PLAY: An Intervention to Improve Motor Skills in Young Children
Phase: NA
Conditions: Physical Activity, Fundamental Motor Skills, Development, Child, Self-regulation
Sponsor: Pennington Biomedical Research Center

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Protocol Title: PLAY: An Intervention to Improve 
Motor Skills in Young Children
PI Name: Amanda E. Staiano, PhD, E. Kipling Webster, PhD
Sub-Investigator’s Name(s): Robert L. Newton, Jr., PhD, Robbie Beyl, 
PhD
Protocol Version Date: November 23, 2020
Pennington Biomedical IRB FWA 00006218
Approved November 24, 2020
NCT # NCT03901300

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Preschoolers spend 4 hours/day in front of a screen,[1] while fewer than one-
quarter engage in the recommended two hours of daily physical activity (PA).[2, 3] The 
decline in PA, increase in screen-based behaviors, and onset of obesity during 
preschool years have been linked to lifetime risk of obesity and related comorbidities.[4, 
5] However, emerging evidence indicates that “screen time” can actually be leveraged
as a tool to increase children’s PA and promote healthy weight. Specifically, PA 
interventions delivered over digital devices can provide real-time encouragement for 
children to be physically active. Prior interventions delivered over mobile devices were 
effective in increasing PA levels, including our own P-Mobile study that provided 
behavioral strategies to parents of children aged 6 to 10 years.[6, 7] 
When considering how to support and motivate parents whose children are 
preschool-aged, teaching and modeling fundamental motor skills (FMS) are critical to 
enable children’s PA.[8, 9] FMS like running, jumping, or throwing a ball, are basic, goal-
directed movement patterns developed in early childhood that provide a foundation for 
children to be physically active and competent movers.[10] These skills enable a child to 
function independently in their surrounding environment, engage with peers, and 
contribute to their ability to be physically active.[8, 10] Evidence has shown that children 
must establish a minimal level of FMS proficiency to continue participating in PA 
opportunities as they age.[8, 9, 11-13] FMS and PA behaviors have a dynamic and 
reciprocal relationship.[8, 9] Children with higher levels of FMS are more physically 
active both during childhood [14-16] and into adolescence.[17-20] Research has 
indicated that the preschool years are an opportune time for children to learn and 
reinforce these skills.[21] However, our preliminary data indicate that children in our 
community are in the 32nd percentile for FMS based on their age. With inadequate FMS 
competency, a child is less likely to engage in physical activities based on lack of 
prerequisite skills and abilities that are foundational to FMS,[8, 9, 11-13] whereas a child 
with adequate FMS competency tends to be more physically active and less likely to be 
overweight or obese.[22] Indeed, the PA trajectory model[8] indicates that FMS 
competence is a critical component to a child’s risk of obesity and contributes to PA, 
physical fitness, and perceived movement competence.[9] Moreover, FMS promote self-
regulatory abilities including managing emotions, focusing attention, and inhibiting 
behavior.[23] Behavioral self-regulation is important for academic readiness,[24] coping 
with stress, and regulating health behaviors that contribute to obesity.[25] Therefore, a 
PA intervention for preschoolers should focus on developing FMS competence.
The goal of “PLAY” is to adapt and test a developmentally appropriate 
intervention delivered on a mobile app to parents, with the goal of teaching FMS 
proficiency to their preschool-aged children (ages 3 to 5 y). We will randomize up to 
74 child-parent dyads (children 3 to 5 y of age) to this intervention, with up to 37 parents 
using the FMS app and up to 37 using a version of the app that promotes unstructured 
PA as a comparator group. Parents in the FMS condition will access instructional 
lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, 
structured FMS instruction time to their child over a 12-week period (12 min/day, 5 
days/week). Parents in the comparator arm will use a version of the app that provides 
instructional lessons to promote the equivalent amount (12 min/day, 5 days/week over 
12-weeks) of unstructured PA for their child. Parents will guide the intervention, as 
parental support, modeling, and co-participation predict children’s engagement in 
PA.[26-29] 
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The specific aims are as follows:
Specific Aim 1: To examine the feasibility and acceptability of a 12-week FMS 
intervention delivered through a mobile app to parents and children.
Specific Aim 2: To test the hypothesis that a 12-week FMS intervention 
delivered through a mobile app will improve children’s FMS, compared to the 
unstructured PA app comparator group.
