A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Phase: NA
Conditions: Obesity
Sponsor: University of North Carolina, Chapel Hill

 
 
A Hybrid Effectiveness-Implementation Trial of Go NAPSACC: A 
Childcare-Based Obesity Prevention Program 
 
NCT number NCT03938103 
Document Date 01/24/2024 
 

PROTOCOL TEMPLATE: INTERVENTIONAL STUDY 
 
Complete Title: A hybrid effectiveness-implementation trial of Go NAPSACC: a childcare-based obesity 
prevention program  
 
 
 
Short Title: Evaluation of an Enhanced Delivery Model for Go NAPSACC 
Drug or Device Name(s): N/A 
FDA IND/IDE (if applicable): N/A 
Sponsor: NIH NHLBI 
Protocol Date: 01/10/2024 
 
National Institutes of Health 
National Heart, Lung, and Blood Institute 
31 Center Dr 
P.O. Box 30105 
Bethesda, MD 20824-0105 
United States 
Derek Hales  
1700 Martin Luther King Jr Blvd 
CB#7426 
Chapel Hill, NC, 27599-7426 
Phone 919-966-8598 
email: derekh@email.unc.edu 
 
PROTOCOL TITLE:  
A hybrid effectiveness-implementation trial of Go NAPSACC: a childcare-based 
obesity prevention program  
Short Title:  
Evaluation of an Enhanced Delivery Model for Go NAPSACC 
Lead Investigator: 
Derek Hales, PhD. 
 University of North Carolina at Chapel Hill 
Protocol Version: 1.0  
Version Date: January 10, 2024 
 
I confirm that I have read this protocol and understand it.    
Principal Investigator Name:  
 
Derek  Hales 
 
 
Principal Investigator Signature: 
  
Date:   
 
 
 
1/24/24 
 

Table of Contents 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................................................ ……………3 
PROTOCOL SYNOPSIS .......................................................................................................................................................................................... 4 
BACKGROUND AND RATIONALE ......................................................................................................................................................................... 7 
1 
STUDY OBJECTIVES .......................................................................................................................................................................... 10 
2 
INVESTIGATIONAL PLAN ................................................................................................................................................................. 10 
3 
STUDY PROCEDURES ....................................................................................................................................................................... 11 
4 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................................................................ 14 
5               STATISTICAL CONSIDERATIONS ...................................................................................................................................................... 16 
6 
STUDY INTERVENTION (DEVICE, DRUG, OR OTHER INTERVENTION) ............................................................................................ 17 
7               STUDY INTERVENTION ADMINISTRATION (IF APPLICABLE) ........................................................................................................... 17 
8           SAFETY MANAGEMENT ................................................................................................................................................................... 17 
9           DATA COLLECTION AND MANAGEMENT ........................................................................................................................................ 18 
10           RECRUITMENT STRATEGY ................................................................................................................................................................ 18 
11           CONSENT PROCESS .......................................................................................................................................................................... 18 
12           PLANS FOR PUBLICATION ................................................................................................................................................................ 19 
13           REFERENCES ..................................................................................................................................................................................... 19 
APPENDIX .................................................................................................................................................................... 20 
 
 

Abbreviations and Definitions of Terms 
 
Abbreviation 
Definition 
EPAO-SR 
Environment and Policy Assessment and Observation- Self Report 
KY 
Kentucky 
PA 
Physical Activity 
TA 
Technical Assistant 
UNC 
University of North Carolina 
UKY 
University of Kentucky 
CFIR 
Consolidated Framework for Implementation Research 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL SYNOPSIS 
Study Title 
A hybrid effectiveness-implementation trial of Go NAPSACC: a childcare-based obesity prevention 
program  
Funder 
NIH NHLBI 
Clinical Phase 
Not Applicable 
Study Rationale 
• 
Child care is a crucial setting for obesity prevention initiatives given environmental 
influences on eating, and physical activity and the number of US children in some form of 
child care (12 million; 6 million in center based-program).  
• 
National authorities (e.g., Institute of Medicine, American Academy of Pediatrics) and 
Federal programs (e.g., Child and Adult Care Food Program) recommend that child care 
programs serve healthy foods, provide adequate time for active play, limit screen time, 
provide healthy role models, and educate children about healthy lifestyle choices.  
• 
Implementation studies are a critical next step in identifying effective approaches for 
child care-based health promotion and obesity prevention. But existing studies offer little 
insight into scaling up and implementing these evidence-based practices in child care.  
• 
The NAPSACC program is a notable exception, offering a structured process that helps 
child care programs adopt and implement best practices for obesity prevention. “Go 
NAPSACC” was created to translate core elements into user-friendly and interactive 
online tools that child care programs can use independently.  
• 
While pilot studies suggest that Go NAPSACC retains its effectiveness in improving their 
practices, further study is needed to confirm its effectiveness and examine strategies to 
enhance its implementation. 
Study Objective(s) This study will evaluate the impact of Go NAPSACC on child care center practices as well as the 
adoption, implementation, and maintenance achieved with Go NAPSACC when using basic vs. 
enhanced implementation models. 
• 
Primary Aim: Aim 1. Compare Basic vs. Enhanced Go NAPSACC’s impact on centers’ 
implementation of healthy weight practices. 
• 
Secondary Aims: Aim 2. Evaluate adoption, implementation, and maintenance of Go 
NAPSACC; Aim 3. Examine how organizational factors predict implementation; Aim 4. 
Calculate incremental cost-effectiveness ratio in terms of environmental change; Aim 5. 
Compare impact on children’s diet quality and physical activity at child care. 
Test Article(s) 
(If Applicable) 
TA Coaches are randomized to provide Basic Go NAPSACC or Enhanced Go NAPSACC delivery to 
their enrolled centers.   
In Basic Go NAPSACC (general prescription) TA Coaches will:  
• 
invite their centers to register, complete self-assessments, and create action plans 
• 
encourage centers to complete 2 cycles of Go NAPSACC’s 5-step improvement process 
• 
check in monthly to evaluate progress, provide suggestions, and trouble shoot issues. 
In Enhanced Go NAPSACC TA Coaches will:  
• 
Help center create an implementation team, conduct a readiness assessment, and guide 
choice of a priority challenge for each center.  
• 
Invite centers to register and complete self-assessments. 
• 
Help director create an implementation plan for the improvement process. This plan will 
be tailored based on the priority challenge identified from readiness assessment.  
• 
Check in monthly to evaluate progress, provide suggestions, and trouble shoot issues. 
• 
Facilitate quarterly cross-center meetings to create community and discuss issues.  
• 
Participate in a group check-in with a Go NAPSACC advisor (UNC research team) monthly 
and talk with UNC team individually each quarter. 

