Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare
Phase: NA
Conditions: Obesity
Sponsor: University of Arkansas

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 1 
University of Arkansas for Medical Sciences (UAMS) Clinical Protocol 
 
Study Title: 
Developing and Testing Implementation Strategies for 
Evidence-Based Obesity Prevention in Childcare 
 
Principal Investigator:  
Taren Swindle, PhD 
University of Arkansas for Medical Sciences 
521 Jack Stephens Drive, Slot # 531 
Little Rock, AR 72205 
Telephone:  870-236-0997 
Email:  tswindle@uams.edu 
 
Study location: 
University of Arkansas for Medical Sciences 
 
Support (Funding): 
NIDDK K01; COBRE Pilot; Arkansas Biosciences Institute  
 
 
 
 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 2 
Table of Contents 
 
Table of Contents ............................................................................................................ 2 
Abstract ........................................................................................................................... 3 
Background and Rationale .............................................................................................. 3 
Objectives ....................................................................................................................... 5 
Study Design and Procedures ......................................................................................... 6 
Study Population, Inclusion, and Exclusion ................................................................... 10 
Risks and Benefits......................................................................................................... 11 
Data Handling and Recordkeeping................................................................................ 12 
Data Analysis ................................................................................................................ 12 
Ethical Considerations ................................................................................................... 14 
Dissemination of Data ................................................................................................... 15 
References .................................................................................................................... 16 
 