Exploratory Aims: To test the hypothesis that a 12-week FMS intervention 
delivered through a mobile app will improve children’s PA levels, perceived 
movement competence, and academic readiness (i.e. self-regulation skills), 
compared to the unstructured PA app comparator group; to examine FMS as a 
mediator of changes in PA levels; and to examine sustained effects on outcomes 
12-weeks following the end of the intervention.
This project provides a unique contribution by furthering our understanding of how a 
parent-targeted, app-based intervention that targets FMS development impacts 
children’s FMS, PA levels, perceived movement competence, and academic readiness. 
Given the ubiquity of digital devices in parents’ and children’s daily lives, this project will 
provide important information on whether or not, and in what ways, apps may serve as 
an intervention tool to educate, prompt, and promote FMS development and PA in 
children while providing the informal, fluid, and social learning environment that is most 
comfortable to young children and their parents.
Inclusion and Exclusion Criteria
Inclusion Criteria (child):

3-5 years of age

Physically capable of exercise

Has no parent-reported mobility limitations that impairs performance of
fundamental motor skills
Exclusion Criteria (child):

Gross Motor Quotient at “gifted or very advanced” based on the Test of Gross
Motor Development (TGMD-3)
Inclusion Criteria (parent):

Has a smart phone

Willing to download and use the app

Has no plans to move outside the greater Baton Rouge area during the study
period

Has no self-reported mobility limitations that impairs modeling of fundamental
motor skills
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Number of Subjects
The participants in this study will be up to 74 dyads, each consisting of one child and 
one parent (up to 144 persons total). If the parent has multiple qualifying children, the 
parent must select one eligible child to enroll in the study. The demographics of Baton 
Rouge provide an opportunity to examine this intervention in a high-risk population, 
given 46% of city residents are non-Hispanic black and 28% of children under the age 
of 5 live in households below the federal poverty level.[30] We will not limit the 
intervention based on income level but rather recruit from the general population, with 
the goal to test the feasibility and effectiveness for generalizability.
Recruitment Methods
We will use multiple strategies that were effective in our prior pediatric trials, 
including but not limited to advertising in preschools and via community and church 
organizations and using email newsletters, list serves, and social media. Members of 
the investigative team have been directly involved in successful pediatric recruitment, 
collectively recruiting 4500 children into PA-related research.
Study Timelines
See Table 1 below for the detailed study timeline. The first half of Year 1 will be 
used to finalize the intervention protocol and adapt the app, while the second half will be 
used to begin recruitment and the intervention. The anticipated duration to enroll all 
study participants will be 12 months. The data collection period is anticipated to last 
approximately 15 months. Data will be analyzed and published in the final half of Year 
2. 
Table 2. Study Timeline
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Procedures Involved
Telephone Screen. Research staff will perform a phone screen with parents to 
determine initial eligibility.
Screening visit. Research staff will conduct screening, consenting, and 
assessments in YMCA branches or other community locations, strategically chosen for 
convenience to the majority of residents, available classroom space for assessments, 
and our prior history of conducting research assessments in these sites. The parent will 
sign the consent form. Assessments may be scheduled in the afternoon/evening hours 
and Saturdays as convenient for the parents. The parent/child will be formally oriented 
to the study during this visit and receive detailed information on the purposes, goals, 
procedures, and timeline. Parents will confirm that they and their child have no mobility 
limitations, and children will complete the TGMD-3 to confirm eligibility. The parent will 
receive an accelerometer for the child to wear for 7-days. 
Baseline visit (week 0). Within 2-3 weeks of the screening visit, children will return 
to the YMCA or community location for anthropometric assessments and the perceived 
movement skill competence survey, and parents will return the accelerometer and 
complete surveys. In advance of randomization, Co-I and statistician Dr. Beyl will 
generate a sex-stratified adaptive randomization taking into account baseline FMS. The 
study staff will help to download the app onto the parent’s smartphone/tablet and select 
the FMS version or unstructured PA version based on randomization. If participant 
cannot attend the Baseline visit within 3 weeks of the Screening visit, screening 
measures must be repeated.