Page 5 of 20 
 
Study Design 
 
This is a type 3 hybrid effectiveness-implementation RCT with a clustered parallel group 
intervention design. TA coaches were randomized to deliver Basic Go NAPSACC or Enhanced Go 
NAPSACC to their enrolled centers.  
Subject Population 
Key criteria for 
Inclusion and 
Exclusion: 
For this study we will recruit Technical Assistants (TA Coaches) and child care centers. From each 
center, we will recruit and enroll a director and 2 teachers.  
TA Coaches  
• 
Must either be Quality coach or a Healthy and Safety coach 
• 
Must be able to read and speak English  
Child Care Centers  
• 
Must be part of a participating TA coach's current caseload 
• 
Have no plans to close in the coming year  
• 
Have at least one classroom serving preschool children  
• 
Serve at least lunch to the children  
• 
Not serve special needs children exclusively  
Child Care Providers  
• 
Teacher must be the lead teacher in a preschool classroom 
• 
Center directors and teachers must be able to read and speak English 
Number Of 
Subjects  
TA Coaches: BL n = 27; FU n = 26  
Child Care Centers: BL n = 97; FU n = 88  
Child Care Providers: BL n = 257; FU old n = 139, FU new n = 82 
Study Duration 
Each subject’s participation will last approximately 14 months; 1 month for baseline data 
collection, 12 months of intervention, and 1 month of follow up data collection. The entire study 
is expected to last approximately 3 ½ years. 
Study Phases  
(1) Screening and recruitment: During this phase we will identify and recruit TA coaches and get 
lists of the centers they serve. Centers will be screened for eligibility and recruited randomly. 
After a director and teachers consent, baseline data collection will be completed (2) Intervention: 
After baseline measurement, TAs will be randomly assigned to Basic or Enhanced Go NAPSACC 
implementation and the 12-month intervention will proceed (3) Follow-Up: After the 12-month 
intervention, follow up measures and process evaluations will be completed.  
Efficacy 
Evaluations 
• 
Primary Objective 
o Aim 1. Compare intervention impact on implementation of healthy weight practices. 
▪ 
EPAO-SR Nutrition and Physical activity environment scores. 
• 
Secondary Objectives 
o Aim 2. Evaluate adoption, implementation, and maintenance by group.  
▪ 
Percent of centers creating accounts, completing self-assessments, selecting 
goals, and creation of action plans will be captured by the Go NAPSACC 
website and extracted using the registration and detailed activity reports. 
o Aim 3. Examine how organizational factors predict implementation.  
▪ 
Surveys completed by directors, teachers, and TA coaches.  
▪ 
Fernandez's CFIR Inner Setting: Culture, Culture Stress, Culture Effort, 
Implementation Climate, Leadership Engagement, and Available Resources.  
▪ 
TCU's Organizational Readiness for Change: Networks and Communications 
and Access to Knowledge and Information.  
o Aim 4. Calculate incremental cost-effectiveness ratio for environment change.  
▪ 
Costs include TA coaches time and any resources required to train and 
support centers for 12 months. Costs will be tracked in the TA Activity and 

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supplemental resources log. These data will be used to calculate the total 
cost per center to implement Go NAPSACC. Cost will be used with EPAO-SR 
outcomes (aim 1) to calculate the incremental cost-effectiveness ratio. 
o Aim 5. Compare impact on children’s diet quality and physical activity at child care. 
▪ 
EPAO-SR food and meal reporting will be used to summarize center-level 
dietary intake and to calculate diet quality (Healthy Eating Index 2015) 
▪ 
EPAO-SR daily activities reporting will be used to summarize the activity 
levels of children. Outdoor time, active indoor time, vigorous minutes, and 
teacher ratings of activity level will be used to calculate an activity level 
index. 
Safety Evaluations Not Applicable, study is minimal risk 
Statistical And 
Analytic Plan 
The primary outcomes are change in nutrition and physical activity best practices in the Enhanced 
and Basic Go NAPSACC groups computed from the EPAO-SR collected from director and staff. 
 
Power and Sample Size: Power calculations specify the sample size needed to detect significant 
differences with 80% power, an alpha of 0.05, effect size of 0.6, and an ICC of 0.001. Cluster size is 
estimated at 10-15 centers per region. Based on these specifications, a sample size of 88 centers 
is needed. The final sample size of 97 centers allows for 10% attrition. Depending on the number 
and capacity of TA providers, we will need to recruit approximately 8 TA providers, each will need 
to recruit 12-13 child care centers. 
 
Statistical Analysis: Our primary analyses will test the hypothesis under the intent-to-treat (ITT) 
principle using Generalized Linear Mixed Models (GLMM) that account for the clustering of child 
care centers within regions/TAs. The primary GLMM will include a random intercept for region 
(b0) and fixed effects for the baseline value of the primary outcome (β1) and the intervention (β2) 
to test if the differences in mean changes in primary outcomes is zero, where β0 is the fixed 
intercept, and e is error. 
 
Change in Primary Outcome12m = β 0 + β1 Primary Outcomebaseline + β2 Intervention + b0 + e 
 
Baseline demographics and EPAO scores will be compared between centers with and without 
follow-up measures to inspect for potential bias. In addition, we will examine: 1) baseline 
covariates, determined a priori, relevant to change in EPAO scores; 2) interaction between 
treatment group and other covariates; and 3) completers only.  
 
Similar analytic models will be used to assess aims 2-5.  
DATA AND SAFETY 
MONITORING PLAN 
Data quality management and ongoing assessment of safety will be completed by a Data Safety 
Monitor Officer as needed.  
 

BACKGROUND AND RATIONALE  
 
Introduction 
More than 12 million children under the age of six participate in some form of child care, of which 56% 
are enrolled in center-based programs such as Head Start, preschool, and prekindergarten. Child care 
is a crucial setting for childhood obesity prevention initiatives given its known influence on children’s 
eating, physical activity, and weight. Drawing on the growing evidence from child care studies, national 
authorities (e.g., Institute of Medicine, American Academy of Pediatrics, American Public Health 
Association) recommend that child care programs serve healthy foods and limit unhealthy ones, 
provide adequate time for active play, limit screen time, provide healthy role models, and educate 
children about healthy lifestyle choices. Federally-funded programs (e.g., Child and Adult Care Food 
Program, Child Care Reauthorization Act) have also increased their emphasis on health promotion at 
child care, which will likely increase demand for effective strategies and tools to implement these 
evidence-based practices. Hence, implementation studies are a critical next step in identifying effective 
approaches for child care-based health promotion and obesity prevention. Existing studies offer little 
insight into scaling up and implementing these evidence-based practices in child care. The Nutrition 
and Physical Activity Self-Assessment for Child Care (NAPSACC) is a notable exception, offering a 
structured process that helps child care programs adopt and implement best practices for obesity 
prevention. NAPSACC has been promoted by the White House Task Force on Childhood Obesity as 
well as the CDC-funded program DP13-1305 (State Public Health Actions to Prevent and Control 
Diabetes, Heart Disease, Obesity and Associated Risk Factors and Promote School Health). Even so, 
implementation has been modest due to barriers such as a reliance on specially-trained technical 
assistance (TA) professionals (i.e., NAPSACC Consultants) and child care programs’ organizational 
capacity. “Go NAPSACC” was created to address this first barrier, translating core elements of the 
original program into user-friendly and interactive online tools that child care programs can use 
independently. While pilot studies suggest that Go NAPSACC retains its effectiveness in improving 
their practices, further study is needed to confirm its effectiveness and examine strategies to enhance 
its implementation. 
 