 
 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 3 
Abstract 
The proposed research plan has three specific aims: 
(1) Identify factors associated with degree of fidelity in a previously developed and 
tested basic implementation strategy of WISE; 
(2) Develop an enhanced implementation strategy to support uptake of the WISE 
intervention using stakeholder input; and  
(3) Pilot test the enhanced implementation strategy on implementation and child 
health outcomes using formative evaluation. 
To execute these aims, we will use innovative methodologies including an explanatory 
mixed methods approach (Aim 1), a stakeholder-driven Evidence-Based Quality 
Improvement (EBQI) process (Aim 2), and a Hybrid Type 3 implementation design using 
formative evaluation (Aim 3).  We expect that implementation strategies developed with 
stakeholders will lead to improved implementation fidelity.  We will test the hypothesis 
that improved WISE fidelity is positively related to child outcomes (e.g., child fruit and 
vegetable intake, BMI).  This research will provide critical knowledge on the value of 
investments in implementation support strategies to existing obesity prevention 
interventions. 
Background and Rationale 
Overweight and obese children are at 5-times greater risk for developing diabetes and 
at 3-times greater risk for hypertension and high triglycerides in adulthood.4  Concurrent 
health issues include asthma, metabolic risks, depression, and attention deficit 
hyperactivity disorder.5,6  In spite of some recent progress, the prevalence of childhood 
obesity is still alarming, particularly for children of lower socioeconomic status.7  For 
example, 14.2% of 2 to 4 year olds in low-income families in Arkansas (AR) are obese 
which is higher than the national average for this age range.8  Further, recent data show 
that Arkansas has the highest adult obesity rate in the nation (35.9%).9  Prevention 
efforts in this high-risk area are clearly warranted. 
Given that families impacted by poverty often access subsidized childcare, childcare 
provides a critical setting to address socioeconomic disparities in obesity.  Children may 
eat over half of their dietary intake in this setting, up to 540 meals and snacks per 
school year.10  This is notable because young children’s eating habits are more 
attributable to environmental factors than genetics.11  The overarching goal of this study 
is to apply principles of Implementation Science (e.g., formative evaluation, enhanced 
facilitation) to support the uptake and sustainability of an evidence-based interventions 
(EBIs) for obesity prevention and nutrition promotion in childcare. 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 4 
Previous investigators have recognized the potential for educational settings to impact 
children’s diets and prevent obesity.  A recent study by AR Co-Investigators found that 
regular exposure to fruits and vegetables during school snacks was associated with a 
3% reduction in obesity among children in low-income school districts.12  Additionally, 
nutrition interventions in childcare have been associated with increased willingness to 
try and liking of new foods.13  These types of early interventions are key as food habits 
and preferences established in early childhood persist across the lifespan.14 
Despite the potential to reach at-risk children in childcare, current practices are not 
consistent with evidence-based obesity prevention. 15  A review of 18 studies in 
childcare settings found that Early Childhood Educators (ECEs) often do not follow 
evidence-based practices, including signaling hunger cues, avoiding the use of foods for 
celebration/reward, and allowing children to decide how much to each without 
pressure.15  Personal characteristics of ECEs may be associated with negative 
practices. For example, education level and/or race/ethnicity have been associated with 
pressuring children to finish their food before leaving the table,21 eating less with 
children, and restrictive feeding practices (e.g., offer food for good behavior).22  At the 
organizational level, a review of state childcare regulations found that agencies vary 
considerably in their efforts to prevent childhood obesity.23  AR had policy standards 
related to only 1 of 8 known best practices.  Programs without supportive policy are less 
likely to use best practices.22,24  This evidence suggests that ECEs and childcare 
centers need additional implementation support for evidence-based obesity prevention. 
Implementation Science provides a needed lens to address the gap between the 
evidence base and actual practice of obesity prevention in childcare.  Implementation 
