education Centers
- ClinicalTrials.gov ID
- NCT02851030
- Acronym / sponsor ID
- MPL / 16-1972
- Conditions
- Motor Activity
- Keywords
- Child, Preschool, Child Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Increasing physical activity (PA) and limiting sedentary time are important for many aspects of a young child's wellbeing. However, young children's PA is often limited, and instead preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more than 7 million U.S. children younger than 5 attend center-based child care, the early care and education (ECE) setting is an important source of PA for young children. Thus, PA promotion efforts in ECE programs are crucial to increasing the activity levels of young children, although few interventions exist and most have limited success.
Classroom teachers are important gatekeepers to physical activity in ECE classrooms, as they can determine how active children are in their care. However, teachers often hesitate to implement physical activity in their classrooms. Teachers' attitudes about PA, confidence in modifying children's PA, and their own physical abilities can influence the amount of activity they provide and how they interact with children to support PA. Few models exist to enhance teachers' skill in promoting children's activity, although such an approach could result in more sustainable outcomes. Innovative approaches to physical activity promotion are needed, which engage teachers through training, ongoing technical assistance, and easy-to-use resources.
This project aims to improve children's physical activity through the Move, Play, Learn! intervention, an intervention designed to alter the behavior of classroom teachers to increase PA in children (3-5 years old) enrolled in ECE programs through a novel, behavioral coaching approach.
To evaluate the 10-week intervention, 32 classrooms in ECE centers will be recruited and randomly assigned to the Move, Play, Learn! intervention or a waitlist control. Teachers in the intervention arm will attend training workshops to learn how children's activity can be increased using natural opportunities across the child care day and how teacher engagement with children can impact activity outcomes. Teachers will be asked to modify typical classroom activities to be more active, using strategies and resources (e.g., how-to videos, pocket activity cards) and will be asked to modify their interactions with children to support PA. Goal setting, self-monitoring, and tailored feedback will facilitate behavior change.
Detailed description
Study Overview
The intervention program will be delivered as a randomized control study, with half of the 32 participants Move, Play, Learn intervention immediately and the other half receiving the intervention in a waitlist control format. Participants will begin the study first with baseline surveys and 5 days of accelerometry to assess current physical activity practices within participating classrooms. Then, if participants are randomized to the intervention arm, participants will proceed with the intervention as described elsewhere. If randomized to the waitlist control, participants will be encouraged to continue with normal classroom activities. At the end of the intervention, teachers will complete the same surveys and accelerometry at baseline as well as a participant satisfaction survey. This will end the teachers' participation in the project.
At baseline, parents will be asked to provide demographic information about participating children. Children will be asked to wear accelerometers on the same 5 days as the teacher during baseline and follow-up periods. This data collection will be done during a school week (Monday-Friday), when children are attending center-based case.
Recruitment
Recruitment efforts will be targeted toward licensed child care centers in Orange, Chatham, Durham, Alamance, Wake, and Guilford Counties. A list of such facilities is publicly available through an online database maintained by the North Carolina (NC) Division of Child Development and Early Education's (http://ncchildcaresearch.dhhs.state.nc.us/search.asp). Study staff will contact directors at these child care centers and ask for their assistance distributing study flyers to their staff. Flyers will instruct interested providers and parents to contact the study office.
Randomization
Centers will be randomized in two sets, once halfway through baseline data collection and the other half at the end of baseline data collection. At these randomization time points, the Principal Investigator (PI) will generate a randomization table using a permuted block approach with block sizes of 2 to ensure balance between study arms at any given enrollment time point. The randomization table will be in excel format and include sequential numbers and randomization assignment (intervention or control). The PI will apply the randomization table to the list of centers to determine study arm assignment. The PI will notify centers of their assignment into either the intervention or control arm. Centers in the intervention arm will have immediate access to Move, Play, Learn! Intervention while the control arm will have delayed access to the program; after follow-up measures are collected.
Power Calculation
Investigators will compare the changes in child physical activity using the baseline and post-intervention accelerometer measures among children in classrooms randomized to Move, Play, Learn! intervention compared to children in classrooms randomized to the waitlist control group. The sample size (n=26) is sufficient to measure modest increases in physical activity; although more is expected, by measuring activity levels of 7 children per center, investigators can detect even a 7% increase (approximately 12 minutes per day) in non-sedentary physical activity, to put the effect size in terms of a measurable outcome.
