Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0
Phase: NA
Conditions: Overweight or Obesity, Pregnancy
Sponsor: University of Kansas Medical Center

 
 DPP Feasibility Study of Breastfeeding 
 
1 
 
 
 
 
 
 
 
 
Diabetes Prevention Program Feasibility Study of Breastfeeding 
Electronic Monitoring of Mom's Schedule 2.0 
 
Protocol ID: RKS2018350 
NIGMS Award #: 3P20GM144269-02S2 
NCT ID: not yet assigned 
 
Principal Investigator: Lisette Jacobson, PhD, MPA, MA 
 
Version: February 7, 2024 
  
 
 
 

 
 DPP Feasibility Study of Breastfeeding 
 
2 
 
Section I. Purpose, Background and Rationale 
 
A. Specific Aims 
In the proposed randomized controlled trial, we seek to determine the feasibility and 
efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese 
women to be followed during pregnancy through 3 months postpartum.  Our trial will have two 
study arms: DPP plus breastfeeding (Tx1); and Usual Care (Tx2). Specific aims are: 
 
Aim 1: Quantify interest in use of the DPP-lactation support app among target population. 
To accomplish this, we will: (1) measure research engagement including rates of screening, 
recruitment, and retention among users, especially rural and racially/ethnically diverse women; 
(2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-
depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence 
via tracking/measuring use of the app.  
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among 
target population.  To accomplish this, we will measure pre-pregnancy weight, weight at study 
entry, weight immediately prior to and after delivery, and weight at specific postpartum time 
points.  Lactation and infant feeding practices will be measured at similar postpartum time 
points. 
 
B. Background and Significance 
 
Between 1987 and 2020, U.S. pregnancy-related mortality tripled, from 7.21 to 23.82 
maternal deaths per 100,000 live births with women of color, low-income and rural women at 
particularly increased risk of pregnancy-related death.3,4  Increasing trends in obesity contribute 
to severe maternal morbidity and mortality.  In 2019, nearly 3 in 10 U.S. women had pre-
pregnancy obesity (PPOB).5 
PPOB is a major risk factor for gestational diabetes mellitus (GDM) affecting 7-9% of 
pregnant women, particularly those with advanced maternal age, low socio-economic status, and 
women who self-identify as being non-White.6  Women with GDM and comorbid conditions 
such as PPOB experience adverse pregnancy outcomes7-9 including pre-eclampsia,9-11 emergency 
cesarean section,10,12 maternal prenatal depressive symptoms,13 pregnancy hyperglycemia,13 and 
reduced lactation.14  Further, women with GDM have a seven-fold risk of developing type 2 
diabetes mellitus (T2DM) later in life compared to women without GDM.15,16 
Lactation is a critical element of postpartum care management.  Women who lactate have 
a lower incidence of T2DM17-20 and reduced postpartum weight.21-23  To optimize these benefits, 
the World Health Organization (WHO) 24 and the American Academy of Pediatrics (AAP)25,26 
recommend exclusive breastfeeding for the first six months of life along with introduction of 
complementary foods at six months while continuing human milk for up to two years and 
beyond.  About 83% of U.S. women attempt lactation, but only 56% continue to provide human 
milk with formula supplementation at six months and only 25% provide human milk exclusively 
at six months.27 

 
 DPP Feasibility Study of Breastfeeding 
 
3 
 
Implementation of lifestyle change programs such as the national Diabetes Prevention 
Program (DPP) can reverse negative effects from PPOB28-31 and reduce postpartum weight.32,33 
The DPP, through counseling on effective diet, exercise, and behavior modification, is associated 
with a reduced risk of developing T2DM by 58%34,35 and is shown to be effective for preventing 
diabetes in women with a history of GDM.36  Yet, access to evidence-based weight management 
programs that include lactation support remain limited.  We posit that a significant number of 
medically underserved women will elect to participate in DPP-like interventions that include 
lactation support, if available. Clearly, technology-assisted DPP-like interventions show 
clinically meaningful weight loss.37,38  Extended with lactation support, these programs have still 
unrealized potential to expand access to medically underserved communities. 
To date, there are no studies that have coupled the DPP with bi-directional digital 
lactation support delivered to pregnant, medically underserved populations with overweight or 
obesity.  The proposed study seeks to narrow the gap in knowledge by implementing a DPP-
based intervention coupled with bi-directional lactation support for pregnant women at risk for 
pregnancy-related morbidity and mortality through an easily accessible mobile health (mHealth) 
application (app).  
 