Science is the study of how best to support uptake and sustainability evidence-based 
best practices.1  Return on investment for implementation research is much greater than 
that for basic science27 and allows for increased reach and adoption of scientific 
knowledge.28  For example, improvements in fidelity were associated with greater gains 
in indicators of emotional well-being in an implementation trial of a curriculum for 7 to 8-
year- old children in disadvantaged schools.29  Implementation strategies in schools 
such as consultation, performance feedback, and coaching have been linked with 
improved outcomes.30-32 
However, Implementation Science around obesity prevention in childcare is limited.  A 
2010 systematic review identified no trials investigating implementation strategies’ 
impact on the uptake of evidence-based obesity prevention in childcare.33  A recent 
review identified one Australian trial which found implementation strategies (i.e., 
incentives, training, monitoring and feedback) to positively impact organization-level 
measures of dietary best practices, e.g., increasing offerings of water and 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 5 
fruit/vegetables.34  Another Australian study is underway testing the impact of executive 
support, consensus processes, training, and monitoring/feedback on the adoption of 
nutrition policies.35 
A primary goal of this study is to improve use of evidence-based obesity prevention in 
childcare through development of effective implementation strategies.  We will enhance 
knowledge of how to improve implementation, fidelity, and sustainability in these under-
studied locations.  Childcare shares some contextual similarities with other locations 
where implementation research has taken place (e.g., schools and other contexts where 
“paraprofessionals” provide health-related services); however, we don’t know whether 
lessons learned apply to childcare.  Ultimately, improvements in evidence-based obesity 
prevention in childcare have the ability to impact 11 million children under age 5 in the 
US annually.36  It is therefore imperative that we develop and test strategies to 
maximize implementation and sustainability of these practices. 
Objectives 
This proposal proposes the following aims:  
Specific Aim 1.  Identify factors associated with degree of fidelity in a previously 
developed and tested basic implementation strategy of WISE.  An explanatory 
mixed methods approach will use secondary data to identify positive deviance and 
implementation failures among ECEs in a previous WISE implementation study that 
observed notable variability in fidelity to best practices for obesity prevention.  ECEs 
from the prior study will be identified from quantitative fidelity observations and invited to 
participate in qualitative interviews to determine contextual and individual barriers and 
facilitators to effective implementation. 
Specific Aim 2. Develop an enhanced implementation strategy to support uptake 
of the WISE intervention using stakeholder input.  Based on results from Aim 1, an 
Evidence-Based Quality Improvement (EBQI) process18 will be used to engage 
stakeholders to develop implementation support strategies consistent with an 
implementation framework (i-PARiHS) and matched to identified barriers/ facilitators.  
Specific Aim 3.  Pilot test the impact of the enhanced implementation strategy on 
implementation and child health outcomes using continuous formative 
evaluation.  We will determine whether the enhanced strategy is feasible, acceptable, 
and demonstrates improved implementation, fidelity, and sustainability using a Hybrid 
Type 3 implementation design.1  Further, we will test the hypothesis that better WISE 
fidelity is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI). 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 6 
Study Design and Procedures 
Aim 1.  We will use an explanatory sequential mixed methods design to understand 
barriers and facilitators specific to WISE implementation (quant→QUAL).  Quantitative 
data gathered from monthly fidelity observations in previous implementations of WISE 
(i.e., quant) will be used to identify positive deviants and implementation failures for 
semi-structured interviews (i.e. QUAL).  Concepts from the i-PARiHS framework will 
inform the interview guide.  For example, we will ask educators about perceptions of the 
evidence-based practices that comprise WISE that impede or promote use of the 
innovation.  We will also ask about contextual elements (e.g., values, organizational 
culture) that made the implementation of WISE easier or more difficult. Previous WISE 
educators (N = 44) with complete observational data will constitute the sample pool for 
