Physical Activity and Screen-Time Regulations in Childcare Centers: Influence on Young Children's Health Behaviors (Pause & Play) - Aim 3
Conditions: Childhood Obesity
Sponsor: Pennington Biomedical Research Center

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Protocol Title: Physical Activity and Screen-Time Regulations in Childcare Centers: 
Influence on Young Children’s Health Behaviors (Pause & Play) – Aim 3
Academic PI Name: Amanda E. Staiano, PhD, MPP
Co-Investigator’s Name: Corby K. Martin, PhD; Andrew T. Allen, BA
Sponsor: Gulf States Health Policy Center (NIMHD)
Protocol Version Date: 5/31/2016
IRB Review History: Initial Submission
Objectives
A. Specific Aims
Reducing childhood obesity is identified as a top priority of the Mayor’s Health 
City Initiative (MHCI) of Baton Rouge, Louisiana, which is a non-profit organization that 
brings together key community stakeholders to promote healthy living and active 
lifestyles. Louisiana’s prevalence of obesity in preschoolers is 60% higher than the 
national average: 13.8% of preschoolers in the state are obese1 compared to 8.4% 
nationally.2 Obesity prevalence is particularly high among non-Hispanic black children.2 
Childhood obesity contributes to a higher risk of adult obesity, premature mortality, and 
comorbidities including diabetes, hypertension, ischemic heart disease, stroke, asthma, 
and polycystic ovary syndrome.3 Physical activity is a protective factor against childhood 
obesity,4 whereas sedentary behavior has emerged as a risk factor for obesity.5 Yet the 
majority of preschoolers do not meet nationally recommended guidelines for physical 
activity or sedentary behavior. Less than 10% of preschoolers obtain the recommended 
1 hour/day of moderate-to-vigorous physical activity.6,7 Despite recommendations of no 
more than 2 hours/day of screen-time,8 which is the most common sedentary activity 
among preschoolers,9 children view on average 4.1 hours of screen-time each day.10 
Childcare centers represent an opportunity to increase physical activity and 
reduce sedentary behavior in preschool-aged children, since over 80% of children 
spend some time in childcare settings by the age of 3 years.10 Indeed, almost 50% of 
the variation in preschool children’s physical activity occurs in childcare centers.11 Yet 
the majority of childcare centers are conducive to low levels of physical activity and high 
levels of screen-time: many centers schedule little time and do not create designated 
space for physical activity,12 and children spend on average 1.3 hours/day watching a 
screen in these centers.9 Non-Hispanic black children and children with obesity are 
most likely to have both low levels of physical activity and high levels of screen time,13 
indicating that this population is particularly important to target to improve health 
behaviors. 
Most states do not have strong regulations for physical activity or screen-time in 
childcare settings.14 Louisiana’s Department of Education (DOE) is implementing new 
regulations for children in childcare settings in 2015 to comply with national 
recommendations: 1) physical activity of at least 1 hour/day and 2) screen-time limited 
to 2 hours/day. The DOE is also providing extensive training and programmatic support 
to the centers. For the proposed project, the MHCI joins academic researchers at 
Pennington Biomedical to evaluate the implementation of these regulations and to 
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examine effects on children’s health behaviors. During this project, we will answer three 
major questions: 1) are the regulations being implemented as intended; 2) do the 
policies benefit the intended audience; and 3) what do stakeholders identify as the most 
important strategies to improve children’s health behaviors. The demographics of Baton 
Rouge provide an opportunity to examine these questions in a high risk population: 46% 
of city residents are non-Hispanic black and 28% of children under the age of 5 years 
live in households below the federal poverty level.15 
The aims of the project are:
Specific Aim 3: To establish community priorities for strategies to improve 
young children’s health behaviors based on focus groups of stakeholders in the 
greater Baton Rouge area.
Specific Aim 3 will be achieved through a series of taskforce and focus group 
meetings administered by the MHCI. Meetings will include monthly meetings of the 
MHCI advisory boards composed of community stakeholders and focus groups of 
childcare center directors and parents. Stakeholders will create dissemination and 
implementation plans to leverage the findings of the project. 