End of treatment visit (week 12) and follow-up (week 24). The child/parent will 
return to the YMCA or community location to complete assessments at end of 
intervention (+/- 1 week) and again 12-weeks later (+/- 2 weeks). Assessments include 
the TGMD-3, anthropometry, and the perceived movement skill competence. The 
parent will complete surveys and return the accelerometer (which will be mailed to the 
parent 2 weeks prior to the visit for the child to wear for 7-days). At the week 12 and 
week 24 visits, the accelerometer will be downloaded to ensure wear compliance was 
met. If the child did not meet wear time compliance, they will counselled on compliance 
and will be issued another accelerometer to wear for 7 days along with a pre-stamped 
envelope to mail it back to Pennington.
PLAY App
The PLAY app (which contains a FMS section and unstructured PA section) is 
developed by an app development company which will create the app using the content 
and videos developed by the investigators during the first 6 months. 
Usability testing will include up to 8 parents not enrolled in the study who will beta 
test the app. Of those, up to 4 will be randomly assigned to the Unstructured Play 
Condition and up to 4 will be randomly assigned to the Fundamental Motor Skill 
Condition. Usability testing will be conducted with parents from the Baton Rouge area 
who have children that are 3-6 years of age. Parents will be asked to come to a 1 hour 
visit where study staff will download the fully programmed app to their smartphones. 
Parents will be asked to use the app for up to four weeks. After completing the usability 
testing, parents will be asked to complete an exit interview over the phone or in person 
where study staff will collect information on the acceptability and feasibility of the app. 
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They will also be asked to rate their satisfaction of the app with regards to design, 
appeal, and functionality by completing a survey. The phone interview will also collect 
feedback regarding suggestions for app improvement and users’ impressions of the app 
notifications. App usage data will be collected by the software company and provided to 
PBRC. Parents who complete usability testing will be compensated a total of $50.00. 
After field usability has concluded, the software company will incorporate the 
improvements to the app and resolve any remaining issues. Parents who complete 
usability testing will be consented separately and will not be eligible to complete the 
main study. 
Parents in both conditions will download and use the PLAY app during the main 
study. To standardize the appearance and usability of the app across the two 
conditions, the two versions of the app will mimic each other in terms of design and 
layout. Parents in the FMS condition will have access to the FMS instructional lessons, 
peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured 
FMS instruction time to their child over a 12-week period (12 min/day, 5 days/week). 
Parents in the Unstructured PA (defined as free play that is encouraged by not 
dictated/guided by parents) condition will have access to the unstructured PA lessons 
and videos to promote the equivalent amount (12 min/day, 5 days/week over 12-weeks) 
of unstructured PA for their child. 
All communication with parents (outside of assessment visits) will occur via mobile 
device (smartphone or tablet/iPad). However, if usage data indicate that the parent is 
not regularly using the app, a research staff member may call the parent to ensure there 
are no technical difficulties. Push notifications will be sent via the app to prompt the 
parent to read each week’s lesson (1x/week) and to prompt the parent and child to 
engage in the activity break (4x/week). The principles of shaping[33] will be used to 
employ a reinforcement schedule to promote continued motivation for the child during 
the 12-week intervention. At the baseline visit following randomization, the parent will be 
instructed by the research staff on how to provide reinforcement to their child in the form 
of a reinforcement schedule. The reinforcement schedule is based on a reward system 
in which the child earns stars for each day they complete a 12-minute break. Parents 
will have the option to provide non-food rewards to their children as they complete 5 
stars each week. See similarities and differences of each condition in Table 2.
Table 2. PLAY App: Features of each condition.