C. Preliminary Studies 
I led and completed two pilot studies in southwest rural Kansas: (1) a health assessment 
of the obstetrical population (completed in April 2015), and (2) a follow-up focus group study 
with the same population (completed in May 2016).  The purpose of the assessment was to learn 
about the health behaviors of rural pregnant women.  Two local hospitals and one federally 
qualified rural health center participated in the assessment.  Our sample consisted of 177 rural 
pregnant women.  Key findings indicated that the majority of women were Hispanic (50.3%), 
18-25 years old (48.6%), high school educated (51.2%) , WIC enrolled (51.7%), and earned < 
$25,000/year (54.2%).39  The majority were overweight (28.1%) or obese (26.2%) prior to 
pregnancy.39  Additionally, the majority engaged in no daily exercise (72.6%) and nearly one-
third (30.5%) reported having an immediate family member who was diagnosed or treated for 
diabetes or cardiovascular disease.39 
These results demonstrate significant diabetes risk factors during and after pregnancy.  
Subsequently, in follow-up to the assessment, I led and completed a focus group study to gain in-
depth information from this same population on what they would value in a health promotion 
program.  Findings indicated limited availability of programs that focus on exercise, diet, and 
breastfeeding support during and after pregnancy.  Further, I published three additional studies 
relevant to the proposed project.40-42  Each of these studies focused on health behaviors among 
urban versus rural WIC enrolled women in Kansas and helped our research team understand the 
prenatal and postnatal needs of at-risk populations in Kansas.   
The electronic Monitoring Of Mom’s Schedule 1.0 study (eMOMSTM) was a feasibility, 
three-arm, multi-center randomized controlled trial (NCT04021602) examining lifestyle changes 
modelled after the Diabetes Prevention Program (DPP) and lactation (LC) support alone, and in 
combination. eMOMS 1.0 was created to quantify intervention uptake, and measure weight and 

 
 DPP Feasibility Study of Breastfeeding 
 
4 
 
lactation duration.43  The intervention was delivered by a professionally trained certified health 
coach (HC) using Facebook. 
At baseline, participants averaged 13.0 (±2.5) weeks gestation, mean pre-pregnancy BMI 
of 29.7 (±3.0).  With 5,000 bootstrapped samples, mean weight retention from baseline to 6 
months postpartum was: 8.9 lbs. (3.6, 13.7) for DPP+LC+HC; 8.1 lbs. (-4.0, 21.7) for DPP+HC; 
and 16.5 lbs. (9.1, 25.5) for the health coaching only (HCO) group.  Mean lactation duration was: 
11.3 weeks (1.3, 21.2); 14.9 weeks (9.9, 20.0); and 16.7 weeks (9.4, 23.3) for each group 
respectively (our primary outcomes paper is currently under review with the Journal of Human 
Lactation and until this publication is finalized, study findings will remain preliminary).  
Between September 2019 and May 2021, 100 individuals were screened, 47 were 
eligible, and 35 were randomized resulting in a 35% enrollment rate. Of those, 26 completed the 
intervention resulting in a 74% retention rate.  Intervention completers were slightly older and 
entered the study earlier in pregnancy compared to non-completers.  Completers were more 
likely to be first-time mothers, resided in urban areas, had higher educational attainment, and 
were slightly more racially and ethnically diverse.  A majority of providers reported willingness 
to participate, believed the study aligned with their organization's mission, and were satisfied 
with using iPads for screening.  Lessons learned to guide recruitment success include use of: (1) 
designated research staff in combination with physician support; and (2) user-friendly 
technology to help mitigate time burden on physicians and their staff.44 
Additionally, feedback from study participants on their experiences was obtained. Of the 
26 individuals who completed the eMOMS 1.0 study, 24 consented to a semi-structured, 
telephone interview using open-ended questions.  Interviews were completed between October 
2020 and May 2021.  Data were analyzed using an exploratory, inductive thematic analysis.  
Participants' mean age was 27.5 (± 5.4) years and mean pre-pregnancy BMI was 29.5 kg/m(2) (± 
2.7).  The majority (71%) were non-Hispanic White and 54% had a high school education/some 
college.  Based on specific areas of inquiry, the following themes emerged: convenience of 
online program access using Facebook, importance of health coach's support and online 
interaction, positivity toward improving one's health, increased consciousness of health 
behaviors, diverse lactation educational needs, importance of educational materials on 
depression, and grief over the loss of birth expectations during COVID-19.45  In summary, study 
results show that lifestyle changes and health coaching positively impact postpartum weight 
retention and lactation duration.  
 
D. Rationale for Proposed Study 
Risk factors for diabetes are well documented.46-50  Maternal obesity in particular 
increases the risk of negative health outcomes for mother51-56 and child,57-62 including the 
propensity for women to retain excessive postpartum weight leading to obesity in subsequent 
pregnancies.63-66  Less is known about protective factors relevant to diabetes though evidence 
suggests that longer duration of breastfeeding among women with a history of GDM is 
associated with lower incidence of developing type 2 diabetes up to two years after 
pregnancy.19,20,67,68  Breastfeeding also appears to lower maternal postpartum weight21,69,70 and 
facilitates the resetting of maternal metabolism after pregnancy.71  The Diabetes Prevention 

 
 DPP Feasibility Study of Breastfeeding 
 
5 
 
Program (DPP) is associated with a reduced risk of developing diabetes by 58%72  and there is 
evidence to support the use of this efficacious program in reducing postpartum weight.32,33  
Despite these findings, no studies prior to eMOMS 1.0 have used a DPP-enhanced version 
delivered using an mHealth app that includes intensive breastfeeding counseling and support for 
overweight and obese women.  Given that overweight and obese women at risk for GDM are 
also less likely to start and continue breastfeeding,60,73-75 it is critical that interventions for 
reducing GDM risk also include breastfeeding support that is uniquely tailored to the needs of 
this population.  This is where the current proposal narrows the gap and contributes to the body 
of knowledge about reducing diabetes risk factors during and after pregnancy in an underserved 
population with scarce healthcare resources available.  
 