semi-structured interviews.  We will also interview directors from each of the 7 sites in 
previous WISE implementation to provide a multi-stakeholder perspective and expose 
potential organizational barriers and facilitators. 
Aim 2.  We will use EBQI to (1) match barriers and facilitators to WISE implementation 
with potential strategies, (2) tailor strategies to the early childhood context, and (3) 
finalize the enhanced implementation strategy for WISE.  The EBQI Panel will include 
teachers and directors from representative sites that will implement the enhanced 
strategy in Aim 3.  We will include at least one teacher from previous WISE 
implementation to have an expert advisor role, providing feedback on feasibility and 
acceptability of potential enhanced implementation interventions based on prior 
experiences.  We will also recruit parents to inform (a) potential improvements to 
enhance the link between the classroom and home and (b) strategies to improve 
assessment of impacts on WISE for future studies (e.g., parent recruitment strategies, 
collection of genetic/ biological data for possible future moderator/mediator analyses). 
We expect to recruit an EBQI panel of 10 stakeholders.  The EBQI panel will review the 
data on the evidence-based practices, examine the data collected in Aim 1, and outline 
suggested implementation strategies.  The group will work until we have a mutually 
agreed-upon, locally-adapted (if necessary) WISE intervention and a set of 
implementation interventions/tools (our “enhanced” implementation strategy) with 
accompanying steps on how to deploy them.  
We will employ strategies to provide structure to the EBQI process.  For example, a 
concept mapping approach invites stakeholders to rate proposed strategies in regards 
to their importance and feasibility on a Likert scale (1=not important/feasible, 5 = 
extremely important/feasible).  This approach provides quantifiable information, 
promotes efficient collection of input, and provides a basis from which to probe the 
EBQI panel.  Meetings are anticipated to last 1-2 hours.  We will audio record the 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 7 
meetings to facilitate later review. Participants will receive $50 for service at each of the  
8 sessions of the panel. 
Aim 3.  We will use a Type 3 Hybrid Design to test the effectiveness of the enhanced 
implementation strategy (i.e., facilitation) on uptake while also assessing impacts of the 
intervention on child outcomes.  We expect that the effectiveness of WISE on child 
outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows 
for us to explore this hypothesis (in a preliminary fashion in the proposed pilot study, but 
in a definitive fashion in the subsequent R01).  
RE-AIM provides an 
evaluation framework to 
assess key aspects of 
intervention programs 
implemented in real-word 
settings.  See Table 1 for a 
summary of outcome 
measures that align with RE-
AIM.  Reach will be reflected 
by teacher report of the 
number of realized 
opportunities for WISE lessons 
divided by the number of 
possible opportunities (target 
= 4 opportunities per child per 
month).  Adoption will be 
measured using teacher reports of the number of WISE handouts distributed (target = 2 
per child per month), teacher report of the number of WISE lessons and activities 
presented each month, and assessment of food purchase records to assess frequency 
of purchase of WISE foods.  Further, we will modify and use The Organizational 
Readiness to Change Assessment (ORCA)85 as developed for use with the i-PARiHS 
framework to assesses change commitment (e.g., We value this change) and change 
efficacy (e.g., We can keep the momentum going) both prior to and during 
implementation.  For Implementation, our WISE fidelity measure will be used across the 
school year. The WISE fidelity instrument (See WISE fidelity) is rated on a 1 to 4 scale 
with 4 representing the highest level of fidelity. Each core component is assessed with 2 
items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a 
component. Additionally, overall scores on the fidelity form are created by summing 
scores across items (range = 0 – 32). Inter-rater reliability of 85% will be ensured.  
Finally, acceptability and feasibility26 will be assessed through semi-structured 
Table 1. Outcome Measures for Hybrid Trial  
Construct 
Measures 
Reach  
Number of ECEs/students impacted 
Effectiveness 
Child FFQ; Child BMI; Child RRS scan 
Adoption 
Food purchase records reflecting the 
number of WISE lessons completed; 
ORCA 
Implementation  WISE fidelity, acceptability, feasibility 
Maintenance 
Number of teacher maintaining/ 
increasing in fidelity after 6 months 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 8 