This study will address these gaps using a type 3 hybrid effectiveness-implementation design with a 
randomized controlled trial to evaluate the impact of Go NAPSACC on child care centers’ practices as 
well as the reach, adoption, implementation, and maintenance achieved with Go NAPSACC when 
using basic vs. enhanced implementation strategies (i.e., Basic Go NAPSACC vs. Enhanced Go 
NAPSACC). Working in Kentucky, the state with the sixth highest rate of child obesity, we will partner 
with Child Care Aware Kentucky and their existing regional TA providers to recruit 97 centers across 
the state. Enhanced implementation strategies, which are guided by the Quality Implementation 
Framework, will allow regional TA coaches to support centers’ general and intervention-specific 
capacity. Outcome measures, guided by RE-AIM  and the Consolidated Framework for Implementation 
Research (CFIR), will assess implementation outcomes (e.g., changes in centers’ practices, markers of 
implementation, costs, impact on children’s diet quality and physical activity) and determinants of 
implementation (e.g., contextual factors). 
 
1.1 
Name and Description of Investigational Product or Intervention  
Go NAPSACC is a suite of online tools designed to help child care programs improve their nutrition and 
physical activity practices. TA coaches from Child Care Aware in Kentucky will facilitate implementation 
of the Go NAPSACC program by introducing child care programs to the online tools and providing 
ongoing support using either a basic or enhanced implementation model.  
 
Basic Go NAPSACC. TA coaches assigned to Basic Go NAPSACC will invite the enrolled center 
director to register and create a Go NAPSACC account. The director will then participate in a 1-hour 
orientation provided by their TA coach to learn how to use Go NAPSACC's online tools and resources. 
Once the director is trained, they will be encouraged to complete 2 cycles of Go NAPSACC's 5-step 
improvement process focusing on child nutrition and physical activity. In each cycle of Go NAPSACC, 
the director will: Evaluate their current nutrition and physical activity practices using the self-
assessments in these two modules, choose at least 3 goals per module and create an action plan for 
each goal using the online tools that offer flexible step-by-step guidance, work to implement the action 
plan utilizing the tip & materials resource library, and log progress and completion of goals. Each cycle 

Page 8 of 20 
 
will take about 6 months. At the end of the 12 months, the director will retake the self-assessments on 
child nutrition and physical activity. Throughout this process, the director will receive brief check-ins 
from their TA coach via phone, email, or in-person. TA coaches will be asked to log their 
implementation activities using the TA Activity Log in their Consultant Tools.  
 
Enhanced Go NAPSACC. For centers receiving Enhanced Go NAPSACC, the director will work with 
their TA coach to identify an implementation team that will support the use of the program and 
improvements in nutrition and physical activity practices. The team will include a center administrator as 
well as two staff (at a minimum). Before starting Go NAPSACC, the team will work with their TA coach 
to conduct a readiness assessment of their center's needs, capacity, and resources. At a minimum this 
readiness check will be completed by all members of the team, but the team can also extend 
participation out to all center staff. The readiness check will be completed by center staff anonymously. 
Summarized results will be presented back to the team by the TA coach and used to identify priority 
issues for which the team would like extra support from the TA coach as they are working through Go 
NAPSACC. Once this readiness check is complete, the team will begin their use of Go NAPSACC. All 
members of the team will be invited to register for a Go NAPSACC account, linked back to their child 
care center. The team will then participate in a 1-hour orientation provided by their TA coach to learn 
how to use Go NAPSACC's online tools and resources. Once the team is trained, they will be 
encouraged to complete 2 cycles of Go NAPSACC's 5-step improvement process focusing on child 
nutrition and physical activity. The team will be asked to develop a 12-month plan to guide their Go 
NAPSACC efforts. In each cycle of Go NAPSACC, the team will: Evaluate their current nutrition and 
physical activity practices using the self-assessments in these two modules, Choose at least 3 goals 
per module and create an action plan for each goal using online tools that offer flexible step-by-step 
guidance, Work to implement the action plan and meet their chosen goals drawing from the tip & 
materials resource library, and Log progress and completion of goals. Each cycle will take 5-6 months. 
At the end of the 12 months, the team will retake the self-assessments on child nutrition and physical 
activity. Throughout this process, the team will receive brief check-ins from their TA coaches via phone, 
email, or in-person. These check-ins will include tailored prompts to offer extra guidance and support 
on prioritized issues identified from the needs assessment. In addition, teams from different centers 
within the same region will participate in 2-3 one-hour meetings hosted by the TA coach. These 
meetings will provide opportunities to reflect on their efforts and share lessons learned. TA coaches will 
be asked to log all of their implementation activities using the TA Activity Log in their Consultant Tools. 
TA coaches will participate in monthly conference calls hosted by a Go NAPSACC specialist to discuss 
progress, reflect on experiences, and promote peer learning. Further, TA coaches will be provided with 
2-3 one-on-one coaching sessions to address any specific questions or challenges encountered. 
 
1.4 
Relevant Literature and Data 
Center-level Nutrition and Physical Activity Environments (Primary Outcome Measure). We will use the 
Environment and Policy Evaluation and Observation as a Self-Report (EPAO-SR) (1) to measure best 
practices of nutrition and physical activity environments in child care centers. The EPAO-SR consists of 
over 800 items, takes about 45–60 min to complete, and includes a Director Survey and two teacher 
surveys (the Daily Survey and the General Survey). As recommended by the EPAO-SR protocol, when 
possible surveys are completed by the director and 2 separate classroom teachers; their responses 
were averaged to provide center-level estimates. 
 
The EPAO-SR Director Survey assesses the general child-care center environment and the 
presence/absence of written policies around nutrition and physical activity. In terms of nutrition, the 
Director Survey asks about menus, types of meals and snacks provided to children, food purchase and 
food preparation practices, and the presence of guidelines for foods brought from home. The survey 
also asks about the provision of nutrition education to parents, presence of written nutrition policies, 
and whether written policies addressed 19 practices related to food and feeding, nutrition education, 
and other nutrition topics (e.g., foods allowed for celebrations, food safety). In terms of physical activity, 
the Director Survey asks about the availability of specific types of outdoor play toys and equipment, 
variations in the outdoor play area landscape (e.g., presence of shade, fruit/vegetable gardens), and 

Page 9 of 20 
 
the provision of physical activity education to parents. Additional questions captured the presence of 
written physical activity policies and whether written policies addressed 15 specific practices related to 
physical activity, screen time, and physical activity education and training. The director will also fill out 
the food and beverages served section of the Daily Survey on two different days, which assesses food 
and beverages served to 3-5 year old children at the center. 
 
The EPAO-SR Teacher Surveys include sections on the physical activity part of the Daily Survey and a 
General Survey. The physical activity part of the Daily Survey assesses provisions physical activity in a 
preschool classroom. Questions ask about the opportunities for and minutes of physical activity (e.g., 
total active playtime, structured physical activity) and screen activities (e.g., television) provided to 
children in the classroom across the entire day. As recommended by the EPAO-SR protocol, the two 
teachers completing the physical activity section of the Daily Survey will be provided with days of the 
week they could report out on to ensure that they were reporting on physical activities provided to 
children on two separate weekdays. 
 