E. Impact of Proposed Study 
The proposed project will inform future intervention efforts that aim to reduce diabetes 
risk factors during and after pregnancy and to increase breastfeeding, thereby improving short- 
and long-term maternal and child health outcomes.  The immediate impact will be to reduce 
diabetes risk factors among a high-risk population and inform interventions aimed at reducing 
these risk factors and decreasing disproportionate morbidity.  Its ultimate potentially high public 
health impact is GDM and type 2 diabetes prevention among a racially and ethnically diverse, at-
risk population.   
This project’s impact is to provide strategies to improve human lactation and to reduce 
diabetes risk factors among women with overweight and obesity.  Together, we expect to have a 
positive impact on improving access and delivery of an efficacious weight management program 
to pregnant populations, thereby decreasing disproportionate maternal morbidity and mortality, 
which is of significant importance to the National Institutes of Health.  Our proposed research is 
expected to have a positive impact on improving access and delivery of efficacious weight 
management programs to pregnant populations using an mHealth application, thereby decreasing 
disproportionate maternal morbidity and mortality, which is of the highest priority to the Office 
of Research on Women’s Health and the National Institute of Child Health and Human 
Development.   
 
F. Justification for Project 
Risk factors for diabetes are well documented,46-50 but less is known about some factors 
that attenuate the risk for GDM.  Recent studies support the use of the Diabetes Prevention 
Program in reducing postpartum weight.32,33  Moreover, emerging research suggests that longer 
duration of breastfeeding among women with a history of GDM decreases the likelihood of 
developing type 2 diabetes within two years after pregnancy.19,20,67,68 However, no prior studies 
to eMOMS 1.0 have assessed the feasibility and efficacy of a DPP-based intervention that 
includes intensive breastfeeding counseling and support delivered using an mHealth app among 
racially and ethnically diverse reproductive-age rural women.  Rural pregnant women in 
particular have decreased access to healthy foods and fewer options to engage in physical 
activity.76-80  Furthermore, Hispanic women often supplement breastfeeding with formula, 
triggering decreased milk supply and early breastfeeding cessation.81-83  The proposed research is 

 
 DPP Feasibility Study of Breastfeeding 
 
6 
 
innovative because it represents a departure from what has been accomplished in the field thus 
far: We seek to implement a combined breastfeeding, DPP-based intervention delivered using an 
mHealth app and determine its feasibility and efficacy as well as its effect on metabolic outcomes 
among an at-risk population.  Through examination of postpartum weight, breastfeeding 
behavior, and metabolic markers, results of the proposed project will inform the development of 
interventions to reduce diabetes risk factors during and after pregnancy.  Furthermore, an 
efficacious approach toward promoting exercise, nutrition, and breastfeeding can be integrated 
into the continuum of healthcare services provided to racially and ethnically diverse, at-risk rural 
pregnant women. 
 
Section II. Research Plan and Design 
 
A. Study Design Overview 
 
Figure 1. Study Design 
This two-arm randomized 
controlled trial (RCT) will determine 
feasibility of the DPP mHealth app 
coupled with bi-directional lactation 
support, among a cohort of pregnant 
women with overweight and obesity (see 
Figure 1). Potential participants will be 
screened for inclusion/exclusion criteria. 
Upon recruitment during the 2nd or early 
3rd trimester, eligible participants will 
be randomly assigned to either DPP-
Lactation App (Tx1) or Usual Care 
(Tx2), and followed during pregnancy 
through 3 months postpartum. Usual 
care is described as obstetrical care that 
women with normal BMI receive and 
that is provided by the same provider. 
We will use a total sample of 50 
pregnant women prior to accounting for 
dropouts. To evaluate the intervention’s 
impact on the maternal-infant dyad, 
health indices will be monitored (see 
Table 4. Outcomes Measures, under 
Section III).  Information gathered by this feasibility RCT will be used to develop a full scale 
RCT to assess if the DPP-lactation mHealth app (1) reduces postpartum weight retention, and (2) 
increases duration of lactation.  
 

 
 DPP Feasibility Study of Breastfeeding 
 
7 
 
B. Duration of Study 
It is anticipated that after receiving Institutional Review Board (IRB) approval, 
recruitment will begin Spring of 2024 and will continue through early Summer of 2024.  We will 
recruit over a period of 3 months and the last follow-up with study participants will take place at 
3 months postpartum.  The trial will be completed over a 6 to 9-month period.  Data collection 
and preliminary data analysis will take place as the trial runs.  Final data analysis and 
dissemination of findings will take place following completion of the trial, during the final 
quarter of 2024 and/or first quarter of 2025.             
 