Fundamental Motor Skills
Unstructured Physical 
Activity 
Child Physical 
Activity
720 min of directed instruction on motor skills 
over 12 wks (12-min/d, 5 d/wk)
720 min of unstructured PA 
over 12 wks (12-min/d, 5 d/wk)
Parent Lesson
Parent reads lesson 1x/week on each targeted 
FMS (e.g. description of a proficient “hop”)
Parent reads lesson and watches 
voice-over powerpoint slide with 
lesson 1x/week on PA support 
(e.g. how to make time for PA)
Peer Modeling 
Videos
Parent and child watch video of peers modeling 
each targeted FMS (e.g. performing a “hop”)
None
Activity Break
Practice, modeling, and reinforcement of each 
targeted FMS (e.g. hopping game)
Free play examples of unstructured 
PA (e.g. take child to the park, play 
songs for a dance party)
Push 
Notifications
5x/wk to prompt each new lesson and 
12-min activity break 
Rewards and 
Reinforcement
Point system reinforcement schedule
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Fundamental motor skill condition. Parents in the FMS condition will be provided 
access to the FMS features on the app, following a 12-week curriculum focused on six 
key FMS (3 locomotor, 3 object control) that we selected to be challenging but 
developmentally appropriate (i.e. hop, throw, slide, kick, vertical jump, catch; each 
taught over one week during weeks 1-6 and then repeated during weeks 7-12). Parents 
will assist the child in the engagement of at least 12 min of structured FMS practice 
daily, 5 days/week, including viewing videos and practicing the skills through the 
activities described on the app. For example, on Week 1 Day 1, the parent will receive a 
push notification to open the app and access the first themed lesson, “Hop.” The parent 
will read a brief instructional lesson about the targeted FMS, including a description of a 
proficient “hop.” The parent and child will then view a brief video of the demonstrated 
FMS, and then engage in a 12-min activity break designed to help the parent model the 
skill and provide the child with practice. Total exposure will accumulate to 720 min of 
directed instruction over 12 weeks, a dosage that aligns with prior interventions that 
effectively improved children’s FMS.[34, 35] 
Theoretical basis. Behavioral scaffolding81 and social cognitive theory[36, 37] 
informs the FMS approach. The child and parent learn by viewing a series of video 
segments of children performing motor skills that increase in complexity. Behavioral 
scaffolding is a cognitive learning approach to problem solving that allow children to 
master skills beyond his or her current ability[38, 39] and is effective in helping parents 
assist children in attaining behavior goals.[40] According to social cognitive theory, for 
modeling to effectively elicit behavior change, the child must undergo a process 
involving attention, retention, reproduction, and motivation.[36, 37] Attention is garnered 
through the app via videos of peers with auditory and visual stimuli to enhance 
arousal/engagement. Retention is reinforced through multiple exposures to the video 
segments along with push notifications to parents (SMS text message) to reinforce 
behavioral change strategies including FMS practice. Reproduction is elicited through 
the child producing the modeled activities. Motivation is encouraged intrinsically through 
perceived competence and extrinsically via encouragement in the form of video and text 
files. 
 Peer modeling videos and behavioral scaffolding. Brief videos viewed by the parent 
and child will be used as a model to provide scaffolding for the child to improve FMS 
competency. Our team has begun recording brief videos of 
preschool-aged children (diverse in age, sex, and 
race/ethnicity) modeling 6 FMS, with each video 
demonstrating 5 progressively more difficult process-oriented 
components of the skill (30 videos in total). Additional brief 
videos provide examples of the games and activity breaks. 
Scaffolding personalizes the experience such that the child is 
rewarded for mastering the demonstrated skill, allowing the 
parent to move on to the next video in the app. For example, 
for overhand throw children will begin with a contralateral 
step, then wind-up, followed by trunk rotation/follow through. 
Prompts appear on each video to provide clear, concrete criterion to trigger the parent 
to advance to the next video (e.g. “Once your child is stepping with the opposite foot 
(see video) you can move to the next stage”). Once the child masters one performance 
component, which will be highlighted by graphics on the video (e.g. an arrow pointing to 
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the opposite foot), parents advance to the next level and the child receives 
reinforcement through visual cues. If the child has trouble mastering a skill, 
modifications are available to minimize frustration (e.g., jump on both legs if the child 
cannot hop on one leg). If the child reaches mastery, the final video for each skill 
encourages improved motor performance (e.g. a higher hop or longer throw) to avoid 
boredom or ceiling effect.
Activity breaks. The final component of each lesson is that the parent will guide the 
child through a 12-min activity to practice, model, and 
reinforce the targeted FMS with games/activities (see 
Table 3). mPI Webster developed and tested these 
lessons, demonstrating effectiveness to improve children’s 
motor skill competence with good adherence.[41, 42] A list 
of activities will be provided that allow the parent and child 
to practice the demonstrated skill together with minimal 
equipment (e.g. “Red Light, Green Light”). 
Unstructured PA condition. Parents in the comparator group will access content 
on the app that provides 12-weeks of lessons with ideas for free play to promote their 
child’s unstructured PA. These lessons are adapted to be developmentally appropriate 
for preschoolers using the curriculum we previously developed and tested based on 
social cognitive theory.[6] We selected this comparator arm as it has shown to increase 
children’s PA levels[6] but does not explicitly target FMS or provide structured lessons 
to parents on how to model these skills. The following six topics will be covered: 
stimulus control, making time for child’s free PA, being active in- and outdoors, 
reinforcing PA, reducing sedentary behaviors, and parental co-participation. The free 
play breaks will provide specific strategies to encourage the child’s unstructured PA 
(e.g. take your child to the park or outside, use your phone alarm to remind your child to 
be physically active). 
