Evaluating Coordination of Care Between Pediatricians and Women Infants & Children (WIC) Nutritionists: Early Obesity Prevention for WIC Mothers and Children
Phase: NA
Conditions: Childhood Obesity
Sponsor: Penn State University

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Coordination of Care between WIC Nutritionists and Pediatric Physicians at 
Geisinger Health System
Principal Investigator:
Lisa Bailey-Davis, DEd, RD
Associate Director,
Geisinger Obesity Institute
Assistant Professor, Department of Epidemiology and 
Health Services Research
570-214-9625
Sub- Investigators: 
William J. Cochran, MD
Pediatric Gastroenterology
Geisinger Health System
Sean M. O’Dell, PhD, LP, HSP-P
Associate
Pediatric Integrated Primary Care
Assistant Professor
Department of Epidemiology and Health Services Research
Collaborator(s):
Jennifer Savage Williams, PhD
Interim Director, Center for Childhood Obesity Research
Assistant Professor, Department of Nutritional Sciences
Penn State University
Lindsey Brubaker, MPH
Study Coordinator
Penn State University
Michele Marini, MS
Biostatistician
Penn State University

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Christopher Seiler, MBA
Project Manager
Geisinger Obesity Institute
Project Coordinator: 
Jacob Mowery
Project Coordinator
Geisinger Center for Health Research
TABLE OF CONTENTS 
1
ABBREVIATIONS USED IN THE PROTOCOL
................................................................................................................................................5
2
ABSTRACT
................................................................................................................................................6
3
BACKGROUND AND SIGNIFICANCE
................................................................................................................................................7
4
HYPOTHESIS AND SPECIFIC AIMS
................................................................................................................................................9
4.1
Hypothesis ....................................................................................................................9
4.2
Specific Aim 1..............................................................................................................9
4.3
Specific Aim 2..............................................................................................................9
5
PRELIMINARY DATA
................................................................................................................................................9
6
STUDY DESIGN
..............................................................................................................................................10
6.1
Description..................................................................................................................10
6.2
Study Population.........................................................................................................10
6.2.1
Approximate Number of Subjects................................................................10
6.2.2
Inclusion Criteria..........................................................................................10
6.2.3
Exclusion Criteria.........................................................................................10
6.3
Recruitment.................................................................................................................11
6.4
Study Duration............................................................................................................12
6.4.1
Approximate Duration of Subject Participation...........................................12

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6.4.2
Approximate Duration of Study...................................................................12
6.5
Procedures...................................................................................................................12
6.5.1
Study Time and Events Table ......................................................................13
6.5.2
Study Flow Diagram ....................................................................................15
Footnote:  Infant growth measures include rapid weight gain measured by change in 
weight-for-age z-score................................................................................................16
6.6
Statistics......................................................................................................................16
6.6.1
Statistical Analysis Plan...............................................................................16
6.6.2
Statistical Power and Sample Size Considerations ......................................17
6.7
Data Management.......................................................................................................17
6.7.1
Data Collection and Storage.........................................................................17
6.7.2
Records Retention ........................................................................................18
7
PROTECTION OF HUMAN SUBJECTS
..............................................................................................................................................18
7.1
Informed Consent .......................................................................................................18
7.2
Protection of Human Subjects Against Risks.............................................................18
7.3
Data Monitoring Plan .................................................................................................20
8
REFERENCES
..............................................................................................................................................21
9
ATTACHMENTS
..............................................................................................................................................26
9.1
Attachment 1: EHL Screening Tool ...........................................................................26
9.2
Attachment 2: Pre-Screening and Recruitment Packet...............................................26
9.3
Attachment 3: Enrollment Survey Packet...................................................................26
9.4
Attachment 4: 2 Month Survey Packet.......................................................................26
9.5
Attachment 5: 5 Month Survey Packet.......................................................................26
9.6
Attachment 6: 7 Month Survey Packet.......................................................................26
9.7
Attachment 7: Coordination of Care Measures ..........................................................26
9.8
Attachment 8: WIC Brochure.....................................................................................26
9.9
Attachment 9: MyGeisinger Enrollment Instructions.................................................26

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9.10 Attachment 10: WEE Information Sheet....................................................................26
9.11 Attachment 11: Patient Involvement in Care Questionnaire ......................................26
9.12 Attachment 12: RCT Informed Consent.....................................................................26     

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1
 ABBREVIATIONS USED IN THE PROTOCOL
Abbreviation
Term
AAP
AE
American Academy of Pediatrics
Adverse event
BMI
EHL
EHR
GIRB
GMC
GWV
Body Mass Index
Early Healthy Living/Lifestyles
Electronic Health Record
Geisinger IRB
Geisinger Medical Center
Geisinger Wyoming Valley
HALF
ID
IRB
MRN
Healthy Active Living for Families
Identity
Institutional Review Board
Medical Record Number
PCP
PHI
PSL
SAE
SES
WIC
Primary Care Provider
Protected Health Information
Pediatric Service Line
Serious adverse event
Socio-economic status
Women, Infants, and Children Program