C. Number of Participants 
This IRB protocol pertains to the recruitment of eligible participants from one obstetrical 
clinic: Ascension Via Christi Hospitals Wichita, Inc.  The state of Kansas lends itself for this 
study because of its stable population evidenced by minimum population migration between 
April 1, 2010, and April 1, 2020, compared to other comparable rural states (i.e., Iowa, 
Nebraska, Oklahoma)].82  
Our Maternal-Fetal Medicine (MFM) specialist in Wichita, Dr. Michael Wolfe, sees a 
high volume of vulnerable patients with high-risk pregnancies, at an average of 123 patients per 
month, with an average pre-pregnancy BMI of 30.5 (personal communication, January 2022). In 
Wichita, 51% of its population is female, 17% is Hispanic followed by 10% non-Hispanic 
Black.83 Dr. Wolfe’s obstetrical clinic is affiliated with Ascension Via Christi Hospitals Wichita, 
Inc. located in Wichita, Kansas.  
Based on our previous work, our recruitment target of women with BMI ≥25 will involve 
15% non-Hispanic Black women, 25% Hispanic women, and 60% other race including non-
Hispanic Whites.  We anticipate meeting our recruitment goals through multiple approaches: (1) 
recommendations from physicians and staff; (2) social media; (3) targeted mailings; and (4) 
clinic posters and study brochures.  We will recruit over a period of 3 months, planning to 
randomize 3-4 participants each week.  Our goal is to randomize a total of 50 pregnant women 
(25 women in each study arm).  Given an attrition rate of 20%, this will leave us with 40 women 
total (20 women in each study arm).  
 
D. Subject Selection Criteria and Recruitment 
We will actively recruit pregnant patients from Via Christi Hospitals Wichita, Inc. Rural 
hospitals and other various hospitals will be made aware of the study and refer patients to the 
eMOMS website. A website has been created containing the same information as the one-page 
flyer and study brochure that will be approved by the Institutional Review Board.  We recruit 
participants into the study using two methods.    
First, women will see flyers and brochures in their physician offices and will voluntarily 
go to the website and recruit themselves into the study.  The website contains a link named “Do I 
qualify for eMOMS?” that interested women can use to recruit and screen themselves.  If an 
interested participant meets eligibility, wants to participate, has all her questions answered, and 
electronically consents to participate using REDCap, then a study team member will contact her.     
 

 
 DPP Feasibility Study of Breastfeeding 
 
8 
 
Second, Dr. Michael Wolfe, maternal fetal medicine specialist, sees pregnant women at 
the Wichita location, and he and his staff will actively assist with patient recruitment.  Prior to a 
prenatal appointment, Dr. Wolfe will screen potential participants for inclusion criteria, and if he 
believes a participant meets inclusion criteria (see Table 1), then he will contact Dr. Jacobson 
and her research coordinator with the first and last name of the potential participant, and 
date/time of her prenatal appointment.  During this prenatal appointment, Dr. Wolfe will 
familiarize a potential participant with the study’s purpose.  If the potential participant is 
interested in the study, then he will give her a study brochure and a hard copy of the consent 
form.  Prior to using this study brochure, the brochure will be reviewed and approved by the 
Ascension Health Institutional Review Board (IRB).  By providing the potential participant with 
a copy of the consent form, this will serve as the verbal consent script.  After receiving a 
potential participant’s name and appointment time from Dr. Wolfe, the research coordinator will 
follow up on-site to determine if the potential participant again meets study inclusion criteria, 
and if she does, the coordinator will screen if the potential participant meets study exclusion 
criteria at the same time (see Table 1).  Before the research coordinator screens for inclusion and 
exclusion criteria, during this onsite visit, verbal consent will be obtained between the participant 
and the research coordinator, using the consent form as the verbal consent script, and then 
written e-consent will be obtained via REDCap at this same visit.  Once the participant is 
enrolled in the study and over the course of her pregnancy develops one of the conditions 
mentioned under Exclusion (Table 1), then this will be reported to the Data and Safety Officer.  
It will then be decided in consultation with Dr. Wolfe if the participant will be able to continue 
participating in the study or if she will need to be dismissed.      
If the participant meets enrollment criteria, then the 
research coordinator will schedule a virtual 30-minute 
orientation session, to complete study-related survey 
instruments, and to obtain her email address to 
provide her with informed consent materials for 
review.  Participants are informed that they will earn 
incentives to continue and complete the study: (1) a 
$40 Amazon gift card and a pack of diapers at study 
entry, (2) a high-quality digital scale; and (3) a $50 
gift card at study closure.  Investigators will issue 
incentives in accordance with policies set forth by 
IRB (please refer to the heading titled “Self-
Administered Surveys and Incentive to Participate” 
below for additional detail regarding participant 
incentives).  
    