Teachers will also complete the EPAO-SR General Survey that assesses general practices and 
environments around nutrition and physical activity in preschool classrooms. Questions on the General 
Survey ask teachers to report on how often they engaged in practices such as: encouraging and 
modeling healthy eating and physical activity, using food, physical activity, and screen time for reward 
or punishment, or having informal discussions with children about nutrition and physical activity. 
Questions on the General Survey also capture the availability and accessibility of active play toys and 
equipment outdoors, and the types of screen equipment available for use with children in the 
classroom. Questions on professional development capture the frequency with which the teacher 
received nutrition and physical activity training annually and the specific topics addressed in the 
trainings. 
 
Items on the EPAO-SR will be used to assess compliance with nutrition and physical activity best 
practices, and ultimately, to calculate a combined nutrition and physical activity score. Nutrition best 
practices will be categorized into six domains: foods provided, beverages provided, feeding practices, 
the feeding environment, nutrition training and education, and nutrition policy. Physical activity best 
practices were categorized into six domains: active play and screen time provided, the indoor play 
environment, the outdoor play environment, physical activity and screen practices, physical activity 
training and education, and physical activity and screen policy. For each best practice, the EPAO-SR 
will be used to score compliance, ranging from 0 to 3; a score of “0” indicated non-compliance with the 
best practice, “1”, and “2”, represented partial compliance, while “3” indicated full compliance with the 
best practice. Best practice compliance scores within each domain will be averaged and then summed 
to create an overall nutrition (range = 0–18) and an overall physical activity score (range = 0–18). 
Finally, these overall nutrition and physical activity scores will be summed to create a single, combined 
nutrition and physical activity score (range = 0–36). Higher scores indicate compliance with a greater 
number of best practices, which translates to higher-quality environments. 
 
Contextual factors influencing implementation. As recommended by the CFIR framework (2), the most 
salient constructs were identified based on barriers identified in previous NAPSACC studies (3–7) and 
our extensive and ongoing work implementing Go NAPSACC. Prioritized constructs were 
operationalized for the child care setting and a nutrition and physical activity intervention. Self-
administered surveys completed by directors, teachers, and coaches at baseline and postintervention 
will be used to assess these constructs. Survey items draw from existing scales, including Fernandez’s 
Inner Setting Survey (ISS) (8), the Organizational Readiness for Change (ORC) survey (9,10), and 
Seward’s Theoretical Domains Framework Questionnaire (TDFQ) for child care (11–13). The ISS and 
ORC use a 5-point Likert scale, while the TDFQ uses a 7-point Likert scale (where 1 = strongly 
disagree and 5 or 7 = strongly agree).  
 
Cost-effectiveness. Cost of implementing Go NAPSACC using the basic and enhanced approaches will 
be tracked from the perspective of Child Care Aware of Kentucky, the organization that employs the 

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coaches. Coaches will keep records of time spent implementing Go NAPSACC, including both planning 
time and all direct contacts using the Go NAPSACC website’s Add TA Activity, making sure to also note 
any supplemental expenses. 
 
COVID Impact. As part of the relaunch of this project, we will have TA coaches and child care center 
directors fill out a survey about the impact COVID-19. TA coaches will be asked questions about the 
impact COVID has had on their ability to provide technical assistance to the child care centers and on 
their well-being.  Child care center directors will be asked questions on the impact COVID has had on 
their center, the families at their center, and their well-being. 
 
Participant characteristics. Participants will complete brief demographic surveys to assess age, sex, 
race, ethnicity, education, and income. For center directors, supplemental questions will be asked 
about center characteristics (e.g., years of operation, quality rating, participation in subsidy programs).  
 
1 
STUDY OBJECTIVES 
This study will use a type 3 hybrid effectiveness-implementation design with a randomized controlled 
trial to evaluate the impact of Go NAPSACC on child care centers’ practices as well as the adoption, 
implementation, and maintenance achieved with Go NAPSACC when using basic vs. enhanced 
implementation models (i.e., Basic Go NAPSACC vs. Enhanced Go NAPSACC).  
 
1.1 
Primary Objective 
• 
Aim 1. Compare Basic vs. Enhanced Go NAPSACC’s impact on centers’ implementation of 
healthy weight practices. 
o Hypothesis 1. Centers receiving Enhanced Go NAPSACC will make greater 
improvements in their food and activity provisions, staff practices, and center policies 
around children’s healthy eating and physical activity compared to centers receiving 
Basic Go NAPSACC. 
 
1.2 
Secondary Objective 
• 
Aim 2. Evaluate adoption, implementation, and maintenance of Basic vs. Enhanced Go 
NAPSACC.  
o Hypothesis 2. Reach, adoption, implementation, and maintenance (as defined by RE-
AIM) will be higher among centers receiving Enhanced Go NAPSACC compared to 
centers receiving Basic Go NAPSACC. 
• 
Aim 3. Examine how organizational factors predict implementation under Basic vs. Enhanced 
conditions.  
o Hypothesis 3. Positive organizational factors (as defined by CFIR), such as 
communication, culture, implementation climate, and readiness, will enhance 
implementation of Go NAPSACC. 
• 
Aim 4. Calculate incremental cost-effectiveness ratio of Basic vs. Enhanced Go NAPSACC in 
terms of changing centers’ environments.  
o Hypothesis 4. Both Enhanced and Basic Go NAPSACC will be cost-effective in terms of 
costs per outcome achieved, but Enhanced Go NAPSACC will be more efficient than 
Basic Go NAPSACC. 
• 
Aim 5. Compare Basic vs. Enhanced Go NAPSACC’s impact on children’s diet quality and 
physical activity at child care. 
o Hypothesis 5. Children enrolled at centers receiving Enhanced Go NAPSACC will have 
higher diet quality and spend more time in physical activity while at child care compared 
to children at centers receiving Basic Go NAPSACC. 
 
2 
INVESTIGATIONAL PLAN (brief overview) 
2.1 
Study Design 
This study will use a two-arm cluster randomized controlled design. The unit of randomization is the TA 
coach, and child care centers will be subject to the same randomization assignment as their TA coach. 

Page 11 of 20 
 
In order to be randomized, TA coaches must complete baseline measures and their associated centers 
must have all participants recruited and baseline data collection must be complete. Once randomized to 
either Basic Go NAPSACC or Enhanced Go NAPSACC, TAs and centers will be involved in 
intervention for 12 months. Then follow-up data will be collected from TAs and centers.  
 
2.2 
Allocation to Treatment Groups and Blinding (if applicable) 
The Project Manager from UNC will notify TA coaches of their assignment from the Co-Investigator, Dr. 
Derek Hales. The onsite manager from UKY will also be aware of the arm assignment. All other study 
personnel remained blinded to arm assignment. 
 
2.3 
Study Duration, Enrollment and Number of Subjects 
Study duration varies by participant type. TA coaches will be involved for approximately 18 months, 
center directors for approximately 16 months, and teachers for approximately 4 weeks.  
 