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2
ABSTRACT
This project aims provide better care and improve population health through coordination of 
community and clinical services for a high-risk, vulnerable population of infants and 
mothers.   Specifically, this project will coordinate care for Geisinger patients who are also 
participating in the Women, Infants, and Children (WIC) Program.  More than half of the United 
States population participates in the federally-funded WIC program, originally established in 
1971.  Mothers of WIC participating infants receive nutrition education at least 5 times during 
the infant's first year of life and during which time they also receive nutrition education from the 
infant's physician at least 6 times during well child visits.  Mothers report receiving inconsistent 
and conflicting nutrition messages, particularly about growth, and this is a point of their 
frustration with community and clinical care.  Poor messaging impedes knowledge, behavior, 
and attitudes toward healthy eating and growth, and may be associated with higher rates of rapid 
weight gain in infancy and subsequent childhood obesity.  This project aims to improve 
consistency of nutrition, feeding, and growth messaging through training and coordination across 
WIC community and Geisinger clinical settings. 
This prospective study will have two sequential phases 1) observational study; 2) interventional 
randomized controlled trial.  Mother/guardian-infant pairs of infants that have a Geisinger 
primary care provider in the Geisinger Pediatric Service Line and who participate or are eligible 
and plan to participate in WIC will be enrolled in a single phase of the study.  The purpose of the 
observational phase is to obtain a baseline of participant measures with usual, uncoordinated care 
in the Pediatric Service Line and WIC.  The purpose of the randomized controlled trial is to 
evaluate the differences between groups that experience coordinated versus uncoordinated care.  
Two phases are necessary because the Geisinger Pediatric Service Line (PSL) implements a 
standard of care, known as Early Healthy Living/Lifestyles (EHL) screening, that is not 
implemented nationally and potentially limits the generalizability of study findings.  In prior 
studies (IRB# 2012-0363), the EHL screening tool has been evaluated.  The EHL screening is 
undergoing modifications to improve health literacy, numeracy, and alignment with evidence-
based recommendations.  Thus, the PSL will temporarily turn off the EHL screening for these 
revisions and staff training, thus allowing for an observational phase of usual, uncoordinated 
care.  The updated EHL screening tool (Attachment 1) will be made available as standard of care 
in the PSL when phase 2 begins [Note that this is a clinical screening tool and not a study 
questionnaire]. Mother/guardian-infant dyads in both groups of phase 2 will be exposed to the 
EHL screening but only one group will have coordinated care with WIC. Knowledge, behavior, 
and attitudes are expected to be more desirable among mother/guardian-infant pairs with 
coordinated care when compared to those receiving status quo.  Additionally, infants with 
coordinated care are expected to have slower (as opposed to rapid and risky) weight gains in 
comparison to infants with uncoordinated care.  Mothers/guardians are expected to indicate 
greater satisfaction with coordinated versus uncoordinated care. 

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3
BACKGROUND AND SIGNIFICANCE
Rationale: WIC nutritionists and PCPs are viewed as credible and trustworthy sources of 
parenting and feeding information during the first few years of life.1 Two issues call for the need 
to coordinate care and messages: 1) WIC mothers, a high risk population, are regularly exposed 
to care in two settings (health care and community) but the care, i.e., preventative education, is 
not coordinated resulting in conflict in messaging and confusion among WIC mothers; and 2) 
care in both settings is oriented toward primary prevention with similar institutional expectations 
and situational challenges that could be overcome by coordination between settings. A series of 
reports from the Institute of Medicine, the American Academy of Pediatrics, and the White 
House Task Force on Childhood Obesity call for a coordination of efforts locally, between 
primary care and community programs like WIC, on issues such as consistent messages to 
enhance childhood obesity prevention.2, 3, 4
Existing knowledge: WIC mothers and children experience expert-level preventive care, i.e., 
nutrition messages and parenting education, in two distinct settings- community and health care, 
but care is not coordinated and ultimately is perceived as inconsistent among WIC mothers.5, 6, 7 
Inconsistent messages contribute to parent confusion about effective preventive practices. 
Adding further complexity to mother’s learning is the need to synthesize inconsistent 
information with well-intentioned but often conflicting, inaccurate advice available on the web 
that is often not evidence based.8, 9 This cluttered context for learning in the midst of an 
immediate need for credible and consistent information calls for coordinated care through WIC 
nutritionists and PCPs to exponentially enhance prevention opportunities.10
Gaps: Recent national guidelines that address prevention and management of childhood obesity 
and its comorbidities11, 12 recommend assessing/monitoring to occur in primary care settings, 
recognizing that health care-centered efforts alone cannot affect change, but they can 
complement and potentially enhance public health efforts such as WIC.13 Because obesity is a 
complex, multifactorial condition, efforts to leverage and more importantly, coordinate care and 
touch-points across settings are likely to offer the best opportunities for prevention. WIC 
nutritionists and PCPs share an appreciation for obesity prevention despite shared barriers to 
prevention care: limited time, training/skill, resources, and lack of parent interest.14 In the context 
of advanced health information technology, Geisinger has reliable approaches and tools that are 
available and tested to reduce these barriers with automation, data synthesis, and risk algorithms 
to improve quality of care.  Further, these tools have been used to align preventive care delivery 
with community partners, consistent with the principles of the Chronic Care Model,15 to reliably 
and effectively improve patient outcomes and reduce downstream costs associated with 
uncoordinated and fragmented care.16-18
Our solution-oriented approach recognizes the opportunity to coordinate care across settings, 
using technology and workflow redesign solutions to coordinate care between community and 
health care settings to improve health outcomes for a high-risk population. Our coordinated care 