Table 4. Study Procedure Schedule
Screening 
Visit
Baseline 
(Week 0)
Intervention
End of 
Treatment 
(Week 12)
Follow Up 
(Week 24)
Consent
X
Anthropometric 
Measures
X
X
X
Parent 
Surveys
X
X
X
X
Child Survey
X
X
X
TGMD-3
X
X
X
Accelerometer 
(distribute)
X
Accelerometer 
(return)
X
*X
*X
Randomization
X
PLAY App 
download
X
PLAY App use 
(12 weeks)
X
*Accelerometer will be mailed to parents approximately 2 weeks prior to Wk 12 and Wk 24 visits
Table 3. Activity break for “Hop”
Warm-up: Flamingo stand
(30 sec for each foot)
A. Scissor jumps (30 sec)
B. Hop scotch hopping (30 sec)
C. Squats (30 sec)
D. Lava jump! (30 sec)
Repeat A-D 5 times
Cool-down: Balancing act (1 min)
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for the child to wear for 7 days
Study Endpoints
Primary Outcomes. Feasibility will be measured as adherence to the app 
intervention, including number of lessons/videos and activity breaks/videos accessed 
and frequency of interaction with the app. During each week of the intervention, parents 
will complete an acceptability survey over the app to assess satisfaction and usability. 
At the end of the intervention, parents will complete an acceptability survey to assess 
overall satisfaction and usability.
FMS will be assessed using the Test of Gross Motor Development (TGMD-3), a 
direct observation assessment used with children ages 3–10 y. The TGMD-3 is a 
process- and product-oriented assessment to evaluate FMS performance in two 
subscales: locomotor (run, gallop, one-legged hop, skip, jump, and slide) and ball skills 
(two-hand strike, one-hand strike, catch, kick, dribble, overhand throw, and underhand 
throw). By design, these include skills targeted in the intervention. mPI Webster 
demonstrated that the TGMD-3 is a valid and reliable assessment tool.[43, 44] 
Assessments will be filmed and coded by trained research assistants blind to the 
purpose of this project who have reached 98% reliability coding sample administrations 
prior to testing. At the Week 24 visit, participants may be asked to perform three 
additional motor skill tasks: Supine-Timed Up and Go (S-TUG), One-leg Standing 
Balance Test, and the Standing Long jump. 
Exploratory Outcomes. Physical activity levels. The child will wear an Actigraph 
GT3X+BT accelerometer for 7-days on the right hip, which has been validated in 
preschoolers.[45] Minimal wear time is 4 days with ≥10 hours/day (≥1 weekend day) 
and 15-sec epoch length.[46] We will use the cutpoints by Pate et al.[45] to classify 
moderate and vigorous PA, which were validated in preschoolers against indirect 
calorimetry,[45] and the sedentary cutpoint by Evenson et al.,[47] which was validated 
in preschoolers against direct calorimetry.[48]
Perceived movement competence. The Pictorial Scale of Perceived Movement Skill 
Competence[49, 50] will examine a child’s perceived movement competence on the 13 
skills assessed with the TGMD-3[49] and takes approximately 10 min for the child to 
complete. mPI Webster has established reliability with this scale.[49]
Self-regulation skills/academic readiness. Self-regulation skills will be measured by 
the parent using the Devereux Early Childhood Assessment (DECA), 2nd Edition, which 
is a 38-item proxy report with good validity and reliability to measure self-regulation and 
behavioral concerns in children 3 to 5 y.[51] 
Anthropometry. Height and weight will be measured using a stadiometer and 
portable scale, without shoes, and recorded to the nearest 1.0 cm and 0.1 kg. BMI z-
score will be calculated.[52] 
Sociodemographic information and health behaviors. Parents will provide 
information on child’s and parent’s age, sex, race/ethnicity, parental education, food 
security, time spent in away-from-home care, family structure, home environment, and 
household income, as well as health behaviors including media use, prior experience 
with apps, family participation in physical activity, and eating habits. 