Our recruitment target of pregnant women with pre-pregnancy 
overweight or obesity will involve 15% non-Hispanic Black women, 25% Hispanic women, and 
60% other race including non-Hispanic Whites. We anticipate meeting our recruitment goals 
through multiple approaches: (1) recommendations from physicians and staff; (2) social media; 
Table 1. Enrollment Criteria
Inclusion
1.  Pregnant
2.  In 2nd trimester or early in 3rd trimester
2.  BMI ≥ 25 and < 35
3.  At least 18 years old or older
4.  Be able to read and understand English
5.  Be able to learn and use a video platform
Exclusion
1.  Pregnancy complications that require emergency care  
2.  Thyroid disease 
3.  Multiple gestation
4.  Substance abuse within last 3 years
5.  ART (Assisted Reproductive Technology) pregnancy
6.  Current smoker
7.  Prior bariatric surgery
8.  In weight-loss program within 3 months of conception
9.  BMI ≥ 35
10. Unable to attend intervention/follow-up visits
11. Unwilling to self-monitor data collection
12. Unable to complete intervention
13. Presence of any condition that limits walking
14. Presence of any condition that limits following diet
      recommendations
15. Pregnancies complicated with fetuses diagnosed with
      lethal malformations/conditions

 
 DPP Feasibility Study of Breastfeeding 
 
9 
 
(3) targeted mailings; and (4) clinic posters and study brochures. We will recruit over a period of 
3 months, planning to randomize 3-4 participants each week.  Our goal is to randomize a total of 
50 pregnant women (25 women in each study arm).  Given an attrition rate of 20%, this will 
leave us with 40 women total (20 women in each study arm).  To reach vulnerable populations 
hesitant about engaging in research, we will use successful strategies from previous clinical trials 
with medically underserved populations.84  We will work with trusted community organizations 
(see Letters of Support), engage/train staff who are culturally sensitive, and contact participants 
repeatedly. 
 
E. Study Locations 
Active recruitment will take place at Via Christi Hospitals Wichita, Inc. Doctors at other 
sites and community organizations in the Wichita area may refer their patients to this program 
but will not be assisting in active recruitment.  We will have on-going support from the study 
location.  The principal investigator, Dr. Jacobson, has a long-term collaborative partnership with 
Dr. Wolfe that has resulted in numerous conference presentations and/or publications.  There 
will be additional rural sites interested in participating in this study.  We have a strong letter of 
support from the Sunflower Health Network (SHN) whom we have partnered with on previous 
successful projects (see Appendix 1).  The SHN consists of 26 Critical Access Hospitals (CAH) 
and associated rural clinics, 12 of which provide prenatal/obstetrical services across Kansas' rural 
and frontier counties.  Most importantly, we will have ongoing support for Dr. Jacobson’s work 
from Dr. Michael Wolfe, Maternal Fetal Medicine Specialist, who will see, screen, recruit, and 
provide clinical expertise to his patients (see letter of support, Appendix 2).   
 
Location for affiliated obstetrical clinic above is as follows:  
 
Via Christi Maternal Fetal Medicine Clinic  
1515 South Clifton Avenue, Suite 130 
Wichita, Kansas 67218   
 
F & G. Methodology – Intervention, Study Procedures and Data Collection 
 
The Intervention 
Conceptual Model.  We will use Social Cognitive Theory (SCT)84,85 and Self-Determination 
Theory (SDT)86,87 to guide program development and selection of measures.  SCT stipulates that 
behavior modification results from the interaction between behavior change, cognition (self-
efficacy, perception of barriers to lifestyle changes), and the environment (support), while 
modeling and reinforcement serve to encourage change.  SDT is a broad-based theory of human 
motivation88 that explains how intrinsic motivation can lead to improved eating and exercise 
patterns.89  According to SDT, a person’s increased intrinsic motivation to improve eating and 
exercise patterns should positively relate to self-efficacy and the ability to overcome barriers and 
solicit support.  The DPP plus breastfeeding (Tx1) uses assignments, individualized goal setting, 
and shared problem-solving to increase mastery and goal achievement in incremental steps to 

 
 DPP Feasibility Study of Breastfeeding 
 
10 
 
enhance self-regulatory skills.  Using the Consolidated Framework for Implementation Research 
(CFIR), we will conduct a formative evaluation of the implementation of the DPP-lactation 
mHealth app employing a mixed-methods approach to assess implementation barriers and 
facilitators that influence program outcomes.65  Specific constructs from the CFIR that are most 
relevant to the study setting will guide context, progress, and study results. 66,67  The RE-AIM 
framework 68,69 will also be used to assess Reach, Effectiveness, Adoption, Implementation, and 
Maintenance of the DPP-lactation app (see Approach section for additional detail). 
   
Diabetes Prevention Program (DPP).  The DPP will be administered in two phases by two (2) 
professionally trained and certified health coaches provided by Cappa Health (see Appendix 3).  
Phase I consists of a total of four sessions that will each be one hour long completed during 
pregnancy (see Table 2).  Each of the four (4) sessions/modules of Phase I will be pre-recorded 
and archived on a secure, private mobile health application provided by Cappa Health. Prior to 
starting a DPP session, a participant will be sent a link to the REDCap database to complete a 
survey instrument.  Only Dr. Jacobson, the database manager, the statistician, and the research 
coordinator will have access to this database.    
 
Table 2. Intervention Content and Timeline 
 
 
 
   
We will employ a “rolling” recruitment period of 3 months, meaning that each participant 
may be at different completion stages.  We plan to randomize 3-4 participants each week during 
recruitment.  During their virtual 30-minute orientation session, participants will receive access 
Note: All Phase I content will be completed between gestational 
week (GW) 24 and 36.  The health coach will monitor participants’ 
progress to ensure they complete content by GW36.  All Phase II 
content will be completed by post-partum week (PPW) 12.  
Completion dates should be used as a guide, not as an exact 
completion date.  