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model aims to support mothers and families to reduce early childhood obesity risk with 
preventative educational care plans and consistent messages as central components. Developing 
a system for coordinated care and communications for WIC and PCPs could be an effective and 
efficient way to decrease conflict in messaging, increase dose, and reinforce preventative 
education to optimize the effectiveness of early-life intervention on parenting behavior and child 
health outcomes.
Disease/Diagnosis: Data from the National Health and Nutrition Examination Survey 
demonstrate the need for early intervention to prevent obesity: 1 in 10 infants and toddlers are 
obese19 with those from lower socio-economic (SES) households at greater risk than their higher-
SES counterparts.20-26 Pennsylvania is 1 of 3 states to demonstrate significant increase in obesity 
rates among low-income preschoolers (aged 2-4 years) from 2008-2011.27 Further, Black/African 
American children showed divergence from white/Caucasian children in BMI growth trajectories 
by age 5 years even when controlling for known economic status, calling for greater attention to 
reduce health disparities.28 Excessive rapid weight gain during infancy also predicts obesity later 
in life,29-32 increasing the risk for health disparities.31, 33-35 Thus, infancy is a sensitive period when 
parents can and should intervene to establish healthy patterns that may last a lifetime to combat 
the obesity epidemic.36 These issues provide strong justification for focusing efforts on obesity 
prevention in low-income and racial/ethnic minority group mother/guardian-infant dyads, 
starting in early life in Pennsylvania.
Population to be Studied: Mother/guardians of newborn Geisinger patients who are also WIC 
eligible or participants.
Endpoints: Process outcomes include consistent messaging, patient engagement and satisfaction, 
maternal knowledge, attitude, self-efficacy, and maternal and child behavior; the primary impact 
outcome is rate of infant weight gain.
Significance: This study will generate data demonstrating that a coordinated care model between 
community and health care settings is an effective strategy to positively impact maternal
and child health outcomes, specifically obesity prevention which is arguably the most significant 
health issue facing millions of children with lifelong health, social, and economic effects. In 
addition, we will demonstrate that an adapted responsive parenting intervention that is tailored to 
the needs of each mother-infant dyad and includes coordinated care between health care 
providers and long-standing public health nutrition program will significantly improve diet 
quality and obesity prevention outcomes in children. Together, this evidence will support public 
health/policy efforts that focus on coordinated care models for exponential health benefits and 
strategies to reduce early pediatric obesity.

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4
HYPOTHESIS AND SPECIFIC AIMS
4.1
Hypothesis 
The project tests the hypothesis that an individually-tailored, responsive parenting obesity 
prevention intervention that coordinates care provided by WIC nutritionists and primary care 
providers will be more effective than usual care at 1) delivering consistent messages and 2) 
changing maternal and infant behavior to 3) reduce/prevent obesity in infants.
4.2
Specific Aim 1
Establish the efficacy of an individually-tailored behavioral intervention designed to prevent 
overweight at age 1 by providing coordinated, personalized care on responsive parenting across 
multiple settings.
4.3
Specific Aim 2
Conduct mediation analyses to improve understanding of how the intervention components, 
parent factors, and child behaviors influence rapid weight gain and to explain differential 
responses to our responsive parenting intervention that coordinates care across settings (WIC 
clinics, PCP).
5
PRELIMINARY DATA 
The proposed research was guided by the social cognitive theory37, 38 and uses the responsive 
parenting framework39-41 to increase parenting self-efficacy and prevent excessive weight gain in 
infancy. It is well evidenced that parents play an integral role in shaping children’s lifestyle 
behaviors.42 Responsive parenting, which involves prompt, contingent and appropriate interaction 
with the child, has been associated with desirable outcomes ranging from cognitive and 
psychosocial development to protection from disease and mortality.41, 43 For example, maternal 
responsiveness in early childhood has been associated with social competence, fewer behavioral 
problems,44 increased intelligence and cognitive growth.45 In a randomized controlled trial that 
taught first time mothers how to parent responsively, infants in the intervention had lower weight 
status at 1year when compared to control participants.46 These infants also slept longer, had 
higher levels of emotional self-regulation, and had mothers who were more responsive and 
reported higher parenting competence.46-48 In addition, preliminary data reveal that the responsive 
parenting intervention successfully prevented excessive rapid weight gain during the first 6 
months of life for both predominately breastfeeding and formula feeding mothers. However, 
these studies were conducted in a predominately white, affluent, low-risk sample. In the 
proposed study, we will supplement the HALF curriculum developed by the AAP, with our 
responsive parenting curriculum, following cultural sensitivity refinements, and test the efficacy 
of this intervention in a coordinated care model, targeting low-income families and families from 
racial/ethnic minority groups.

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6
STUDY DESIGN
6.1
Description
This prospective study will have two sequential phases 1) observational study; 2) interventional 
randomized controlled trial.  In phase 2, qualifying participants will be randomized 1:1 to receive 
either Treatment A or Treatment B. 
6.2
Study Population
6.2.1
Approximate Number of Subjects
Approximately 715 Geisinger subjects will participate in this study, 15 mother/guardian-infant 
pairs will participate in the observational phase and a total of 350 mother/guardian-infant pairs 
will participate in the RCT phase. The study team has accounted for participant drop-out by 
planning to enroll 350 Geisinger subjects, recognizing that a to meet power calculations a total of 
15 observational control dyads and 350 intervention/control dyads are needed. Mother/guardian-
infant pairs of infants that have a Geisinger primary care provider in the Geisinger Pediatric 
Service Line and who participate or are eligible and plan to participate in WIC will be enrolled in 
a single phase of the study.  Pregnant women who are eligible for or participate in WIC who also 
intend to have their newborn receive care from a Geisinger primary care provider in the 
Geisinger Pediatric Service Line will be enrolled in a single phase of the study.
6.2.2
Inclusion Criteria
Mother/guardian-infant pairs of infants that have a Geisinger primary care provider in the 
Geisinger Pediatric Service Line and who participate or are eligible and plan to participate in 
WIC will be enrolled in a single phase of the study.  Inclusion criteria:   

Parent of child between the ages of birth up to 6 months of age, preferably the mother. If 
mother is not available, then father/guardian can be enrolled.