Based on previous work and other similar studies, investigators estimate a 0.55 effect size in the Move, Play, Learn! intervention. Because children are clustered within ECE classrooms, this needs to be accounted in the power calculation. Based on previous studies, the ECE center intra-class coefficient (ICC) estimate is 0.12 for nonsedentary time. This ICC is appropriate to use for the power calculation since only 1 classroom per center will be recruited; thus the center and classroom are interchangeable here. It is anticipated that an average of 7 children per classroom will be recruited. Using a two-sided test of significance at α=0.05, an ICC=0.12, and cluster size=7 children per classroom, a sample size of 13 centers per arm (91 children per arm) will provide at least 80% power to detect the anticipated change in physical activity (effect size=0.55. Accounting for 15% attrition of classroom teachers, investigators will recruit and randomize 32 ECE classrooms (16 per arm) with a minimum of 7 children per classroom for a total of 224 children.
Statistical Analysis
The primary analysis will test the hypothesis under the intent-to-treat principle (ITT) using longitudinal, mixed effects models that will account for the correlation of child physical activity by ECE center. As shown below, each model will include a random intercept (b0) and fixed effects for the intervention (B2) and baseline (B1) to test if the mean change in physical activity is different between the two arms.
Child PA10 wk = β0 + β1Child PAbaseline + β2Intervention + β3Center + b0 + e
Additional analyses will 1) adjust for baseline covariates considered to be relevant to change in physical activity; 2) adjust for baseline variables distributed differently between study arms; 3) test interaction terms between treatment group and other covariates; and 4) examine completers only.
Missing data
The study team will make every effort to minimize missing data; however, some missing data are expected to occur. Investigators will examine the potential for bias from non-ignorable, non-response using two methods. First, investigators will compare respondents and non-respondents to see if there are systematic differences in non-missing variables. Next, investigators will assess the type of missingness, whether missing completely at random (MCAR) or missing at random (MAR) or missing not at random (MNAR). If data are either MAR or MNAR investigators will employ multiple imputation to impute missing PA values. Sensitivity analyses will be conducted to determine the effect of these missing data on intervention effect estimates and robustness of results using different estimation methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Move, Play, Learn! Intervention | Experimental | Behavioral: Move, Play, Learn!This arm will receive the 10-week Move, Play, Learn! intervention immediately. |
| Waitlist Control | No intervention | –This arm will receive the 10-week intervention once follow-up measures on the primary outcome have been collected for both groups. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Centers in which teachers work must have at least a 2-star rating or a faith-based designation on NC's quality rating \& improvement system (1 to 5 star scale). Faith-based centers have their own licensing designation separate from this rating system but will also be included.
- Must be a child care teacher.
Key exclusion criteria (1 listed)
- Unwilling to participate in the intervention program.
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 |
|---|---|---|
| Move, Play, Learn!Participants will attend a 4 hour workshop at the beginning of the intervention and the midpoint, covering project information, physical activity for young children, and distribution of project materials. Teachers will focus on one area of their child care day for 2 weeks each: indoor structured PA, outdoor structured PA, transitions between activities, and circle time. Participants will receive an email newsletter introducing the topic and will implement short (10 minutes) classroom activities. Teachers will also be educated about teacher PA practices, focusing on 1 behavior during each segment. Research staff will contact the teachers weekly to provide technical assistance, help teachers troubleshoot any issues that participants have with the activities, and provide encouragement. | Behavioural | Move, Play, Learn! Intervention |
Primary outcome
Change in daily minutes of child accelerometer-measured non-sedentary physical activity
Time frame: 10 weeks
Based on 5 weekdays of accelerometry collected with ActiGraph GT3X monitors at baseline and at follow up (10 weeks after baseline), investigators will summarize average minutes of daily, accelerometer-measured non-sedentary time for children using Pate cutpoints developed for young children. Non-sedentary time includes light, moderate, and vigorous activity.
2 secondary outcomes
Change in daily minutes of teacher accelerometer-measured non-sedentary physical activity
Time frame: 10 weeks
Classroom physical activity environment as measured by the Environment and Policy Assessment and Observation (EPAO-SR)
Time frame: 10 weeks
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 14 Sep 2017.
- Individual participant dataSharing planned: No. This study is a small, pilot study that is intended to establish the feasibility of the intervention approach. It is not intended to create a larger data set for others to use given its small scope and size.
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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.
Stephanie Mazzucca principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Move, Play, Learn! in people with Motor Activity, run by University of North Carolina, Chapel Hill.
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 2 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 14 Sep 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?
Change in daily minutes of child accelerometer-measured non-sedentary physical activity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2017.