The goal is to enroll 97 centers, a director and at least 1 teacher at each center. When possible, we will 
recruit 2 teachers who work with children 3-5 years old at each center. We will enroll 8 TA coaches 
across the 8 regions of Kentucky through Child Care Aware of Kentucky (Northern Bluegrass, Southern 
Bluegrass, Salt River Trail, Eastern Mountain, Cumberland, Two Rivers, Jefferson, and The Lakes). 
This will be done across 4 waves. 
 
2.4 
Study Population 
For this study we recruited TA coaches and child care centers. From each center, we will recruit and 
enroll a director and 2 teachers.  
TA Coaches  
• 
Must either be Quality coach or a Healthy and Safety coach 
• 
Must be able to read and speak English  
Child Care Centers  
• 
Must be part of a participating TA coach's current caseload 
• 
Have no plans to close in the coming year  
• 
Have at least one classroom serving preschool children  
• 
Serve at least lunch to the children  
• 
Not serve special needs children exclusively  
Child Care Providers  
• 
Teacher must be the lead teacher in a preschool classroom 
• 
Center directors and teachers must be able to read and speak English 
 
3 
STUDY PROCEDURES   
3.1 
Screening/Baseline Visit procedures 
First, all TA coaches will attend a refresher orientation session where they will be refreshed and 
updated on the relaunch of the project and their roles as both participants and community partners. 
They will have the opportunity to ask questions and, if willing, sign an addendum consent form 
explaining the additions. Consented TA coaches will be asked to fill out demographics, TA CFIR 
context, and COVID-19 impact surveys online through a confidential Qualtrics link. For TA coaches 
(wave 1 and wave 2) with already enrolled centers, they will be emailed materials and trained on how to 
reach out to those centers to let them know that our team is relaunching the study and that the study 
team will be in touch soon to re-engage and consent them. For wave 3 and 4 TA coaches, at their 
online orientation they will be trained on how to introduce the research study to child care centers in 
their community using project-provided center recruitment materials. They will also be instructed to 
target these efforts toward a randomly selected list of centers (drawn from their current caseload) 
provided by the project team. They will be responsible for gauging initial interest, and then relaying that 
information to the research team. All TA coaches were previously trained on human subjects protection 
using the CIRTification curriculum (Anderson EE, CIRTification: Community Involvement in Research 
Training, Center for Clinical and Translational Science. University of Illinois at Chicago, 2011; available 

Page 12 of 20 
 
at: http://www.ccts.uic.edu/content/cirtification). The CIRTification curriculum is geared towards 
community partners and designed to increase their knowledge of research principles and methods. 
 
For wave 1 and wave 2 previously enrolled centers will be contacted by research staff to explain 
updated study details, answer questions, and confirm continued interest. For waves 3 and 4, research 
staff will follow up directly with all centers who expressed initial interest to their TA coach to confirm 
eligibility, review study details, answer questions, and confirm interest. Once a center director's 
eligibility and interest is confirmed, 2 lead preschool teachers will be randomly selected to take part in 
measures. The director will be emailed a flyer about the project to share with the preschool classroom 
teachers. Additionally, they will be emailed a confidential Qualtrics link to sign an online consent form 
and fill out an initial set of surveys. These surveys will include questions on their demographics, center 
demographics, their center's organization and capacity, and the impact of COVID-19. Additionally, 
directors will be asked to upload a month of menus and their parent and staff handbooks. Once the 
director has been given a couple days to share this information with the teachers, a research staff 
member will call back to talk to those classroom teachers (individually). Once two teachers eligibility 
and interest are confirmed, the research staff member will email the teacher confidential Qualtrics links, 
which will include an online consent form and several surveys. These surveys will include questions on 
demographics, their center's organization and capacity, their child nutrition and physical activity 
behaviors and practices, and nutrition and physical activity environment of their classroom and center. 
Additionally, directors will be emailed confirmation of teachers' enrollment and be sent a confidential 
Qualtrics link to fill out the final two surveys asking them about the foods and beverages served to 
preschool children on two days and their center’s policies and procedures related to nutrition and 
physical activity. 
 
TA coaches will be randomly assigned into either Basic or Enhanced Go NAPSACC, and they will use 
their assigned implementation model to deliver Go NAPSACC to all of their enrolled centers (cluster 
randomization). 
 
3.2 
Intervention/Treatment procedures (by visits) 
Go NAPSACC is a suite of online tools designed to helps child care programs improve their nutrition 
and physical activity practices. TA coaches from Child Care Aware in Kentucky will facilitate 
implementation of the Go NAPSACC program by introducing child care programs to the online tools 
and providing ongoing support using either a basic or enhanced implementation model. To prepare TA 
coaches for this role, they will be trained and support by Go NAPSACC specialists (program experts 
from the research team). 
• 
TA coaches randomized to Basic Go NAPSACC will participate in 2 hour-and-a-half-long 
training webinars, complete homework over a 3-week period, and have a 30 minute video 
conference call check-in meeting with the outreach specialist one month after training is 
complete. Their training will cover the importance of child care programs in encouraging 
children's healthy eating and physical activity behaviors, the purpose of Go NAPSACC, Go 
NAPSACC's 5-step improvement process and the tools available for child care providers 
("Provider Tools"), their role in implementation, the tools available for coaches to support 
implementation ("Consultant Tools"), how to provide support remotely, and how COVID-19 may 
impact Go NAPSACC best practices. Wave 1 and 2 TA coaches will be refreshed on similar 
topics over two trainings (1-hour each) administered over a 2-week period. The 1-month check-
in meeting is to go over any questions or concerns coaches have with implementing the project. 
• 
TA coaches randomized to Enhanced Go NAPSACC will participate in 4 hour-long training 
webinar sessions and complete homework over a 3-5-week period. Their training will cover all 
topics in the Basic training plus their role in enhanced implementation, the purpose of the 
readiness check and how to administer it, and resources available to provide tailored support 
throughout implementation based on findings from the readiness check. Wave 1 and 2 TA 
coaches will be refreshed on these same topics through 2 one-and-a-half hour trainings. During 
implementation, TA coaches will participate in monthly conference calls hosted by a Go 
NAPSACC specialist to discuss progress, reflect on experiences, and promote peer learning. 

Page 13 of 20 
 
During the first few monthly calls, TA coaches will be further refreshed on training relevant to 
where they are in the process through a part 3 training. After training, coaches will be asked to 
evaluate the effectiveness of the training during those calls through online surveys. Further, TA 
coaches will be provided with 2-3 one-on-one coaching sessions to address any specific 
questions or challenges encountered. 
 
 
Basic Go NAPSACC 
 
For centers receiving Basic Go NAPSACC, the director will be invited by their TA coach to register for a 
Go NAPSACC account. The director will then participate in a 1-hour orientation provided by their TA 
coach to learn how to use Go NAPSACC's online tools and resources. Once the director is trained, they 
will be encouraged to complete 2 cycles of Go NAPSACC's 5-step improvement process focusing on 
child nutrition and physical activity. In each cycle of Go NAPSACC, the director will: 
• 
Evaluate their current nutrition and physical activity practices using the self-assessments in 
these two modules, 
• 
Choose at least 3 goals per module and create an action plan for each goal using online tools 
that offer flexible step-by-step guidance, 
• 
Work to implement the action plan and meet their chosen goals drawing from the tip and 
materials resource library, and 
• 
Log progress and completion of goals. 
 