Child must be patient of Geisinger Health System primary care provider in the Pediatric 
Service Line. (Phase 2 only: child must be a patient Partners in Pediatrics, Geisinger 
Health System primary care provider in the Pediatric Service Line)

Mother is English speaking.

Child must be eligible for WIC Program in Pennsylvania. (Phase 2 only: child must be 
eligible for WIC Program in Luzerne County, Pennsylvania). 

Infant birth weight >2500 grams.

Infant gestational age >37 weeks.

Infant is a singleton birth.

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Pregnant women (>27 weeks gestation) who are eligible for or participate in WIC who also 
intend to have their newborn receive care from a Geisinger primary care provider in the 
Geisinger Pediatric Service Line will be enrolled in a single phase of the study.  Inclusion 
criteria:   

Mother is English speaking.

Mother must be eligible for WIC Program in Luzerne County, Pennsylvania. 

Post-delivery, the infant birth weight >2500 grams.

Post-delivery, the infant gestational age >37 weeks.

Post-delivery, the infant is a singleton birth.
6.2.3
Exclusion Criteria
Exclusion criteria include:   

Mother/guardian is planning to leave the county where she was enrolled within 6-9 
months.

Mother/guardian is less than 18 years of age.

Mother is older than 55 years of age.

Infant death.

Infant is greater than 6 months of age.

Mother/guardian does not have a working telephone or way to communicate with study 
staff.

Cognitively impaired adults (determined subjectively by recruiting research staff, if 
parent is unable to answer verbal questions from research staff).

Mother has condition that would affect postpartum care or her ability to care for her 
newborn [e.g., narcotic drug use: heroin, cocaine, meth, pain pills, etc.], or major 
depressive disorder.

Mother did not receive prenatal care from, nor did she deliver at, Geisinger, but she does 
screen positive for major depressive disorder via the following process: 
o
Study staff administers PHQ2 questionnaire and mother scores as high risk (>4), 
subsequently study staff administers full PHQ9 questionnaire.  
o
In the event that the mother scores >10, the study staff will contact Geisinger 
Psychologist (O’Dell) who will call the mother within 24 hours and, if suicide risk 
is indicated, will keep the mother on the line while 911 services are contacted. 
o
In the event that the mother scores <10 on the PHQ9, the study staff will proceed 
with enrolling the mother into the study and mail to the mother a list of behavioral 
health services.  

Infant will be adopted. 

Infant has a congenital anomaly or neonatal condition that significantly affects feeding 
and/or growth (e.g., cleft palate, complex congenital heart disease, etc.) 

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6.3
Recruitment
Phase One: Observational Study
Trained research staff will visit Geisinger Medical Center (GMC) and Geisinger Wyoming 
Valley (GMC) hospitals each weekday, Monday-Friday, to identify mothers who have delivered 
infants in those facilities within the previous 24 hours.  A Partial Waiver of Authorization for 
Recruitment is requested to review the mother and newborn electronic medical record for initial 
eligibility screening.  Pre-screening items are listed in Attachment 2 along with the recruitment 
script that research staff will use when they visit potentially eligible mothers of newborns, 
discuss the study, and ask the mother some brief screening questions about if she and her infant 
are participating in WIC, or if they are eligible to receive WIC benefits, and to learn of the 
mothers intended clinic for pediatric care for the newborn child.  For those potential subjects 
who delivered on Friday or Saturday and may have been missed at the hospital, study staff will 
also generate patient lists each week for eligible children who will be receiving well child care at 
PSL clinics, to identify potential participants who are scheduled for a well child visit, and contact 
will be made by a research staff member at that clinic prior to the infants well child visit. Only 
study staff will have access to the patient list; only approved information that is necessary to 
determine if the mother/infant dyad is eligible for the study will be extracted from electronic 
medical records.
Phase Two: Randomized Controlled Trial
The recruitment process for Phase Two is the same as Phase One with the exception of adding 
inclusion criteria, as indicated in section 6.2.2.  Additionally, a flyer approved by Geisinger 
Corporate Communications will be distributed via social media and in WIC clinics to allow 
potential participants to opt-in to recruitment by providing their contact information to the study 
team.  Study staff will contact potential participants for eligibility screening. 
6.4
Study Duration
6.4.1
Approximate Duration of Subject Participation
Subjects will participate in the study for approximately 30 minutes per survey packet and there 
are 4 sets of survey packets for approximately 2 hours of participant time. 
6.4.2
Approximate Duration of Study
Phase One: Observational Study