Through this academic-community partnership, we are taking advantage of a 
natural policy experiment to examine the childcare environment and children’s 
behaviors before and after implementation of a policy change. We will also facilitate 
conversations among stakeholders to create additional strategies to increase young 
children’s physical activity and decrease screen-time both in childcare centers and in 
other settings. The overall goal is to increase physical activity and reduce screen-time 
among preschoolers enrolled in childcare centers. If successful, we will disseminate 
findings throughout the Gulf States region as a model of how changing policies in 
childcare settings can improve children’s health behaviors and reduce childhood 
obesity.
Background
The Problem to Address: Obesity and Physical Inactivity in Preschool Children
The Gulf States of Louisiana, Mississippi, and Alabama each rank in the top ten 
for highest prevalence of childhood obesity, adult obesity, physical inactivity, type 2 
diabetes, and hypertension.16 In Louisiana, obesity affects 13.8% of children aged 3 to 5 
years1 and 29% of all children aged 2 to 17 years,17 which is substantially higher than 
the national prevalence.2 Obesity during childhood contributes to several serious 
comorbidities including diabetes, hypertension, ischemic heart disease, stroke, asthma, 
and polycystic ovary syndrome.3 Moreover, children with obesity are at higher risk for 
premature mortality.3 
Increased physical activity and decreased sedentary behavior are key 
recommendations to reduce the risk for obesity and related comorbidities.18 Low levels 
of physical activity and high levels of sedentary activity contribute to a variety of mental 
and physical health consequences during the preschool and early childhood years, 
including obesity, high blood pressure, behavioral problems, academic problems, 
irregular sleep, and feelings of sadness and boredom.9 Indeed, physical activity and 
screen-time together explain 65% of the variance in children’s body mass index (BMI) 
from age 3 to 7 years.19 However, children are not obtaining sufficient levels of physical 
activity and are spending too much time in sedentary pursuits. Nearly half of preschool-
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aged children do not meet the recommended 1 hour of moderate-to-vigorous physical 
activity (MVPA) each day.7 Screens are highly prevalent in children’s lives due to 
increased device availability and marketing efforts,20 and preschool children are 
estimated to spend between 1.5 and 7.0 hours each day in screen-time21,22 despite 
recommendations for 2 or fewer hours of daily screen-time.
Reducing childhood obesity is identified as a top priority of the Mayor’s Health 
City Initiative (MHCI) of Baton Rouge, which is a non-profit organization that brings 
together key stakeholders in the community to promote healthy living and active 
lifestyles. Pennington Biomedical has joined with the MHCI to lead a number of projects 
to establish the prevalence of obesity and health risk factors in the community, to 
evaluate simulated effects of policy changes on childhood obesity prevalence, and to 
coordinate medical, academic, and non-profit organizations to strategize ways to 
promote healthy behaviors among children and families. This proposal represents a 
step forward in the partnership between the MHCI and Pennington Biomedical to 
empirically test the effects of a health policy aimed at improving children’s health 
behaviors in childcare settings. Given the vast majority of preschool children attend 
childcare centers,10 implementing policies that promote physical activity in these centers 
may have direct, impactful health benefits for young children.
A Carrot and Stick Approach to Improve Community Policies
Over the past year, the Louisiana Department of Education (DOE) has been 
given authority of childcare center licensing in the state of Louisiana. A 2012 state 
legislative mandate seeks to create a unified early childhood system under the DOE. 
With this transition, all licensing requirements are being revised; early care and 
education programs are being organized under local childcare center networks; new 
standards are being implemented for all childcare center providers that accept public 
funds; and a quality rating system is being redeveloped. Specific to the proposed 
project, new licensing standards will affect children attending over 1,300 licensed 
childcare centers state-wide and include: 1) physical activity of at least 1 hour/day and 
2) screen-time prohibited for children younger than 2 years and limited to 2 hours/day 
for children over 2 years. Childcare centers in East Baton Rouge Parish must begin 
implementing changes by 2016 to renew their annual license. 