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      Household Chaos Questionnaire. Parents will complete the Confusion, Hubbub, and 
Order scale (CHAOS). This 15-item questionnaire will assess household organization, 
noise level, and crowding. [53]
Power analysis.
The estimated effect size is based on a meta-analysis of FMS interventions 
(overall effect size d=0.39).[34, 54] A group size of 28 dyads/group will provide 80% 
power to detect an effect size of 0.33 for change in FMS score at week 12 (α=0.05). We 
will randomize up to 37 dyads/group (total of up to 74 dyads) and assume 20% of dyads 
will drop out by week 12 so that there will be up to 30 dyads/group at end of 
intervention.
Data Analysis
We use intent-to-treat mixed effect linear models. Aims 1 and 2 will be assessed 
using the least square means for the treatment effect from the model. We will include 
covariates to test if biological variables, such as sex, are associated with outcomes. We 
will use mediational analyses to further isolate the effects of FMS changes on 
exploratory outcomes and mixed effect linear models to examine sustained changes at 
week 24. Children will be included regardless of developmental delay, as both typically 
and atypically developing children benefit similarly from FMS interventions.[34] 
Data Management and Confidentiality
The Pediatric Obesity and Health Behavior Laboratory, supervised by Dr. 
Staiano, will have primary responsibility for data collection, data management, manual 
data entry, and data analysis. Dr. Webster’s lab will also be responsible for data 
analysis of the TGMD data. Each participant will be issued a number that will be utilized 
throughout the study. A secure master file linking names and participant numbers will be 
maintained in a confidential computer file accessible only to the investigators. Access to 
data files can be made only with permission of the Principal Investigator. All electronic 
data will be stored in the secure Pennington database and with Dr. Webster’s lab, with 
access given to only necessary, HIPAA-certified staff. All hard copies of data will be 
stored in a secure, locked cabinet at Pennington Biomedical Research Center. Data 
collected at the childcare centers will be securely transported to PBRC by trained staff. 
Data will be stored for 5 years following study completion.
Provisions to Protect the Privacy Interests of Subjects and Monitor the Data to 
Ensure the Safety of Subjects
A. Data Quality and Management
1) Description of Plan for Data Quality and Management – The PIs and Project 
Manager will review all data collection forms on an ongoing basis for data 
completeness and accuracy as well as protocol compliance. A statement 
reflecting the results of the review will be sent to the NIH in the annual report 
(non-competing continuation). Any protocol deviations will be reported to the 
PBRC IRB. Although there are additional reports to be produced by the study 
coordinator as a result of this DSMP, there are no substantive changes to the 
study protocol that might require review by the NIH. 
2) Frequency of Review – The types of data reviewed and frequency of review are 
detailed in the table below.
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Data type
Frequency of review
Reviewer
Subject accrual and 
protocol adherence
Quarterly
Principal Investigators,
Independent Monitor
Adverse event rates
Semi-annually
Principal Investigators, 
Independent Monitor, 
DSMB
Rates of study 
completion
Quarterly
Principal Investigators,
Independent Monitor
Stopping rules report 
regarding statistical 
power implications of 
drop outs and missing 
data
Yearly
Principal Investigators, 
Independent Monitor, 
Biostatistician, DSMB
B. Subject Accrual and Compliance 
1) Measurement and reporting of subject accrual, adherence to inclusion/exclusion
criteria, protocol adherence, and rates of study completion – Review of subject
accrual, adherence to inclusion/exclusion criteria and study procedures as listed
in the protocol, and rates of study completion will occur quarterly. These data will
be reviewed by the study PIs and Independent Monitor.
2) Stopping Rules – Data on subject accrual and completion rates will be
synthesized and evaluated yearly to determine if the study should be terminated.
One of the most likely reasons for early termination is the failure to recruit or
retain participants; therefore, these data will be evaluated yearly to determine if
failure to recruit or attrition is jeopardizing the ability to empirically test the study
aims. These data will be reviewed by the study PIs and Independent Monitor,
with consultation from the statistician, and by the DSMB.
3) AE rates and out of range data – AE rates will be evaluated quarterly and out of
range data will be evaluated yearly by the study PIs, Independent Monitor,
DSMB, and the institution’s pediatric medical investigator, Dr. Hsia, to ensure
proper AE reporting and to regulate procedures to protect participant safety.