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Phase One, Observational Study will be completed in approximately 11 months due to rolling 
recruitment.  The end of the study is marked by the last survey packet at 7 months.  
Phase Two: Randomized Controlled Trial
Phase Two, Randomized Controlled Trial will be completed in approximately 18 months due to 
rolling recruitment.  The end of the study is marked by the last survey packet at 7 months. Study 
participants who are enrolled at 28 weeks gestation may be in the study for an additional 2 
months. 
6.5
Procedures
Phase One: Observational Study
Potential participants will be approached by a trained IRB-approved research assistant during 
their stay at GMC or GWV labor and delivery to inquire if the patient and their infant would be 
interested in enrolling in the research project. The research assistant will explain the study in-
depth to the patient to ensure they understand the scope of the project. In addition, the patient 
will given a packet containing an information sheet which explains the contents of the study 
packet, two copies of the consent form of which one will be signed and kept by the study team 
and the other the patient will sign and take home, a flyer outlining the WIC program and how to 
enroll, and information regarding signing up for MyGeisinger to assist in monitoring their child’s 
care. Should the patient opt to sign-up for MyGeisinger during their stay in Labor and Delivery, 
each research assistant will be equipped with a Geisinger iPad on which the RA can enroll the 
patient in the MyGeisinger system.
Enrolled participants will be asked their preference for receiving survey packets, either by United 
States Postal Service or an emailed link to an electronic survey system, REDCap.  Participant 
preference for hard versus electronic survey packets, respectively, will be obtained after consent 
and during the enrollment process.  Participants completing survey packets electronically will be 
directed to the Pennsylvania State University’s REDCap.  Hard copy survey packets will be 
mailed to Dr. Savage Williams, Penn State University.  Participants will complete an enrollment 
packet (Attachment 3)  during the initial screening and recruitment into the research study 
followed by survey packets at 2 months (Attachment 4), 5 months (Attachment 5), and 7 months 
(Attachment 6), as well as a survey regarding patient perception of coordination of care and 
personalized care, corresponding with duration of study participation. Each mailed survey packet 
will be accompanied by a cover letter instructing the parent to return the survey using the pre-
paid stamped envelope.  If the mother/guardian is unable to complete the survey in the hospital, 
the survey packet will be distributed, per participant preference, and returned within one week. 
Parents that complete the 2, 5 and 7 month survey packets will receive a $50 gift card for their 

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time. Parents will be sent a thank you letter accompanying the gift card to recognize their time 
spent completing the study surveys.  If the parent completes all survey packets at each time 
points indicated above, they will receive an additional $50 gift card to thank them for completing 
all study surveys.
Mother/guardian-infant dyads will attend pediatric well child visits, per standard of care, and 
WIC visits in a normal, naturalistic fashion.  Pediatric participant data will be extracted from 
their electronic health records and WIC records to document visit frequency, physical exam, and 
feeding or nutrition-related metrics. To lessen the burden upon mother of the pediatric patient, 
the study will extract parent enrollment measures that are currently collected in the electronic 
medical record at Geisinger. These measures will not include any PHI elements. The data 
extracted as part of the research study will include anthropometric measures such as height and 
weight. These measures were originally included in the enrollment packet as questionnaires, 
however, due to sensitive time for the mother and to reduce burden this information will be 
extracted from the EHR. There will not be coordination of these data between WIC and 
Geisinger PCPs during the observational study.  Participants will know that they are enrolled in 
the observational study but PCPs and WIC will be blind to their participation in the study. 
Per requests by Geisinger Women’s Health, study flyers will be hung in Women’s Health as a 
means to make potential participants aware that they may be asked to enroll in the study during 
their time in Labor and Delivery.
Phase Two: Randomized Controlled Trial
Procedures for Phase Two, Randomized Controlled Trial are the same as those for Phase One, 
Observational Study except that: 1) participants will be randomized to the treatment or control 
groups following participant consent/authorization/agreement.  An electronic program will be 
used to randomly assign patients to a group;  2) Pediatric participant data will be extracted from 
their electronic health records and WIC records to document visit frequency, physical exam, and 
feeding or nutrition-related metrics 3) Pediatric participants will be given educational materials 
based on upon their recruitment in the intervention/control arm.  These data will be electronically 
shared between WIC and Geisinger PCPs for the purpose of coordinating care for a 6 month 
intervention period and then disabled. Geisinger and WIC will share agreed upon data elements 
using a secure, File Transport Portal (FTP) site daily. Verification of shared participants between 
GHS and WIC will be authenticated with mother’s name, mother’s telephone number, date of 
birth, date of delivery, infant name, and birth date. To increase the likelihood of intervention arm 
participants enrolling in WIC, the mother’s telephone number will be transferred. The telephone 
number will be used by WIC to contact the participant and schedule an initial visit with a WIC 
nutritionist in Luzerne County. Following authentication, random participant IDs will be 
assigned to protect confidentiality;  and 3) Participants will be blind to group assignment, 
however PCPs and WIC will know group assignment because shared data for participants in the 
treatment group will be electronically displayed in the EHR at Geisinger and the QuikWIC 

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system at WIC for the purpose of coordinating care. A trained research assistant or project 
coordinator will access the participating patient’s medical record for the purposes of creating a 
documentation encounter in which the data collected from the QuikWIC system will entered. 
This data will be stored in EPIC flowsheet rows. The data will then be displayed for the provider 
in the progress note to assist in the coordination of care. All participants will complete an 
informed consent form which will include PHI elements being shared. Throughout enrollment in 
the study, intervention participants will receive a phone call from a trained Geisinger nurse to 
assist with providing educational guidance for their child (feeding, sleep, tummy time, etc.) We 
anticipate this call will last around 10 minutes.  To best serve the pediatric patient population 
enrolled in this RCT, the study team will be providing both intervention and control participants 
with educational materials that were developed in part by the AAP, but also vetted studies which 
were conducted at The Pennsylvania State University. Educational materials will be distributed 
to WIC for use during nutrition visits, as well as, provided during enrollment into the study and 
sent via mail. The purpose of the educational materials is to provide added value to parents 
enrolled in the study and assist them in providing care for their infant. To ensure participants are 
able to attend their scheduled WIC nutritionist appointments, the study team will provide a small 
business-size colored card at enrollment with the WIC contact information to reschedule their 
appointments if the need arises. The reschedule information is as follows: 1-570-826-1777 or 
Toll free- 1-800-367-6347 Extension 244. In addition, during the 7 month enrollment period, the 
EHL survey (standard of care) will not fire for control participants, this will be sent via mail 
included in the 2,5,7 month survey packets. Post-enrollment, the study team will also mail a 
postcard to participants thanking them for participating in the study and a short high level 
overview of their participation. The post-card will also serve as a reminder that the participant 
will be receiving surveys at 3 time points throughout their enrollment. For intervention patients 
that do not complete the EHL screener at their regularly scheduled WCV, the study team will 
send a mailed copy of the EHL survey to the home for the parent to complete. To ensure that 
intervention participants are presented the opportunity to complete the EHL screener, the study 
team will include a paper copy of the screener in the participant’s enrollment packet. The survey 
will only be included should the participant choose not to sign-up for MyGeisinger and prefer to 
complete the survey on paper Enrollment in MyGeisinger is not an inclusion/exclusion criteria. 
For participants that are given the EHL screener at enrollment, once the screener is completed at 
home, the participant will be asked if they could please bring the survey with them to their initial 
WIC visit. The screener will be used to better inform the WIC nutritionist visit and does not 
contain PHI. The screener will then be collected by the WIC nutritionist and transferred 
electronically back to Geisinger study staff. This data is essential in comparing intervention and 
control participants. To ensure that our participants are able to receive their survey packets in a 
timely manner, whether by mail or email as indicated by the participant, a study staff member 
will contact the participant via phone call. This phone call will consist of confirmation of receipt 
of survey, and to allow the participant to ask any questions that have arisen through the process 
of reading the questionnaire and answering the questions to the best of their ability. If the study 
team is unable to reach the participant via phone, a voicemail will be left asking the participant to 
call the study team back if they did not receive their survey. Participants will also receive an 