interviews at two time points: (1) between the Fall and Winter and (2) Winter and Spring 
fidelity assessments. We will also conduct interviews with champions and directors at 
enhanced sites at the conclusion of the school year. These interviews will focus on 
identifying remaining barriers and facilitators to WISE uptake as well as assessing 
feasibility and acceptability of the implementation strategy (See Director and Champion 
Interview Guides).   Maintenance will be assessed by determining the proportion of 
teachers that increase or remain the same in adoption and fidelity from the initial 
assessment (Fall) across the school year (Winter and Spring). 
In addition to these measures collected through the K01 study, the COBRE 
project will support the addition of ECE Feeding Assessments at mealtimes and a 
baseline assessment of center climate and context. The K01 protocol only included 
support to assess fidelity to this core component at WISE lessons, not mealtimes. 
However, it is possible that ECEs’ adoption (or lack thereof) of positive feeding practices 
at mealtimes may impact the overall effect of WISE on child outcomes. We will add two 
assessments of ECE Feeding Practices: Table Talk79 and the Food Intake module of the 
Building Mealtime Environments and Relationships (BMER)80 inventory. Both measures 
are suited for live observations to record actual ECE behavior. Table Talk quantifies 
ECEs’ feeding communications and captures the full range of practices (i.e., not prone 
to ceiling effects). It captures feeding communications that are detrimental (e.g., 
comments that pressure children to eat more, hurry children to finish, coerce children to 
eat certain foods) and those that are evidence-based (e.g., direct to internal cues, 
support food exploration). The Food Intake module of BMER captures adult interactions 
that support or undermine self-regulation at meals (e.g., “Adults do not praise children 
for cleaning their plates.”).These baseline measures will be collected in the Spring of 
2018 across 4 months (Feb- May) (See Combined Mealtime Observation Forms). We 
will collect three assessments in each classroom to best account for potential variability 
due to time of year or the menu served. Prior to classroom observations, each teacher 
will be invited to complete a one page (front and back) survey about characteristics of 
her center (See Pre-WISE Context Measure). This information will be used to inform 
stratified randomization to treatment conditions (basic or enhanced).   
Secondary outcomes will include those related to impacts of the program on children 
(i.e., Effectiveness).  All families complete a Family Map Inventory (FMI)86 for fall and 
spring assessment of family strengths and needs. For this study, the FMI will include a 
Food Frequency Questionnaire to assess consumption of WISE foods.  BMI is a 
required twice-yearly, federal assessment for Head Start children.  An anonymous 
record review of these data will provide a comparison of impacts on child diet between 
the basic and enhanced implementation conditions.  Further, we will collect Resonance 
Raman Spectroscopy (RRS) scans from children with equipment leased from NuSkin. 
RRS is a promising alternative for measuring biomarkers where carotenoid levels are 
measured by an optical scan of the palm.87,88  Carotenoids (i.e., plant pigments) are 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 9 
phytochemicals that provide the bright colorings to vegetables.89  When ingested, 
carotenoids become biomarkers for dietary habits, evident in the makeup of cell tissues 
including the skin.90  RRS measurements are reflective of dietary intake over the 
previous four weeks.  RSS scans are sensitive to detecting individual differences of 
carotenoid levels91,92 and experimentally initiated changes.93,94  
An additional secondary outcome of interest is the cost required to deliver the enhanced 
implementation support. Through the EBQI process, we determined the enhanced 
condition sites will each have a site-level champion. This champion will be a local leader 
in WISE implementation. Champions will receive an additional 3 hours of training to 
equip them to serve in this role. Champions will be supported by external facilitators 
from the WISE staff. The facilitators will meet with each champion in person at least 
once per month. Related to estimating the costs of this strategy, facilitators will track 
their contacts with sites (See Facilitation Log). We will also request tracking of efforts by 
site champions. (See Champion Log). Finally, we will ask all teachers to report monthly 
on their use of lesson and enhanced support materials (See Teacher Material Report). 