C. Stopping Rules – This study may be stopped prior to its completion if: (1) adverse 
events that significantly impact the risk-benefit ratio have been observed; (2) study 
recruitment or retention becomes futile; (3) any new information becomes available 
during the trial that necessitates stopping the trial; and (4) other situations occur that 
might warrant stopping the trial. The PIs will include assessments of AEs and 
recruitment futility in the annual progress report to NIH to monitor these variables. 
The PIs will consult with the statistician if necessary to assess the impact of 
significant data loss due to problems in recruitment, retention, or data collection. 
D. Designation of an Independent Monitor – Mandy Shipp, Director of Clinical 
Regulatory Affairs at Pennington Biomedical, has been designated as the 
independent monitor for this study. Ms. Shipp has worked at Pennington Biomedical 
for over 14 years. She has served on numerous Data and Safety Monitoring Boards 
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and has served as the Safety Officer. She is not in either PI’s chain of command and 
is not involved with the study. 
E. Safety Review Plan – Study progress and safety will be reviewed monthly (and more 
frequently if needed). Progress reports, including patient recruitment, 
retention/attrition, and AEs will be provided to the Independent Monitor and reviewed 
quarterly, as outlined above. An annual report will be compiled and will include a list 
and summarization of adverse events. In addition, the annual report will address (1) 
whether adverse event rates are consistent with pre-study assumptions; (2) reason 
for dropouts from the study; (3) whether all participants met entry criteria; (4) 
whether continuation of the study is justified on the basis that additional data are 
needed to accomplish the stated aims of the study; and (5) conditions whereby the 
study might be terminated prematurely. The annual report will be signed by the study 
PIs and Independent Monitor and will be forwarded to the DSMB, PBRC IRB, and 
NIH to review the progress of this study on an annual basis. 
This study does not involve more than minimal risk to participants. Survey items 
about the child (to be completed by the parent) do not contain sensitive items to ensure 
individuals are comfortable responding. During individual measurements, the study staff 
will ensure full privacy of participants by taking measurements in a private or semi-
private area (ex: a separate room) with only the participant and researcher present. The 
parent will be notified of any significant health problems that are brought to our attention 
and participants will be referred to the participant’s usual source of medical care. 
Data will be stored in a secured area and all study staff must be HIPAA certified. 
Following transcription of the TGMD-3, all recordings will be de-identified and original 
audio/video tapes that contain names and images will be destroyed, to occur no later 
than 5 years after the study ends. Only pertinent study staff will have access to study 
data.
Withdrawal of Subjects
Participation is voluntary, so participants may withdraw from the study at any time. 
Data that have already been collected during the course of study participation from a 
withdrawn participant will be used, unless a specific request is otherwise received. 
Participants may be withdrawn from the study for the following reasons:

Unwillingness on behalf of the parent/child to participate in the study or 
cooperate with study staff
Risks to Subjects
We have found there is no more risk to the fundamental motor skill assessments 
than during typical play time.  There are no foreseeable risks or discomforts with the 
anthropometric measurements.  In the unlikely event that a child experiences an injury, 
the assessments will be discontinued.  Participants may find the accelerometer 
uncomfortable or bothersome to wear; however; the accelerometer is small, light, and 
comes with an adjustable strap to make the device as comfortable and unobtrusive as 
possible. 
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Potential Benefits to Subjects
Participants may experience changes in physical activity levels while using the 
PLAY app. Benefits of participating in this study should outweigh the risks for all 
participants in this study.
Vulnerable Populations
This study will involve young children as participants (3-5 year olds). As such, the 
parent/legally authorized representative will provide written informed consent allowing 
the child to participate in individual study procedures. Due to the young age and lack of 
cognitive/decision-making capacities of this age group, participants will not be asked to 
provide documented assent; however, all procedures will be explained in child-friendly 
terms and a child’s refusal to participate will be respected by study staff. 
All participants will be explicitly told that their participation is voluntary and that 
they may terminate their participation at any time. If a participant indicates that they 
wish to stop participating, all study procedures they are undertaking at that time will be 
stopped to protect their rights and welfare.
Sharing of Results with Subjects
Study results will not be shared with participants unless requested. If requested, 
individual results may be made available.
Setting
All study procedures involving children will be conducted at local YMCAs or other 
community venues. Parents will utilize the PLAY app on their smartphone or tablet in 
their homes or other settings during free-living conditions. 