 
 DPP Feasibility Study of Breastfeeding 
 
11 
 
to the secure, private mobile health application provided by Cappa Health.  They will be asked to 
complete each Phase I module on their own time, starting in the second/third trimester.  To 
supplement their self-study of the curriculum, on a weekly basis, the health coach will follow up 
with each study participant via phone to check on progress.  If participants do not make adequate 
progress, then the health coach will assess how much extra time the participant needs to 
complete a module, and will work with her one-on-one via Skype, FaceTime or Zoom if needed. 
Participants will complete Phase I by week 36 of pregnancy.  Upon completion of Phase I and 
prior to delivery, participants are invited to attend a virtual focus group to talk about program 
experiences. 
 
Phase II consists of a total of two sessions that will be completed after delivery (see Table 
2).  Each of the two (2) sessions/modules of Phase II will be pre-recorded and archived on the 
same secure, private mobile health application mentioned above. Participants will re-engage into 
Phase II within one week of delivery and with the same health coach as during Phase I. The same 
session completion format and procedure for progress will be followed as during pregnancy. 
Participants will complete Phase II by week 12 postpartum. Upon completion of Phase II, 
participants will be invited to a virtual focus group with other participants to talk about the 
program experiences.  An 80% completion rate of each phase is considered successful 
completion of the intervention.    
 
Breastfeeding.  Additionally, participants in Tx1 will receive an educational session on 
breastfeeding (see Table 2).  Participants in Tx2 will not receive breastfeeding education.  The 2-
hour breastfeeding session is pre-recorded into six (6) 15-20 minute sessions and archived on the 
same secure, private mobile health application as mentioned previously.  Participants will have 
access to the first two lactation sessions by week 24 of pregnancy and they need to complete the 
remaining four sessions by week 36 of pregnancy.  Each of the six lactation sessions is taught by 
the same International Board Certified Lactation Consultant (IBCLC).     
 
At delivery, all participants will receive some type of lactation support in the hospital.  
However, only participants in Tx1 will receive one-on-one lactation support by the same health 
coach who also facilitates the DPP sessions.  The health coaches are professionally trained 
Certified Breastfeeding Specialists (CBS).  In doing so, they will assist the participants with any 
questions related to lactation.  If a participant is having trouble breastfeeding and the health 
coach is having difficulty assessing or helping the participant, the health coach will contact the 
IBCLC-of-record.  This person, Jolynn Dowling, is the same person who recorded the lactation 
curriculum and will provide assistance to and be a resource for the health coach only.  The 
IBCLC will help the health coach answer questions, then the health coach will relay the 
information back to the participant.  If the health coach or IBCLC deems more care necessary, 
the participant will be asked to bring their breastfeeding questions and problems to their primary 
care physician.  The IBCLC will not have direct contact with the study participants, all 
information will be relayed through the health coach.  

 
 DPP Feasibility Study of Breastfeeding 
 
12 
 
Breastfeeding curriculum.  The Kansas Breastfeeding Coalition, Inc. (KBC) in partnership with 
the Kansas Department of Health and Environment (KDHE) Bureau of Family Health (Title V 
Maternal and Child Health Services Program) created a 2-hour breastfeeding class for parents 
and parents-to-be.  The curriculum aligns with nutritional requirements set by the U.S. 
Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants, and 
Children (WIC) and with parenting and maternity care practices of specific Kansas-based 
organizations such as the Kansas Infant Death and SIDS Network, Inc.90 and the United 
Methodist Health Ministry Fund’s High 5 for Mom & Baby.91  Further, the curriculum is based 
on the Office on Women’s Health “Your Guide to Breastfeeding.”92  The content of the 2-hour 
session will focus on the following areas: establishing and maintain a sufficient and safe breast 
milk supply, breast anatomy and physiology, maternal diet and lifestyle choices, prescription and 
non-prescription medications, infant stomach capacity, baby behavior feeding cues, breast milk 
expression, safe handling and storage of breast milk, returning to work, safe preparation of infant 
formula, biologically appropriate bottle feeding, and local community breastfeeding resources.   
 
Potential survey participants will have the option of contacting researchers with any 
questions prior to completing the survey or prior to participating in the educational session, and 
will self-administer the survey if wanting to participate.  Responses will be entered in REDCap 
for data analysis.  All identifying information will be removed from the data prior to analysis.  
Research personnel will not have access to any identifying information contained in the survey.   
 
Self-Administered Surveys and Incentive to Participate.  At recruitment and at study closure, 
participants will complete seven survey instruments; each of which assesses women’s physical 
activity, nutrition, mental health, maternal sleep, breastfeeding knowledge, and breastfeeding 
experience (see Appendices 4 through 12).  Those randomized to Tx2 will complete all survey 
instruments and outcome measures, as are those randomized to the intervention (Tx1).  All 
surveys will be self-administered (see Appendices 4 through 12) and are available in English.  
The pre- and post-survey instruments are identical.  They will be administered electronically at 
baseline (at study entry) and at three months postpartum (see Table 4. Outcomes Measures, 
under Section III).  Via email, the study coordinator will provide each participant with a 
REDCap link that provides electronic access to each survey.  Informed consent will occur when 
the participant opens the survey.  Participants will self-administer the survey and may stop at any 
time.  Potential survey participants will have the option of contacting researchers with any 
questions prior to completing the survey.  The survey instrument will be set up using REDCap 
and responses will be automatically entered and stored in REDCap for data analysis.  All 
identifying information will be removed from the data prior to analysis.  Research personnel will 
not have access to any identifying information contained in the survey.   
 