Data will be collected either through a secure RedCap Server or using paper and pencil. 
Our partnering Head Start agency has 12 sites with 38 classrooms.  Classrooms will be 
randomized to participate in either the basic (i.e., control) or enhanced implementation 
of WISE.  Sites are all within Pulaski County and have a similar demographic make-up 
of ECEs and families.  All families served meet the federal guideline for poverty (e.g., an 
annual income of $24,250 for a family of 4). All ECEs will receive basic implementation 
supports (6-hour training at beginning of school year and monthly newsletter).  Those 
randomized to the enhanced condition will receive the additional package of 
implementation support strategies developed in Aim 2 on a schedule agreed upon by 
the EBQI panel (e.g., monthly).  These will be delivered by the PI or the research 
assistant.  For both groups, we will collect child data before and after implementation. 
This will provide us with a matched design to assess comparative effectiveness. For 
both groups, the 6-hour training will be conducted in collaboration with the USDA-
funded Team Nutrition project at UAMS (IRB # 206442). Their exempt training 
evaluation protocol will be in place. We will extract records from their database specific 
to our UAMS Head Start attendees, link with other study records, and then de-identify 
data using our coded ID system.  
Building on the Team Nutrition evaluation, we will also conduct surveys of teachers at 
the end of the school year in both treatment groups. These surveys will be a repeat 
assessment of measures included in the pre-training survey as well as addition of 
standardized measures of feasibility, appropriateness, and acceptability,95 
implementation leadership,96 Organizational Readiness for Implementing Change,97 the 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 10 
About Feeding Children assessment,98 and educator perceptions of the support they 
received.99 For the enhanced group, we will also include questions on their use of 
aspects of the implementation strategy. Teachers will have to complete these surveys 
outside of their work schedule. Therefore, we will pay a $25 incentive for every returned 
survey. The surveys are estimated to take 30 to 45 minutes. Given limited success with 
web-based surveys in this group, we will gather these surveys using paper and pencil.  
We will complete fidelity observations three times per year: Fall (Sept – Oct), Winter 
(Jan – Feb), and Spring (March- April). See WISE Fidelity Form.  We will train contract 
staff to conduct fidelity assessments using videos of previous WISE lessons and ensure 
85% reliability is achieved.  After the Fall and Winter assessments, we will determine 
which teachers are achieving fidelity.  We will randomly select 5 ECEs to complete 
semi-structured interviews with study staff on aspects of feasibility and acceptability of 
the implementation. We will restrict our interviews to ECEs that are not achieving fidelity 
if 5 are in that category. After analysis of these interviews at each of the two iteration 
points, we will hold EBQI meetings to review the themes that emerged and the 
observed fidelity in the classrooms up to that point.  With feedback from the EBQI panel, 
we will use this information to determine shifts needed to improve the enhanced 
strategy for the remainder of the school year. 
Study Population, Inclusion, and Exclusion 
Aim 1.  37 Head Start educators and directors will complete one-on-one, open-ended 
interviews.  The educators will be selected based on secondary data from WISE fidelity 
observations collected in a previous study.  These data were collected with consent of 
the educators.  Based on total fidelity scores, the top and bottom 15 educators will be 
invited to provide input on the barriers and facilitators to their success.  Directors from 
participating agency will be invited to provide their input on the same topic.  Once 
selected, educators will be contacted via their center’s phone number and invited to 
participate. We will provide information about the study over the phone, and educators 
will have the opportunity to schedule an interview.  Teachers will be provided an 
incentive of $25 for participation in the interviews. 
Aim 2.  In Aim 2, we will engage key community stakeholders to serve on our Evidence-
Based Quality Improvement (EBQI) panel and provide input on development of an 
enhanced implementation strategy for WISE.  This process will review the existing 
scientific evidence and data from Aim 1 with the EBQI panel to solicit stakeholder input 
on how best to support WISE implementation. We will recruit stakeholders from: 
(a) sites that will implement WISE in Aim 3,  