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email or mailed reminder which includes the survey to complete should it not be returned within 
a timely manner. The mailed reminder will be sent to the participant with a self-addressed 
stamped envelope in which to return the survey. The participant is not required to return the re-
mailed survey if they have completed the initial copy which was sent. Once the survey is 
received from the participant, a $50 will be sent thanking them for their time and participation. 
Information collected in the study surveys is time sensitive and directly related to the child’s age 
at the 2,5,7 month time periods, thus it is important to receive the data in a timely manner. No 
data will be shared between WIC or PSU (as indicated in the above observational study) until an 
informed consent form is completed and the participant understands their role in the study and 
what will be shared.
The study team also plans pursue recruitment of eligible pediatric patients at newborn visits in 
participating Partners in Pediatrics clinics. Due to the nature of recruitment in a labor and 
delivery environment, it is not always possible to capture all eligible participants, which 
introduces bias, and more than a third of the potential participants pre-screened are ineligible due 
to a non-participating pediatrician, and nearly a third of potential participants that receive direct 
recruitment are also not eligible due to a non-participating pediatrician. By instituting 
recruitment prior to delivery and at the newborn visit with participating pediatricians, the study 
team hopes to equitably capture the largest eligible population. To achieve this goal, the study 
team will provide WIC and Partners in Pediatrics sites with a study flyer, WIC income eligibility 
flyer, and a short information sheet to provide to eligible participants. The approved prenatal 
recruitment flyer will also be distributed via social media. A data analyst in the Obesity Institute 
will pull a recruitment list that screens all Geisinger patient-participants for eligibility and 
provide this to the study team daily. A research assistant on the project will then screen the 
patient’s medical record via chart review to ensure all inclusion criteria are met and there are no 
additional exclusions (adoption, drug use, etc.). For patients screened as eligible, the study team 
would contact the regional director for pediatrics who would notify clinic staff to distribute 
materials at the 3-5-day newborn visit. For prenatal recruitment of non-Geisinger patients, 
interested participants will contact the study team.  Afterwards, the study team will follow-up via 
phone (mobile or home) or email or mail to arrange to or discuss the study with the potential 
participant. If interested, the study team will then send two copies of the consent form, the 
enrollment survey, a pre-paid stamped envelope, and instructions on how to complete and return 
the consent form and survey. During the course of the phone call, should the participant elect to 
complete the enrollment survey via over the phone, the study staff member will record the survey 
responses utilizing the RedCap system which stores all participant survey results.  In addition, 
the participant may also elect to receive the consent form and survey electronically via RedCap, 
during their conversation with the research assistant. If the participant chooses to receive the e-
consent, an electronic version of the WEE consent form and enrollment survey will be send to 
the participant’s email that they provide on the phone. The consent will be emailed and stored 
securely in the RedCap system, which is only accessible to approved GHS study team members. 
If the participant does not complete the e-consent in a timely fashion, the RedCap system will 
send automated reminders. Once the participant returns the consent form or e-consent form and 

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completed survey, they will be enrolled into the study and care will resume as noted above based 
upon whether the participant is randomized to the intervention or control arm.
To ensure providers are effectively utilizing the coordination of care display module that was 
built within EPIC, the study team plans to conduct physician shadowing at participating clinics 
in Luzerne County. This will include shadowing providers, ensuring the IT module is working as 
intended, and to provide any oversight/problem solving that is necessary. The study team will 
also use this opportunity to discuss physician satisfaction with the end product and 
improvements/modifications that should be made to improve efficiency and assist with current 
workloads.
6.5.1
Study Time and Events Table  
Phase One: Observational Study
Study Procedures
Day 1-8
Month 2
Month 5
Month 7
Study Interval
Screening/Enrollment
Active phase
Informed consent
X
Demographics
X
Medical history
X
Weight
X
X
X
X
Physical examination
X
X
X
X
Vital signs
X
X
X
X
Standard of care EHL questionnaire
X
X
X
X
Study questionnaires
X
X
X
X
WIC information
X
X
X
Phase Two: Randomized Controlled Trial
Study time table and events for Phase Two, Randomized Controlled Trial are the same as Phase 
One, Observational Study except:  Day 1-8 Geisinger and WIC will verify that the participant is 
a Geisinger patient who provided informed consent to participate in the study and the infant is 
enrolled as a WIC participant.  After the participant is authenticated as receiving care at both 
Geisinger and WIC, data sharing will be enabled between Geisinger and WIC.  Bi-directional 
data sharing between Geisinger and WIC will continue for the 6 month intervention (last data 
collection point at 7 months). 