Each cycle will take about 6 months. At the end of the 12 months, the director will retake the self-
assessments on child nutrition and physical activity. Throughout this process, the director will receive 
brief check-ins from their TA coaches via phone, email, or in-person. TA coaches will be asked to log 
their implementation activities using the TA Activity Log in their Consultant Tools. 
 
Enhanced Go NAPSACC 
For centers receiving Enhanced Go NAPSACC, the director will work with their TA coach to identify an 
implementation team to support the use of the program and improvements in nutrition and physical 
activity practices. The team will include a center administrator as well as two staff (at a minimum). 
Before starting Go NAPSACC, the team will work with their TA coach to conduct an assessment of their 
center's needs, capacity, and resources. At a minimum this readiness check will be completed by all 
members of the team, but the team can also extend participation out to all center staff. The readiness 
check will be completed anonymously and returned to the TA coach for scoring. Summarized results 
will be presented back to the team by the TA coach and used to identify priority issues for which the 
team would like extra support from the TA coach as they are working through Go NAPSACC. 
 
Once this readiness check is complete, the team will begin their use of Go NAPSACC. All members of 
the team will be invited to register for a Go NAPSACC account, linked back to their child care center. 
The team will then participate in a 1-hour orientation provided by their TA coach to learn how to use Go 
NAPSACC's online tools and resources. Once the team is trained, they will be encouraged to complete 
2 cycles of Go NAPSACC's 5-step improvement process focusing on child nutrition and physical 
activity. The team will be asked to develop a 12-month plan to guide their Go NAPSACC efforts. In 
each cycle of Go NAPSACC, the team will: 
• 
Evaluate their current nutrition and physical activity practices using the self-assessments in 
these two modules. 
• 
Choose at least 3 goals per module and create an action plan for each goal using online tools 
that offer flexible step-by-step guidance. 
• 
Work to implement the action plan and meet their chosen goals drawing from the tip and 
materials resource library. 
• 
Log progress and completion of goals. 
 
Each cycle will take about 5-6 months. At the end of the 12 months, the team will retake the self-
assessments on child nutrition and physical activity. Throughout this process, the team will receive brief 
check-ins from their TA coaches via phone, email, or in-person. These check-ins will include tailored 

Page 14 of 20 
 
prompts to offer extra guidance and support on prioritized issues identified from the needs assessment. 
In addition, teams from different centers within the same region will participate in 2-3 one-hour 
meetings hosted by the TA coach. These meetings will provide opportunities to reflect on their efforts 
and share lessons learned. TA coaches will be asked to log all of their implementation activities using 
the TA Activity Log in their Consultant Tools. 
 
3.3 
Follow- up procedures (by visits) 
Measures from Baseline will be repeated following 12 months of Go NAPSACC participation. Data 
collection will use the same procedures explained in 3.1. The only addition is that process evaluation 
questions were added to the Qualtrics link, including questions around the delivery of Basic or 
Enhanced Go NAPSACC and cost-effectiveness.  
 
In addition, trained research staff will complete interviews over Zoom (via link or call-in phone number) 
for all TA coaches in a group format based on wave and arm assignment. Trained research staff will 
also complete Zoom interviews with randomly selected center directors from both arms and teachers 
from the Enhanced Go NAPSACC arm. Interviews will last approximately 1 hour and will be audio 
recorded and notes will be taken. 
 
3.4 
Unscheduled visits 
N/A 
3.5 
Concomitant Medication documentation 
N/A 
3.6 
Rescue medication administration (if applicable) 
N/A 
3.7 
Subject Completion/Withdrawal procedures 
Participants may withdraw at anytime. They are asked to inform the study team by phone or email. If 
the director withdraws they are asked a few follow-up questions to assess reasons for withdrawal. 
There are no adverse event criteria for individual withdrawal or full study cessation. 
 
3.8 
Screen failure procedures 
N/A 
4 
STUDY EVALUATIONS AND MEASUREMENTS  
All baseline measurement will be collected through online Qualtrics surveys. Once TA coaches agree to 
be a part of the study they are emailed a Qualtrics survey link. Surveys include consent, demographics 
(general personal demographics; 10 questions), COVID impact (impact on job and work with child care 
centers; 11 questions), modified Consolidated Framework for Implementation Research (CFIR) 
questions. The CFIR survey for the TA coaches consists of 48 questions and includes questions from 
CFIR Constructs: Implementation Climate, Readiness for Implementation- Available Resources, Access 
to Information and Knowledge, Knowledge and Beliefs About the Intervention, and Self-Efficacy.  
 
Similarly, when directors agree to be enrolled into the study they are emailed a consent form, 
demographics (general personal and center level demographics; (18 items), COVID impact (impact on 
center; 24 items), and modified CFIR, Qualtrics survey link (80 items).CFIR constructs for directors 
include: Networks and Communications, Climate, Implementation Climate, Readiness for 
Implementation- Available Resources, Access to Information and Knowledge, Knowledge and Beliefs 
About the Intervention, and Self-Efficacy. At this time, they may also upload a month of menus and 
policy handbooks (to be coded later by research staff). They are also sent a Qualtrics links to the menu 
and policy section and two days of the Foods and Beverages provided sections of the Environment and 
Policy Assessment and Observation- Self Report (EPAO-SR).  
 
Finally, when child care center teachers were enrolled into the study they were emailed a consent form, 
demographics (personal demographics; 9 items), and CFIR (82 items) Qualtrics survey link. CFIR 
constructs are the same as the directors noted above. Each teacher is also sent one other Qualtrics link 
to record normal daily activities for one day (each teacher reports about a different day of the week).  

Page 15 of 20 
 
 
After randomization and 12-months of intervention, TA coaches and child care center providers will 
participate in follow-up measures. Similar to baseline, most follow-up measures were done through 
online Qualtrics links. At follow-up TAs were emailed a link to fill out a set of surveys. Surveys will 
include the same CFIR from baseline and some process questions around their experience with Basic 
or Enhanced Go NAPSACC with their centers. For the center director these measures will include 
modified center demographics, the same CFIR survey and EPAO-SR questions from baseline, and 
some process evaluation questions around their experiences with Basic or Enhanced Go NAPSACC 
and costs. Child care center teachers will fill out the same CFIR and EPAO-SR surveys from baseline 
and additional process evaluation questions around their experiences with Basic or Enhanced Go 
NAPSACC. All TAs will be interviewed in a group format and interviews will be approximately 1- 1 ½ 
hours. They will be audio recorded and notes will be taken. Trained research staff will also complete 
Zoom interviews with randomly selected center directors and when relevant their implementation team 
regarding their experience using Go NAPSACC and making improvements to nutrition and physical 
activity practices. These interviews will last approximately 1 hour and will be audio recorded and notes 
will be taken. 
 
4.1 
Efficacy Evaluation (if applicable) 
N/A 
4.2 
Pharmacokinetic Evaluation ( if applicable) 
N/A 
4.3 
Safety Evaluations 
N/A 
 

STATISTICAL CONSIDERATIONS  
 
4.4 
Statistical Methods 
Primary Aim: 
Our primary analyses will test the hypothesis under the intent-to-treat (ITT) principle using Generalized 
Linear Mixed Models (GLMM) that account for the clustering of child care centers within regions/TA. 
The primary GLMM will include a random intercept for region (b0) and fixed effects for the baseline 
value of the primary outcome (β1) and the intervention (β2) to test if the differences in mean changes in 
primary outcomes is zero, where β0 is the fixed intercept, and e is error. 
 