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 11 
(b) sites that have previously implemented WISE, and  
(c) parents served by Head Start. 
EBQI sessions will be audio recorded to allow for review of content covered in each 
session and to allow for rapid coding of the reactions of the EBQI panel.  These data will 
be collected anonymously.  Panel members may also be asked to complete survey 
instruments to provide quantitative input on proposed strategies.  The identity of EBQI 
members will not be included in reports or manuscripts.  Each panel member will 
receive $200 for service on the panel.  We expect to engage approximately 10 
stakeholders in the panel and to meet in person 6-8 times. 
Aim 3.  38 classrooms from our partnering Head Start agency will be randomized to 
implement the basic WISE strategy used in previous studies or the enhanced WISE 
strategy developed in Aim 2. Because the program is now adopting the WISE 
curriculum in all agency classrooms, WISE lessons are a part of normal educational 
activities. As such, we request a waiver of consent for these observations. In addition, 
10 educators will be randomly selected and invited to provide feedback on feasibility 
and acceptability through semi-structured, open-ended interviews twice during the 
school year. We are requesting waiver of consent for these interviews as they would be 
the only document identifying teachers as participants in interviews. We will collect 
verbal consent on our audio recording. Teachers, directors, and champions will be paid 
$25 for the interviews as they will take place outside of center hours.   
Additionally, to assess comparative impacts on children, we will record review Body 
Mass Index (BMI) and Food Frequency Questionnaire (FFQ) data from the agency 
records at the beginning and end of the school year.  We will collect a Resonance 
Raman Spectroscopy (RRS) assessment from children at the beginning and end of the 
school year as well. RRS is an optical scan of the hand to assess carotenoid intake 
from fruits and vegetables.  It has been used safely in prior studies with children aged 3 
and older.  We expect to collect this information from up to 820 children between the 
ages of 3 and 5. 
Risks and Benefits 
As in all research, there exists the potential risk to study participants is the potential for 
loss of confidentiality.  Measures to protect the confidentiality of study participants will 
be implemented as described in the Data Handling and Recordkeeping section below.  
No physical risks related to participation in this study are foreseen.  Some educators 
may experience discomfort as a result of answering questions that they consider 
personal in nature.  This risk will be minimized by their ability to withdraw from the study 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 12 
or to refuse to answer any question which makes them uncomfortable. 
There may be some indirect benefit to participants taking part in this study.  As we learn 
more about implementation of obesity prevention and nutrition programs in childcare, 
better training opportunities and support for teachers may become available. In turn, this 
could result in improved services for children and families.  It is also possible that 
participants will experience no direct benefit as a result of participation. 
Data Handling and Recordkeeping 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study.  All study subject 
material Information obtained will be summarized without identification.  Participants will 
have no identifying information linked with their responses.  Study documentation will be 
kept in a locked file in the principal investigator’s office, if hardcopy, or on a password-
protected UAMS server, both located behind locked doors in a restricted access area of 
the UAMS campus.  Only those individuals listed on the title page of this protocol will 
have access to the code and information that identifies the subject in this study. 
Data Analysis 
Aim 1.  We will create a total fidelity score for teachers who participated in WISE 
development.  This score will be a sum of the number of WISE components where 
fidelity was observed across observations (Possible range = 0 – 32; 4 components * 8 
observations).  These scores will be used to inform purposive sampling for semi-
structured interviews.  ECEs with the highest fidelity and lowest fidelity scores will be 
interviewed.  We expect to interview 7 directors and 15 ECEs from each group (N=37).  
Interviews will last 30-60 minutes and be transcribed verbatim.  Nvivo software will 
facilitate a shared workspace for the team and aid in organization of coded text. 
Transcripts will be coded using directed content analysis.  The i-PARiHS framework will 
provide sensitizing concepts to build initial codes.  Codes will be used to succinctly label 
significant, recurrent ideas across participants.  Primary and secondary coders will code 
the same 2 manuscripts.  At weekly meetings, the coding pairs will resolve 
disagreements and expand the codebook.  Kappa of 0.8 will be required for coders to 
code independently with ongoing collaboration to refine codes. 
Aim 2.  With additional research support through a COBRE pilot project, we will be 
able to process the data from the concept mapping ratings in real time. That is, panel 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 13 
members will rate proposed strategies on electronic devices (e.g., i-Pads) which will 
submit information to a data capture system (i.e., Teleform) which can then produce a 
plot of potential strategies on 
their rated importance (x-axis) 
and feasibility (y-axis). 
Figure 2 provides an 
example Go-Zone plot from 
published concept mapping 
work by Waltz and 
colleagues.6 Strategies in 
Quadrant I represent those 
that are above the mean for 
both importance and feasibility 
and thus represent the 
greatest consensus for 
implementation strategies to 
target. Our plots will include far fewer ratings, likely between 10 and 20 per meeting. 
This improvement in data processing will allow for in-depth discussion and 
operationalization of strategies in the same meeting in which the strategies are initially 
rated. Without the added support from this pilot project, the research team would be 
processing data between EBQI meetings. Thus, the data automation supported by this 
pilot project will streamline the process and prevent long gaps (1-2 months) between 
when the EBQI panel provides the ratings and when they next discuss those rated most 
highly.  
After each EBQI meeting, the research team will work to assimilate the input from the 
EBQI panel, translate it to actionable plans, and develop the next iteration of materials 
for which we seek to receive panel input. For the qualitative information collected from 
notes and audio recordings, we will employ rapid qualitative coding relative to the main 
goals of this EBQI process (e.g., matching barriers/facilitators with implementation 
strategies, tailoring strategies to ECE context). We will write memos for each EBQI 
meeting to inform the development of the enhanced strategy. 
Aim 3.  We will complete rapid coding of the semi-structured interviews with the 
selected ECEs at each iteration.  This coding will focus on identifying aspects of the 
implementation feasibility and acceptability.  Two coders will complete initial content 
analysis independently and come together to resolve any differences.  These data will 
be combined with the fidelity data collected and presented to the EBQI panel.  Changes 
or improvements to the enhanced strategy will be driven be these findings and the 
feedback from the EBQI panel. 
At the completion of the study, analyses of Implementation and Effectiveness data will 
examine the descriptive statistics and examine outliers. Multi-level models (MLM) will be 
Figure 2. Example of Go-Zone Concept Mapping Plot 6 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 14 
used to account for the dependence among repeated observations of the same 
teachers in the same classroom as well as children nested within classrooms. MLM 
refers to a class of statistical techniques developed to analyze multi-level data 
structures and appropriately model clustered designs. The models will include a fixed 
term for intervention (basic versus enhanced) and time. Random effects will be included 
for the correlation of children within classrooms and the correlation of observations 
within teacher. This analysis will allow for estimation of variance in child outcomes 
accounted for by implementation (i.e., level 2) effects.  
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and 
procedures.  This protocol and any amendments will be submitted and approved by the 
UAMS Institutional Review Board (IRB) to conduct the study. 
Waivers of informed consent and Health Insurance Portability and Accountability Act of 
1996 (HIPAA) authorization were approved for Aims 1 and 2 of the project as this 
research involves no more than minimal risk to the subjects; waivers will not adversely 
affect the rights and welfare of the subjects; and the research could not practicably be 
carried out with the waiver. For these aims, the only record linking the subject and the 
study would be the consent document making the principal risk a breach of 
confidentiality.   
Since the initial IRB submission, WISE has expanded from being a curriculum offered in 
some UAMS Head Start sites to being required by the agency in all sites and 
classrooms. As such, WISE is now a part of standard educational activities. Due to this 
shift, we are requesting a waiver of consent for teachers in Aim 3 of this project. As in 
Aims 1 and 2, this research involves no more than minimal risk to the subjects; and 
waivers will not adversely affect the rights and welfare of the subjects.  