In addition to the mandated regulations, the DOE is also offering new training 
and programmatic opportunities to help childcare centers achieve the regulations. The 
DOE has engaged directly with childcare centers around the state by supporting the 
implementation of the Nutrition and Physical Activity Self-Assessment for Child Care 
(NAP SACC) intervention, which is funded by the state's Maternal and Child Health Title 
V Block Grant and 1305 funding. NAP SACC is a national evidence-based intervention 
to prevent and reduce childhood obesity.23 It is implemented in childcare centers and is 
designed to promote healthy weight development in preschool children by improving the 
nutritional quality of food served, amount and quality of physical activity, staff-child 
interactions, nutrition and physical activity policies and practices, and related 
environmental characteristics. Over 200 centers have participated in the program and 
have integrated practices that support healthy weight behaviors since NAP SACC 
began in Louisiana in 2010. The Louisiana DOE will train childcare center personnel in 
East Baton Rouge Parish on these new regulations in 2015-16, offering a natural 
opportunity to examine childcare centers before and after implementation of the new 
policy.
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Preliminary Data
Baton Rouge, which is part of the Lower Mississippi Delta (LMD), represents one 
of the most medically underserved, at-risk populations living in the U.S. The Louisiana 
LMD is characterized by high levels of poverty, food insecurity, obesity, and related 
diseases. Approximately 40% of the Louisiana LMD population is African American, and 
28% of residents live in poverty, compared to 12% at the national level.15 This grant 
proposal arose from an ongoing collaboration between MHCI Director Mr. Allen and 
academic researcher Dr. Staiano, based on a shared interest to improve the health 
behaviors of young children in the Baton Rouge area. As part of a national effort 
organized by the U.S. Conference of Mayors, the MHCI was launched in Baton Rouge 
in response to the growing obesity epidemic and its relationship to chronic diseases 
which may be prevented or lessened through regular exercise and healthy eating. 
Community PI Mr. Allen directs the efforts of MHCI, which is a 501(c)(3) non-profit 
organization and includes three Advisory Boards that bring together community 
stakeholders on a monthly basis. As an Assistant Professor at Pennington Biomedical, 
a world-renowned nutrition and obesity academic research center, Dr. Staiano serves 
on the academic advisory board of the MHCI. Additionally, a medical advisory board 
and a community advisory board bring together stakeholders from area hospitals, non-
profit organizations, and government agencies.
This partnership arose from several years of collaboration between Pennington 
Biomedical and local health organizations. From 2008-2012, Louisiana researchers and 
child health advocates, through the leadership of Pennington Biomedical, released an 
annual report card (Louisiana’s Report Card on Physical Activity & Health for Children 
and Youth25) that provided grades on indicators related to children’s physical activity 
and health. The Report Card is an advocacy tool targeting adult decision makers and is 
intended to increase awareness of the health concerns associated with physical 
inactivity, to highlight the growing problem of physical inactivity and obesity among 
children and youth in Louisiana, and to generate political will for policy and 
environmental reform. In the 2011 Report Card,26 rather than assign grades, the Report 
Card research advisory committee followed the model set by the Healthy People 
initiative27 and established specific targets to reach by the year 2020 for each of the 
report’s indicators. These targets were also released for public comment. The target set 
for childhood obesity was a 20% reduction from baseline levels to year 2020. In 2012, a 
committee composed of Pennington Biomedical researchers including Dr. Staiano, as 
well as the lead policy analyst for chronic disease outcomes within the Louisiana 
Department of Health and Hospitals, and the Louisiana Director for Advocacy and 
Government Relations for the American Heart Association, convened to determine 
whether the 2020 childhood obesity target was achievable and to make evidence-based 
recommendations about policy approaches that would make the biggest improvements 
for this indicator. Our team used the Prevention Impact Simulation Model (PRISM), a 
systems model capable of projecting changes in obesity prevalence overall and among 
children.28,29 Eight of the policy and environmental interventions considered within 
PRISM are interventions advocated for childhood obesity, and one of these eight 
focuses on physical activity in childcare centers. The PRISM model estimated that a 
childcare center policy to increase children’s physical activity and reduce screen-time to 
meet recommendations would reduce overall childhood obesity prevalence by 2% by 
the year 2020. Given the new 2015 DOE state regulations to require physical activity 
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and reduce screen-time in childcare centers, the MHCI’s prioritization of childhood 
obesity prevention, and the prior work by Pennington Biomedical and the MHCI, this 
academic-community partnership is primed to evaluate progress towards creating 
healthier childcare centers in the city of Baton Rouge. The proposed project allocates 
resources to both the MHCI and Pennington Biomedical, using a community-based 
participatory research approach to ensure findings will directly impact the local 
community.