At recruitment and at study closure 3 months postpartum, all participants will complete 
six pre- and post-survey instruments: (1) Questions on socio-demographic characteristics and 
health status (will only be asked at study entry/baseline) (Appendix 4); (2) Breastfeeding 
Knowledge (Appendix 5); (3) Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) 

 
 DPP Feasibility Study of Breastfeeding 
 
13 
 
(Appendix 6);93-96 (4) Kaiser Physical Activity Survey (KPAS) (Appendix 7);97,98 (5) the Eating 
At America’s Table Study (EATS) Fruit & Vegetable Intake Screener99-101 (Appendix  8); and 
(6) the Pittsburgh Sleep Quality Index (Appendix 9).   Each instrument will take about 10-15 
minutes to complete and participants are provided with adequate time (i.e., about 1 hour) to 
complete all surveys. 
Additionally, recent evidence shows that higher BMI pregnant women may have an 
increased likelihood of depressive and anxiety symptoms.102,103  Therefore, at specific timepoints 
(see Table 4. Outcome Measures, under Section III), all participants will complete the Edinburgh 
Postnatal Depression Scale (EPDS) (Appendix 10)104-106 and the General Anxiety Disorder-7 
(GAD-7) scale (Appendix 11).107  Each scale takes about 5 minutes to complete.  If a participant 
has an elevated score for depressive or anxiety symptoms, then the participant will be referred to 
The Village, a mental health clinic in Wichita, Kansas, or their own mental health care provider 
if the participant has one.  Dr. Jacobson’s research coordinator will ask the study participant if 
she can contact staff at The Village on her behalf and provide them with the participant’s name 
and phone number.  Licensed mental health therapists at The Village will then call the participant 
and attempt to schedule an appointment.  Participants will sign a release form at consent 
allowing Dr. Jacobson and her team to follow up with The Village to record the rate at which 
participants are referred and attend at least one appointment.   
Last, upon delivery and within 72 hours of hospital discharge, the participant will 
complete the Lactation Assessment Care Tool (LACT) (Appendix 12).  The LACT identifies 
families at risk for breastfeeding difficulty and facilitates access to the most effective level of 
care.108 All study survey instruments/scales are listed in Table 3.      
 

 
 DPP Feasibility Study of Breastfeeding 
 
14 
 
 
 
Each participant will receive a $40 gift card and a pack of diapers at consent, prior to 
delivery the participant will receive a digital scale, and upon completion of the study (at 3 
months after birth), each participant will receive a $50 gift card.  In summary, for participants 
randomized to either group: 1) DPP plus breastfeeding, or 2) Usual care, the total possible 
compensation is valued at approximately $140 including the following gift items: digital scale 
and accessories (valued at $35 in total), a $50 study closure gift card, a $40 study entry gift 
card, and a pack of diapers (valued at $11-15 each, depending on the size the mother chooses). 
 
If a participant ends early prior to completing the study, then she will only receive the 
items for the program components that she completed. 
 
Study payments are taxable income.  Prior to distribution of gift items and after 
obtaining consent, a form 1099 will be provided to each participant for completion.  This 
process is in accordance and in compliance with regulations set forth by the University of 
Kansas School of Medicine and the Internal Revenue Service if you receive $600 or more in a 
calendar year for participating in research studies.  
 
Table 3.  Survey Instruments
Study Instrument
Items Measured
No. of Items
Reliability
Populations Validated
Socio-Demographic Characteristics and 
Health Status
To collect data on the 
study sample.
24 items; multiple choice 
and select all that apply
Not yet performed.
Not yet performed.
Breastfeeding Knowledge Assessment
To assess knowledge of 
breastfeeding (44 items), to 
assess socio-demographic 
characteristics (6 items), to 
assess health status (7 
items)
57 items; multiple choice, 
and Likert-type scale
Not yet performed.
Not yet performed.
Breastfeeding Self-Efficacy Scale-Short 
Form (BSES-SF)
To assess levels of self-
efficacy in postpartum 
women.  BSES-SF has also 
been used with prenatal 
women.
14 items; 5-point Likert-type 
scale.
Cronbach's alpha = 0.97
Postpartum women at 1 
week, 4 weeks, and 8 weeks.
Kaiser Physical Activity Survey (KPAS)
To assess multiple 
domains of physical activity 
and total physical activity in 
pregnant women.
38 items; 4 domains: 
household and family care 
activities, occupational 
activities, active living 
habits, participation in 
sports/exercise
Correlation coefficient for total 
activity: r = 0.84; correlation 
coefficient for multiple domains:
r = 0.76 - 0.86
Pregnant women aged 18 to 
47 years old.
Fruit & Vegetable Intake Screener (EATS) To assess intake of fruits 
and vegetables.
10 items; with portion-size 
questions.
Correlation coefficient between test 
instrument and true intake:
r = 0.51-0.67
Correlation coefficient between 
three screeners: r = 0.52 - 0.71
Men and women aged 20 to 
70 years old.
Pittsburgh Sleep Quality Index (PSQI)
To assess levels of 
depression during the 
postpartum period.  
10 items; 4 point scale and 
fill in the blank
Cronbach's alpha = 0.76 - 0.81
Antepartum and postpartum 
women.
Edinburgh Postnatal Depression Scale
(EPDS)
To assess sleep quality.
10 items; 4 point scale
Sensitivity: 34-100%
Specificity: 44-100%
Positive likelihood ratios: 1.61-78
Antepartum and postpartum 
women.
Generalized Anxienty Disorder Scale 
(GAD-7)
To assess levels of 
general anxiety.
7 items; 4-point scale
Cronbach's alpha = 0.92
Sensitivity = 89%
Specificity = 82%
Men and women aged 18 to 
95 years old.
Lactation Assessment Care Tool (LACT)
To identify risk for 
breastfeeding difficulty and 
cessation
16 items; dichotomous scale Not yet performed.
Not yet performed.