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 15 
The Head Start teachers and staff will hand out packets to each parent at enrollment. 
This packet will contain the study information sheet along with the necessary paperwork 
the parent completes to participate in Head Start. The researchers believe that this is a 
good strategy for ensuring that each parent receives and reads the information sheet, 
as the packet is necessary information for participation in the Head Start program. The 
parent can return the signed form with the rest of the packet if he/she does not want 
his/her child to participate. We are therefore requesting a waiver of documentation of 
consent (e.g., "passive consent")for the child participant in Aim 3. The study is minimal 
risk, and involves no procedures for which written consent is normally required outside 
the research context.  
Dissemination of Data 
I will employ a multi-pronged strategy to ensure that findings from this research are 
disseminated to scientists and community stakeholders. These efforts will not contain 
any identifiable information that could be linked to a participant. 
Scientists.  I will disseminate these findings to scientists with interests in early childhood 
development and education as well as nutrition and obesity prevention. I will attend the 
premier conference in nutrition, child development, and implementation science. I will 
also submit findings for publication to leading journals in the field such as Early 
Childhood Research Quarterly, Child Development, Appetite, and Journal of Nutrition 
Education and Behavior.  I will also share abstracts and publications with academic 
listservs and professional social networking sites on which I am a member. 
Community Stakeholders.  Early educators are a primary stakeholder in the findings of 
this research as well as directors and principals at agencies and schools.  I will share 
back findings of all stages of the project to participants and partnering agencies.  I will 
also reach stakeholders through presentation at local conferences with an early 
education focus.  In addition to presentation at in-person sessions, I will prepare Fact 
Sheets highlighting key findings to distribute from the booth that our department hosts at 
this conference each year.  This will increase the reach of the dissemination beyond 
those that attend a presentation session.  I will also send a thank you letter to teachers 
involved in both the secondary data and primary data portions of this project which will 
summarize our findings and next steps. 
 
 

Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 16 
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Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
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Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
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Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
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Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 20 
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Study Title: 
Developing and Testing Implementation Strategies for Evidence-Based Obesity 
Prevention in Childcare 
PI: 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
NIH K01 DK110141-01, Arkansas Biosciences Institute (FUNDED) 
 
NIGMS COBRE Center for Childhood Obesity Prevention (FUNDED)  
Version #: 6 
 
IRB# 205335 
Date: 
03/19/2019 
Page 21 
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