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6.5.2
Study Flow Diagram
Figure 6.5.2-1:  Phase One Observational Study Flow Diagram  
WIC data extraction
EHR data extraction 
Enrollment Survey Packet Completed
Orientation Meeting and Informed Consent/Assent
Electronic Health Record (EHR) Screening
Invitation to Participate by Trained Research Staff 
Observation of Care (n = 15)
Women, Infants and Children 
Program Appointments (Appt.)
Week 1: Appt. 1
Month 2: Appt. 2
Month 6: Appt. 3 
Month 7: Visit 4 with EHL & survey packet 
Month 5: Visit 3 with EHL & survey packet
Month 2: Visit 2 with EHL & survey packet
Week 1: Visit 1
Geisinger Pediatric Service Line 
Well Child Visits (Visit)

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Figure 6.5.2-2:  Phase Two Randomized Controlled Trial Flow Diagram  
Primary Endpoints
The primary endpoint will be excessive rapid weight gain, or weight-for-age z-scores, at post-
intervention. The phase one observational study provides the naïve condition of weight-for-age 
z-scores that will be compared to treatment group in the randomized controlled trial.  A 0.67 
difference in weight-for-age z-scores represents the distance between major centile lines 
displayed on infant growth charts.  This difference is clinically meaningful, and upward 
percentile crossing of this magnitude has been the operational definition for rapid weight gain. 
GHS EHR and WIC data extraction 
Enrollment Survey Packet Completed
Orientation Meeting and Informed Consent/Assent
Electronic Health Record (EHR) Screening
Invitation to Participate by Trained Research Staff 
Randomization to Group (n = 290)
Usual Care
(control) (n = 145)
Month 6: Visit 4 @ GHS with EHL; WIC 
visit; data shared and displayed 
Month 5: Visit 3 @ GHS with EHL; WIC 
visit; data shared & displayed; survey packet
Month 2: Visit 2 @ GHS with EHL; WIC 
visit; data shared & displayed; survey packet
Week 1: Visit 1 at GHS and WIC; 
authenticate participant
Coordinated Care
(treatment) (n = 145)
Month 7: survey packet
Week 1: Visit 1 at GHS and WIC; 
authenticate participant
Month 2: Visit 2 @ GHS without EHL; WIC visit; 
data shared/not displayed; survey packet
Month 5: Visit 3 @ GHS without EHL; WIC visit; 
data shared/not displayed; survey packet
Month 6: Visit 4 @ GHS without EHL;WIC 
visit; data shared/not displayed 
Month 7: survey packet
GHS EHR and WIC data extraction 

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Secondary Endpoints
Secondary endpoints include consistent messaging; attitudes, beliefs, and knowledge; self-
efficacy; and measures identified as “individual characteristics,” “responsive parenting,” and 
“infant intake” in Figure 1 boxes.  
Footnote:  Infant growth measures include rapid weight gain measured by change in weight-for-age z-
score. 
6.6
Statistics
The statistical analyses will be performed at the Pennsylvania State University by Dr. Savage 
Williams and Mrs. Michele Marini.  
6.6.1
Statistical Analysis Plan
Subscales for survey instruments will be treated as parametric data, and repeated analysis of 
variance will be used to assess the effects of the future intervention on changes of these 
composite outcomes and changes in child growth.  All models considered will include relevant 
time-varying and stable-covariates.  Covariates to be considered in refining the analyses can be 
grouped into categories that include maternal biologic variables, socioeconomic and 
demographic variables, infant behavioral variables, and parental behavioral variables.  A linear 
mixed-effects model, a generalization of regression, will be used to examine the relationship 
between weight-for-age z-score and study group.  The moderating effect of maternal mental 
health and child temperament on intervention efficacy will be tested.  Continuous secondary 
parental and infant behavior outcomes assessed at multiple time points, including sleep duration, 
feed duration, fussing and crying duration, feeding practices and attitudes and parenting sense of 
competence, will be analyzed using appropriate time series methods.  These methods will allow 
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the effects of the model, namely study group, initial feeding mode intent, and their interaction.  
These secondary outcomes will be included as moderators in analyses of primary growth 
outcomes.  The moderator hypothesis represents the interaction between these variables and the 
main effects of the model while including each of these variables as additional main effects. We 
will also test whether these secondary variables function as mediators; that is are these variables 
predicted by the effects of the model and, in turn, predict the primary outcomes. Using path 
modeling to test these models, we will be able to determine the direction of influence among the 
variables in the model. 
6.6.2
Statistical Power and Sample Size Considerations
We have powered the study to detect a 0.67 difference in weight-for-age z-scores between the 
observational and future intervention groups.  To detect this difference with 90% power and a 
5% Type I error rate, 276 participants are required.  This includes an anticipated 30% loss to 
dropout.  This study is also powered on food to soothe a distressed child and uses nominal power 
= 0.8 and alpha = 0.05.  If we assume that we can change 15% of mothers in the future treatment 
group to reduce their use of food to sooth as compared to mothers in the observational study, 
assume a constant variance of 1 and a retention rate of 67% during the study period, we will need 
to recruit 300 pediatric participants.  We have experienced a 31-33% drop-out rate in previous 
studies of mother/guardian-infant dyads for longer than 3 months duration, and so assume a 
similar drop-out for this study. 
6.7
Data Management
6.7.1
Data Collection and Storage
Primary data will be collected by trained study staff from patient electronic health records, WIC 
records, and survey questionnaires. Survey data will be maintained at the Pennsylvania State 
University. However, due to the sensitive nature of the PHQ-2 and PHQ-9, these data will only 
be collected and stored securely at Geisinger. No responses to the PHQ-2/PHQ-9 will be sent 
outside of Geisinger.  WIC data will be collected electronically from the Pennsylvania WIC 
Program and transferred using an encrypted, data transfer portal. Patient data extracted from the 
electronic health record will be maintained in a data base created by a Geisinger data analyst; 
trained study staff will enter data into the database; and these data will be stored on a password-
secured electronic server. Protected health information (PHI) will be collected; these data will be 
stored by study identification (ID) and not be related to patient name or medical record number 
(MRN). The study ID will be assigned at study entry.  Participant name will be connect to the 
study ID through a numbered list that will kept separate and apart from medical record 
information.  This list will be stored in a locked, secure filing cabinet in a locked office at 
Geisinger Health System. Participant names will not appear on any research records or used in 
research publications. The principal investigator will have the key to the locked office and 
locked cabinet.  