Significance
We created a unique partnership between a community-based non-profit 
organization (the MHCI) and a world-renowned academic research institute (Pennington 
Biomedical) to examine the effects of a health policy change in childcare centers on 
children’s health behaviors. The timing is ideal to establish baseline values of the 
physical activity environment and behaviors of children, then to evaluate these 
environments and behaviors one year after the childcare centers receive training, 
programmatic support, and mandated regulations to achieve the new physical activity 
and screen-time regulations. Community stakeholders in the MHCI have identified 
childhood obesity prevention as a top priority, but the majority of parents fail to 
recognize obesity in preschool children,24 and many mistakenly think that obesity is not 
a health problem at this age. We seek a shift in the climate of the community to 
recognize that preschool is a critical opportunity to improve health behaviors in order to 
put children on a trajectory towards life-long healthy living.
Inclusion and Exclusion Criteria
Two to three focus groups of 8-10 parents and childcare directors will be conducted to 
elicit community priorities for strategies to improve young children’s health behaviors.
Inclusion Criteria: 

Either a director of a licensed childcare center in East Baton Rouge Parish OR a 
legal guardian and/or primary caretaker of a child aged 3 to 5 years who is 
enrolled in a licensed childcare center

Able to understand and speak English

Willing to be audio-taped during the focus group (for transcription purposes)
Exclusion Criteria: 

Being affiliated with 1 of the 10 childcare centers being assessed for Specific 
Aims 1 or 2, either as a director/teacher or as a parent of a student

Cognitive impairments that interfere with participation in a group discussion 
Number of Subjects and Subject Timeline
We plan to conduct 2-3 focus groups of 8-10 parents and childcare directors, for 
a total of 16-30 participants. Participation in the focus group part of the study will last 
approximately 1 day. We plan to conduct all focus groups between January 2016 and 
June 2017.
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Study Timeline
This study will last from July 1, 2016 until June 30, 2017. A proposed timeline of 
all study procedures is listed below:
Jul 2016
 Aug 
2016
Sep-Oct 
2016
Oct-Dec 
2016
Jan-Mar 
2017
Apr-Jun 
2017
Recruitment 
for focus 
groups
Focus group 
meetings
Focus group 
transcription 
and analysis
Focus group 
manuscript 
preparation
Recruitment Methods
Parents and childcare directors at EBR Parish childcare centers will receive 
information about the focus groups via email, mail, fax, phone, or in-person. Individuals 
who express interest in the focus groups will be further contacted by study staff for 
scheduling. Out of the pool of 192 DOE licensed childcare centers in EBR parish, we 
should not have a problem recruiting 16-30 parents/childcare directors. We aim to 
recruit all focus group participants between July 2016 and December 2016.
Procedures
Focus Groups. A group informed consent will be obtained when participants 
arrive at the focus group location prior to the start of the focus group discussion. 
Participants will complete a brief demographic questionnaire. Focus groups will be 
moderated by 1-2 study staff members and will be audio and video-taped to aid in later 
transcription. The moderator will lead the focus group discussion with a series of 
scripted, open-ended questions designed to facilitate focused discussion and optimize 
consistency across focus groups. Each focus group should last approximately 1.5 
hours. Participants will receive a $20 as compensation for their time. 
Consent Process
A script explaining all aspects of the focus group that are normally detailed in a 
consent document will be read to the group prior to the focus group discussion. The 
researcher reading the consent script will stress that focus group participation is 
voluntary and will be available to answer questions during this time. Subjects who do 
not wish to participate in the focus group will be asked to leave the room prior to the 
start of the focus group discussion. By staying in the room during the focus group, this 
will be the participants’ way of telling the researchers that he/she agrees to participate.