Change in Primary Outcome12m = β 0 + β1 Primary Outcomebaseline + β2 Intervention + b0 + e 
 
To further explore the intervention effect, we will examine: 1) baseline covariates relevant to change in 
EPAO scores; 2) interaction between treatment group and other covariates; and 3) completers only. 
Baseline demographics and EPAO scores will be compared between centers with and without follow-up 
measures to inspect for potential bias. 
 
Secondary Aims: 
Analysis for secondary aims will use statistical models like those applied for primary analysis. 
Generalized Linear Mixed Models (GLMM) that account for the clustering of child care centers within 
regions/TA under the intent to treat principle will be utilized. The primary GLMM will include a random 
intercept for region and fixed effects for the baseline value of the outcome and the intervention. 
Interaction terms will be added to models where needed. Specifics relevant to aims 2-5 include: 
 
Aim 2. Data used to evaluate adoption, implementation, and maintenance of Basic vs. Enhanced Go 
NAPSACC will be compiled from the Go NAPSACC registration reports and activity reports (Center and 
TA). Outcomes computed from these reports include: registration, account initiation, first self-
assessments, selection of goal, creating action plans, post cycle self-assessment, TA contacts, and TA 
implementation activities.  
 
Aim 3. Section 1.4 includes a summary of the organizational factors outcomes that will be assessed. In 
short Fernandez's CFIR Inner Setting: Culture, Culture Stress, Culture Effort, Implementation Climate, 
Leadership Engagement, and Available Resources along with TCU's Organizational Readiness for 
Change: Networks and Communications and Access to Knowledge and Information will be collected 
from surveys completed by directors, teachers, and TA coaches. Organizational outcomes will be 
examined as moderators of the intervention effects in statistical models. Both continuous and 
categorical (quartiles) moderation effects will be tested.  
 
Aim 4. Details about computing program cost can be found in section 1.4. The average incremental 
cost of delivering Enhanced Go NAPSACC will be divided by the incremental change in effectiveness 
(relative to Basic Go NAPSACC) to quantify the incremental cost-effectiveness ratio. The Incremental 
Cost-Effectiveness Ratio includes costs over the time period of the study and effectiveness measured 
by the unit increase in EPAO score. Standard GLMM models will be used to compare cost ratios 
between intervention groups.  
 
Aim 5. Diet and activity information from the EPAO-sr (see section 1.4) will be used to diet quality of the 
food served to children and the physical activity time provided. Food and meal reporting will be used to 
summarize center-level dietary intake and to calculate diet quality (Healthy Eating Index 2015), while 
daily activities reporting will be used to summarize the activity levels of children. Outdoor time, active 
indoor time, vigorous minutes, and teacher ratings of activity level will be used to calculate an activity 
level index. Analysis and statistical models used to evaluate this aim will be nearly identical to those for 
primary analysis. 
 
4.5 
Sample Size and Power  
The primary outcome for this study is change in centers’ implementation of nutrition and physical 
activity evidence-based best practices the Enhanced and Basic Go NAPSACC arms based on scores 

Page 17 of 20 
 
from the EPAO. Power calculations in Table specify the sample size needed to detect significant 
differences in changes with 80% power and an alpha of 0.05. An effect size of 0.6 was used, 
representing a conservative estimate based on published NAPSACC studies (with effects ranging from 
0.4 to 1.1). An ICC of 0.001 is included based on our Go NAPSACC pilot (31 centers from 3 regions), 
which found negligible correlation (> 0.001) in EPAO scores between centers located within the same 
region. Cluster size is estimated at 10-15 centers per region. While regional TA providers likely have a 
larger caseload, only a sample of centers will be recruited to take part. Based  
on these specifications, a sample size of 
88 centers is needed detect an effect size 
of 0.60 with 80% power and a 0.05 level of 
significance. The final sample size of 97 
centers allows for 10% attrition, which 
should be more than sufficient based on 
previous work with child care centers that 
has demonstrated low center attrition 
(<10%). Depending on the number and 
capacity of TA providers, we will need to 
recruit approximately 8 TA providers, each of which will need to recruit 12-13 child care centers. 
 
4.6 
Interim Analysis 
N/A 
 
5 
STUDY INTERVENTION (DEVICE, DRUG, OR OTHER INTERVENTION) 
 
See section 3.2 for further intervention details. No device or drug studied. 
 
6 
STUDY INTERVENTION ADMINISTRATION (IF APPLICABLE)  
Blinding and randomization procedures already explained in sections 2.1, 3.1, and 3.2  
 
7. 
 SAFETY MANAGEMENT  
Given the low potential for risk of harm to participants, the data safety monitoring (DSM) plan 
emphasizes close monitoring of the trial by the principal investigator, project manager, onsite manager, 
study statistician, and a DSM officer. This DSM team will regularly review subject accrual, adherence to 
study protocols, dropouts, adverse events, and participant confidentiality. Specifically, the principal 
investigator and project manager will meet on a biweekly basis throughout all phases of the project to 
review the study progress and any concerns about quality control and/or participant safety. Additionally, 
they will review progress with the DSM officer quarterly and within two weeks when adverse events 
occur. Prior to subject engagement, the full DSM team will meet in person to review study protocols 
(e.g., recruitment, consent, adverse events monitoring), finalize the DSM plan, and establish a template 
for quarterly reporting. During active subject engagement, the onsite manager and Kentucky-based co-
investigator will participate in biweekly meetings with the principal investigator and project manager. 
The project manager will also work with the study statistician to prepare reports for the DSM officer on 
participant accrual, adherence, and withdrawal/dropouts based on the approved reporting template. 
The DSM officer will be asked to review and approve these reports. In addition to these quarterly 
reports, any adverse events or concerns regarding confidentiality will be reviewed by the DSM officer 
within two weeks of the event. We do not anticipate the need for interim analyses for early termination 
due to intervention effectiveness or futility. We feel that this level of monitoring is commensurate with 
the risks and complexity of the proposed study. 
 
Measurement and Reporting of Adverse Events 
At enrollment, we will inform center staff and TA providers to contact the project manager if they feel an 
injury or illness may have occurred to them or a child in their care as a result of their participation in this 
study. If such an event occurs, the project manager will collect a detailed description of the event, the 
adverse outcome, severity of the adverse event, and whether or not participants viewed it as related to 
the study. This report will then be reviewed by the DSM officer, who will categorize it as: definitely 
Power calculations 
alpha 
power 
effect 
size 
ICC 
cluster 
size 
suggested 
sample size 
# of 
clusters 
0.05 
0.2 
0.5 
0.001 
10 
126.7 
12.7 
0.05 
0.2 
0.6 
0.001 
10 
88.0 
8.8 
0.05 
0.2 
0.7 
0.001 
10 
64.6 
6.5 
0.05 
0.8 
0.5 
0.001 
15 
127.3 
8.5 
0.05 
0.8 
0.6 
0.001 
15 
88.4 
5.9 
0.05 
0.8 
0.7 
0.001 
15 
65.0 
4.3 

Page 18 of 20 
 
unrelated, or unlikely, possibly, probably, or definitely related to study participation. Although some 
injuries may be anticipated as a result of an intervention that promotes regular physical activity for 
children, in our previous center-based work, no injuries related to participation occurred. We therefore 
anticipate that injury risk is present, but minimal. Adverse event reports will be submitted to the IRB 
after they are completed by the DSM officer. A summary of these reports will be submitted to the NIH 
project officer on an annual basis as needed. 
 