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6.7.2
Records Retention
Data will be kept for an indefinite period of time for IRB-approved use in future studies.
7
PROTECTION OF HUMAN SUBJECTS
7.1
Informed Consent
Phase One: Observational Study
The investigator will provide for the protection of the subjects by following all applicable 
regulations.  The informed consent form, (found in Attachment 2), is submitted to the IRB for 
review and approval.  
The following conditions apply to obtaining informed consent: 

A waiver of authorization is requested for pre-screening of potential participants
Before any procedures specified in this protocol are performed, a subject must:

Be informed of all pertinent aspects of the study and all elements of informed consent. 

Be given time to ask questions and time to consider the decision to participate.

Voluntarily agree to participate in the study. 

Sign and date an IRB-approved informed consent form.
Phase Two: Randomized Controlled Trial
The procedures for informed consent for Phase Two, Randomized Controlled Trial, are the same 
as those described for Phase One, Observational Study except that data sharing and care 
coordination are emphasized (found in Attachment 12).
7.2
Protection of Human Subjects Against Risks
During the pre-screening process, the mother’s electronic medical record will be reviewed for 
eligibility prior to initial contact.  If the mother has documented major morbidities and/or pre-
existing conditions that would affect postpartum care or her ability to care for her newborn (e.g., 
narcotic drug use; heroin, cocaine, meth, pain pills, etc., chemotherapy, uncontrolled multiple 
sclerosis, or uncontrolled depression), then the mother will not be eligible for the study.  These 
data will be used for pre-screening only and no identifiable information will be retained.  The 

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study staff will take the following precautions to minimize risks related to loss of confidentiality: 
all data will be stored on a secure server only accessible to approved study staff via password-
protected portable computers during recruitment and consent.  Pediatric patients in the study will 
be assigned a study number independent of their MRN; this number will also be used to uniquely 
identify the mother/guardian.  PHI obtained for recruitment will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, 
or for other permitted uses and disclosures according to federal regulations. 
No identifiers will be retained in the data that is analyzed for intervention effects.  All MRNs and 
any personal information will be removed prior to analysis.  A sequential study ID will be used 
for each enrolled participant by a study staff member and there will be a master list of study ID 
numbers and participant names and addresses (that will not be stored with any collected data), in 
order to pay participants for the time involved with this research project.  For research purposes, 
there is no need to know the participant name or any person-identified health information.  
Primary data will be collected by trained study staff from patient electronic health records, WIC 
records, and survey questionnaires. Survey data will be maintained at the Pennsylvania State 
University.  WIC data will be collected electronically from the Pennsylvania WIC Program and 
transferred using an encrypted, data transfer portal. Patient data extracted from the electronic 
health record will be maintained in a data base created by a Geisinger data analyst; trained study 
staff will enter data into the database; and these data will be stored on a password-secured 
electronic server. Protected health information (PHI) will be collected; these data will be stored 
by study identification (ID) and not be related to patient name or medical record number (MRN). 
The study ID will be assigned at study entry.  Participant name will be connect to the study ID 
through a numbered list that will kept separate and apart from medical record information.  This 
list will be stored in a locked, secure filing cabinet in a locked office at Geisinger Health System 
for a period of 5 years, after which time the identification list will be destroyed.  Participant 
names will not appear on any research records or used in research publications. The principal 
investigator will have the key to the locked office and locked cabinet.  
7.3
Data Monitoring Plan 

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This study presents no more than minimal risk for participants as the probability and magnitude 
of harm or discomfort anticipated in the research is not greater in and of themselves than those 
ordinarily encountered during daily life or the performance of routine well child visits.  

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8
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9
ATTACHMENTS
9.1
Attachment 1: EHL Screening Tool 
9.2
Attachment 2: Pre-Screening and Recruitment Packet
9.3
Attachment 3: Enrollment Survey Packet
9.4
Attachment 4: 2 Month Survey Packet
9.5
Attachment 5: 5 Month Survey Packet
9.6
Attachment 6: 7 Month Survey Packet
9.7
Attachment 7: Coordination of Care Measures
9.8
Attachment 8: WIC Brochure
9.9
Attachment 9: MyGeisinger Enrollment Instructions
9.10 Attachment 10: WEE Information Sheet
9.11 Attachment 11: Patient Involvement in Care Questionnaire
9.12 Attachment 12: RCT Informed Consent