Primary Endpoints and Data Analysis Plan
Transcripts of the focus group discussions will be imported into NVivo software 
(Version 10, QSR, Victoria, Australia) to allow for thematic evaluation. The evaluation 
process will include the following: 1) generation of key words, phrases, and quotes 
coded as variable themes agreed upon by at least one other participant in the group 
and repeated independently in another focus group; 2) grouping of variables based on 
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unifying concepts and themes; and 3) review of the variable groupings to ensure 
consistency and relevance of proposed unifying concepts. Primary endpoints of the 
focus groups will be qualitative concepts, themes, and quotes of the childcare center 
directors and parent perspectives that may aid in developing new strategies to increase 
physical activity and reduce sedentary behavior in preschool children.
Power Analysis
Power is achieved in qualitative focus groups when data saturation occurs, i.e. 
when themes are agreed upon by at least two participants in the group and repeated 
independently in another focus group. The completion of 2-3 focus groups with 8-10 
individuals each should allow for the perception of themes.
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, tests for inter-rater reliability, and data analysis. All electronic data will be 
stored in the secure Pennington database, 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. Access to data files can be made only 
with permission of the Academic Principal Investigator. 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
This study does not involve more than minimal risk to participants. Focus group 
questions do not contain sensitive items to ensure participants are comfortable 
responding. Only first names will be used during the focus group discussion and only 
focus group participants and the 2 moderators will be present in the room during the 
focus group discussion. Data will be stored in a secured area and all study staff must be 
HIPAA certified. Following transcription of the focus group discussions, all transcripts 
will be de-identified and original audio/video tapes that contain names and images will 
be destroyed. 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. 
Withdrawn participants will not be able to be removed from group data that have already 
been collected, such as the focus group discussions. Participants may be withdrawn 
from the study for the following reasons:

Unwillingness on behalf of the participant to participate in the study or cooperate 
with study staff
Risks to Subjects
There are no foreseeable risks to participants in this study. The focus group 
discussions will not include any sensitive topics that could make participants 
uncomfortable.
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Potential Benefits to Subjects
We cannot promise any direct benefits to the participant from participating in the 
focus group discussion, although policy changes and directions identified in the focus 
group discussions may improve physical activity and screen-time behaviors for 
children/students of focus group participants.
Vulnerable Populations
This study does not involve vulnerable populations. 
Sharing of Results with Subjects
Study results will not be shared with participants unless requested. If requested, 
only group summary data will be available for the focus groups.
Setting
Focus groups will be held at a convenient community location or a meeting room 
inside Pennington Biomedical Research Center.
Resources Available
Amanda E. Staiano, Ph.D., M.P.P., Academic Principal Investigator, is Assistant 
Professor and Director of the Pediatric Obesity and Health Behavior Laboratory at 
Pennington Biomedical. Dr. Staiano is a developmental psychologist with expertise in 
epidemiological surveys of children’s screen-time and public policy related to children’s 
health.
Corby Martin, Ph.D., Academic Mentor, Associate Professor, is a licensed 
clinical psychologist with extensive experience conducting population-based cluster 
randomized trials, including an ongoing clinical trial to test a home-based obesity 
intervention for preschool children. As a senior faculty member, Dr. Martin will provide 
ongoing mentorship to Dr. Staiano.
Andrew T. Allen, B.A., Community Investigator, is the Director of the Mayor’s 
Healthy City Initiative and Community Outreach Coordinator for the Office of the Mayor-
President in the City of Baton Rouge.
Additional staff members, including a PBRC project coordinator, a PBRC 
research specialist, and policy student worker located at the Mayor-President’s Office 
will oversee data collection and conduct the focus groups.
Both principal investigators have extensive networks to childcare centers 
throughout the city. Staff members will spend at least 2 weeks in each childcare center 
at baseline and 1 year later to establish rapport for recruitment and data collection. 
There are currently 192 licensed childcare centers and 13 Head Start centers located in 
EBR Parish, so we do not envision difficulties recruiting 16-30 parents/childcare 
directors for focus group participation. 
Prior Approvals
None.
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 
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injury or medical illness resulting from the research procedures, participants will be 
referred to a treatment facility.
Economic Burden to Subjects and Compensation
Focus group participants will be responsible for bearing the cost of transportation 
to and from the focus group location. Focus groups will be held at a convenient 
community location to cut down on these costs and focus group participants will receive 
$20 in compensation upon focus group completion to offset these costs. 
Drugs or Devices
N/A
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30, 70-77.
Pennington Biomedical IRB FWA 00006218
Approved 06/01/2016