Resources Available
The project team for this single-site study is fully equipped to execute the 
proposed project with expertise in exercise, psychology/behavior change, pediatrics, 
and biostatistics. The team has extensive experience conducting pediatric and family-
based physical activity promotion research. 
Amanda Staiano, Ph.D. (mPI) is Assistant Professor and Director of the Pediatric 
Obesity and Health Behavior Laboratory. She is a developmental psychologist who 
contributes experience in designing and implementing family-based weight 
management interventions, including RCTs and prospective cohort studies of over 1500 
children and adolescents (e.g. NIH U54 MD 008602-P02UAB, USDA 3092-51000-056-
04A, AHA 15GRNT24480070). As mPI, Dr. Staiano will be fully responsible for the day-
to-day management of the project, she will manage enrollment, retention, and fidelity to 
the intervention protocol, and she will supervise progress towards meeting the project’s 
timeline. 
E. Kipling Webster, Ph. D. (mPI) is an Assistant Professor at Louisiana State 
University within the School of Kinesiology. Dr. Webster will manage the fundamental 
motor assessments, she will create the instructional content and fundamental motor skill 
videos for the app-based intervention, and she will supervise progress towards meeting 
the project’s timeline. 
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Robert Newton, Ph.D. (Co-I) is Associate Professor and Director of the Physical 
Activity and Ethnic Minority Health Laboratory. He has considerable experience in 
developing physical activity promotion interventions for children and will oversee the 
recruitment and retention of ethnic minority adolescents and provide his expertise to this 
project by utilizing mHealth technologies, developing behavioral physical activity 
promotion strategies and developing physical activity curriculum for children and 
families. 
Robbie Beyl, Ph.D. (Co-I) is Assistant Professor in Biostatistics. Dr. Beyl designed the 
statistical analyses and power analyses. As a faculty member of the Biostatistics Core 
at Pennington Biomedical, Dr. Beyl will provide guidance to the Principal Investigator for 
the randomization schedule and data management, analysis, and interpretation.
The Project Manager will provide coordination and oversight of the clinical project 
including study start-up and IRB regulatory submissions, the creation and testing of 
manuals of procedures, weekly study meetings to monitor progress in recruitment, 
enrollment, and data collection at assessment visits and during the intervention. The 
Project Manager will also provide leadership for intervention staff and will serve as a 
liaison between the investigators and the data collectors and study staff to help ensure 
that project milestones are met.
Drs. Staiano and Webster will consult with each other and build consensus on 
administrative and scientific decisions that must be made during planning and execution 
of the protocol. During the proposed project, Drs. Staiano and Webster will hold a 
weekly meeting with the study team, which will be led by Dr. Staiano. Further, Drs. 
Staiano and Webster will meet alone and occasionally with the Project Manager no less 
than once every two weeks to review the study status and address administrative tasks. 
Additional consults will occur on an “as needed” basis. Finally, Dr. Staiano will meet with 
the intervention team once per week to facilitate treatment fidelity, and Dr. Webster will 
meet with the data assessment team biweekly to ensure protocol fidelity. 
Prior Approvals
The YMCA administrative staff will be required to provide written approval to 
allow the conduct of study procedures at their site.
Compensation
Subjects will be compensated up to $75 for participation, provided in increments 
of $25 (upon the completion of the Baseline Visit [Week 0], the End of Treatment Visit 
[Week 12], and the Follow-up Visit [Week 24]). 
Compensation for Research-Related Injury
No form of compensation for medical treatment or for other damages (i.e., lost 
wages, time lost from work, etc.) will be available for this research study. In the event of 
injury or medical illness resulting from the research procedures, participants will be 
referred to a treatment facility.
Economic Burden to Subjects
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Participants and participating families will be required to bear the cost of 
transportation to and from all study visits.
Consent Process
Informed consent will be obtained prior to conducting any study procedures. 
Because there is not a greater than minimal risk, informed consent will be obtained from 
one parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child. The study 
procedures will be explained to parent(s) and prospective participants (3-5 years of 
age). The parent/legally authorized representative and prospective participant will be 
asked if they have any questions about the study. The parent/legally authorized 
representative and prospective participant will be offered a waiting period between 
informing the prospective participant and obtaining the consent. When the parent/legally 
authorized representative and prospective participant are both ready, the informed 
consent process will then proceed as follows:

Parent/legally authorized representative will be given an informed consent 
form to read and sign indicating their permission to allow their child to 
participate in the study.
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