Participant Confidentiality 
This study will collect provider and organizational-level measures. Collection of data is for research 
purposes only and is kept in strict confidence by study personnel. Data collection forms and contact 
information used to implement the intervention will be kept in locked file cabinets in the UNC-Chapel 
Hill study offices. Online data collection will occur through Qualtrics and is password protected. 
Participants will be assigned an ID number which will be used to minimize the use of names on forms. 
Any forms linking participant ID and name will be stored separately, away from other survey data. 
Electronic data files will be stored on a secure, password protected server. Except when required by 
law, participants will not be identified by name, address, telephone number, or any other direct personal 
identifier in study records disclosed outside of UNC-Chapel Hill. Written informed consent will be 
obtained using a UNC approved consent form. 
 
8.  
DATA COLLECTION AND MANAGEMENT  
Due to study modifications associated with COVID 19 data collection utilized remote collection methods 
including phone calls, online surveys, and video conferencing. All methods and modifications were 
approved by the UNC IRB and funding officers. Data completion and quality was monitored by the 
project manager and data manager during this transition and throughout baseline and follow-up 
assessments. All data are housed on secure university servers with direct access limited to relevant 
research personnel (PI, statistician, project and data managers). De-identified data will be housed for 
long term access using the UNC data storage system. A more complete description of the important 
and maintenance of participant confidentiality can be found in section 7 (above).  
 
9.        RECRUITMENT STRATEGY 
The 97 centers will be recruited over 4 waves from the 11 regions that span the state. We will work with 
Child Care Aware Kentucky and identify Technical Assistants in each region.  We will then identify all 
licensed child care centers that each TA works with and randomly select a sample of 25 centers for 
each TA to target for recruitment. TA providers will help distribute recruitment materials (provided by the 
project) to the child care centers and gauge initial their interest. The names and contact information 
from interested centers will be supplied to the project team for follow-up. Trained research assistants 
will follow up with interested centers by telephone to review study details, confirm eligibility, and verify 
interest of the center. Once participation is confirmed, two 3-5 year old classroom teachers will be 
chosen to be recruited. A follow up email with information to go over with potential teachers. Then those 
teachers would be called at the center and recruited by phone to review study materials and confirm 
interest.  
 
10. 
CONSENT PROCESS 
 
Once providers have been explained the study over the phone and eligibility and interest is confirmed 
consent will be collected online via a Qualtrics link that is sent through a study email by a study staff 
member. A downloadable link will be included in the Qualtrics and a blank copy of the consent form will 
be attached to the email. Participants can take as much time as they would like to look over the consent 
form and ask questions before signing online or on paper. If paper is requested a postage provided 
envelope will be provided to mail back their signed consent form. These paper copies will be kept away 
from other data in locked cabinets only accessible by study staff.  
 

Page 19 of 20 
 
11.     PLANS FOR PUBLICATION  
Study results and additional findings with published in 2-3 manuscripts submitted to peer reviewed 
journals. A protocol paper has been published.   
 
12.      REFERENCES 
 
1.    Ward DS, Mazzucca S, McWilliams C, Hales D. Use of the Environment and Policy Evaluation and 
Observation as a Self-Report Instrument (EPAO-SR) to measure nutrition and physical activity 
environments in child care settings: validity and reliability evidence. Int J Behav Nutr Phys Act. 2015 Sep 
26;12:124. 
2.    Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of 
health services research findings into practice: a consolidated framework for advancing implementation 
science. Implement Sci. 2009 Aug 7;4:50. 
3.    Ward DS, Benjamin SE, Ammerman AS, Ball SC, Neelon BH, Bangdiwala SI. Nutrition and physical 
activity in child care: results from an environmental intervention. Am J Prev Med. 2008 Oct;35(4):352–6. 
4.    Benjamin SE, Ammerman A, Sommers J, Dodds J, Neelon B, Ward DS. Nutrition and physical activity 
self-assessment for child care (NAP SACC): results from a pilot intervention. J Nutr Educ Behav. 2007 
Jun;39(3):142–9. 
5.    Battista RA, Oakley H, Weddell MS, Mudd LM, Greene JB, West ST. Improving the physical activity and 
nutrition environment through self-assessment (NAP SACC) in rural area child care centers in North 
Carolina. Prev Med. 2014 Oct;67 Suppl 1:S10-6. 
6.    Martin SL, Martin MW, Cook B, Knaus R, O’Rourke K. Notes from the field: the evaluation of Maine 
Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) experience. Eval Health 
Prof. 2015 Mar;38(1):140–5. 
7.    Dinkel D, Dev D, Guo Y, Hulse E, Rida Z, Sedani A, et al. Improving the Physical Activity and Outdoor 
Play Environment of Family Child Care Homes in Nebraska Through Go Nutrition and Physical Activity 
Self-Assessment for Child Care. J Phys Act Health. 2018 Oct 1;15(10):730–6. 
8.    Fernandez ME, Walker TJ, Weiner BJ, Calo WA, Liang S, Risendal B, et al. Developing measures to 
assess constructs from the Inner Setting domain of the Consolidated Framework for Implementation 
Research. Implement Sci. 2018 Mar 27;13(1):52. 
9.    Lehman WEK, Simpson DD, Knight DK, Flynn PM. Integration of treatment innovation planning and 
implementation: strategic process models and organizational challenges. Psychol Addict Behav. 2011 
Jun;25(2):252–61. 
10.   Lehman WEK, Greener JM, Simpson DD. Assessing organizational readiness for change. J Subst 
Abuse Treat. 2002 Jun;22(4):197–209. 
11.   Seward K, Wolfenden L, Wiggers J, Finch M, Wyse R, Oldmeadow C, et al. Measuring implementation 
behaviour of menu guidelines in the childcare setting: confirmatory factor analysis of a theoretical 
domains framework questionnaire (TDFQ). Int J Behav Nutr Phys Act. 2017 Apr 4;14(1):45. 
12.   Huijg JM, Gebhardt WA, Dusseldorp E, Verheijden MW, van der Zouwe N, Middelkoop BJC, et al. 
Measuring determinants of implementation behavior: psychometric properties of a questionnaire based 
on the theoretical domains framework. Implement Sci. 2014 Mar 19;9:33. 
13.   Huijg JM, Presseau J. Health Psychology and Implementation science intandem: developing 
questionnaires to assess theoretical domainsandmultiple goal pursuit. EurHealth Psychol. 
2013;15(1):17–21. EJHP. 2013;15(1):17–21.  

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APPENDIX