 
 DPP Feasibility Study of Breastfeeding 
 
15 
 
Structured Focus Group Discussions.  Upon completion of Phase I and prior to delivery, and at 
study closure, participants are invited to attend a virtual focus group discussion to provide 
feedback on their experience participating in the study. The purpose of this discussion is to 
obtain in-depth information about eMOMSTM program content such as access and delivery of 
materials on breastfeeding, diet, physical activity, and other supportive services during and after 
pregnancy.   
 
Study location and process - The virtual focus group discussions will take place via video call 
(i.e., Zoom technology) and are scheduled between Phase I completion and delivery, and within 
three months of completing Phase II.  Dr. Jacobson or a team member will explain the purpose of 
the focus group and its voluntary nature immediately prior to the focus group discussion.  
Consent is obtained by requesting a participant’s written signature at study entry and during her 
final eMOMSTM visit at 3 months postpartum.  The focus group discussion will take 
approximately 30-60 minutes.  The session will be recorded and notes will be taken.   
 
Risks when participating in the interview - Participation is completely voluntary and a 
participant may stop being in the discussion at any time.  Participants have the opportunity to 
maintain anonymity by changing their name and keeping their camera off during the focus 
group; the only non-anonymous piece of this interview is their voice.  Participation in the 
discussion will not harm a participant physically.  Being in the focus group discussion will not 
affect a participant’s continued or future medical care.  The first potential risk for a participant is 
a possible loss of confidentiality; however, every effort will be made to preserve her privacy.  
Her name is not recorded during the discussion.  Only Dr. Jacobson and the research coordinator 
listen to the recordings and have access to the transcripts of the focus group discussion.  Second, 
if a participant becomes embarrassed or uncomfortable, she may stop participating in the 
discussion at any time.  Participants are asked not to disclose any personal information.  
 
Benefits when participating in the focus group discussion - To the individual, benefits to 
participate in this focus group discussion include a deeper understanding of what is important to 
her during and after pregnancy regarding physical activity, diet, breastfeeding and other 
supportive services.  To the community or society, benefits to participate in the focus group 
discussion include an improved understanding of the importance of physical activity, diet and 
breastfeeding during and after pregnancy.  Aggregate results of these focus group discussions are 
used to inform larger studies that will be designed to develop and implement health promotion 
interventions to improve health outcomes among reproductive age women.   
 
Confidentiality of records - Information collected for these focus group discussions is kept 
confidential and stored in an office with a lock and key.  No one has access to information 
collected other than Dr. Jacobson.  Research records may be reviewed by the Institutional 
Review Board of Ascension or other regulatory authorities.  When the results of these focus 
group discussions are presented or published, participants are not identified by name.  A 
participant may request a copy of the results of these focus group discussions when it is 

 
 DPP Feasibility Study of Breastfeeding 
 
16 
 
completed.  The University of Kansas School of Medicine record retention policy requires 
research records involving human subjects to be kept for at least 15 years so all data associated 
with this study is kept for at least 15 years.  
 
Participation in the focus group discussion – A participant’s participation is completely 
voluntary. She can decline to participate at any point during the focus group discussion.  In 
giving consent, a participant states that her participation in the focus group is voluntary.  She 
receives a copy of the consent form.  If she refuses or wants to stop being in the focus group, 
there will be no penalty or loss of benefits to which she is otherwise entitled.  To stop 
participating in the study, she needs to notify Dr. Jacobson prior to, during, or after the focus 
group discussion. 
         
Contact person for questions - Before a participant signs the consent addendum form, Dr. 
Jacobson will answer all questions.  A participant can speak with Dr. Jacobson if she has any 
more questions, suggestions, concerns or complaints before or after signing the consent 
addendum form.  Dr. Jacobson’s contact information is provided on the consent addendum: Dr. 
Jacobson can be reached at (316) 293-3484 or ljacobson@kumc.edu between the hours of 8 a.m. 
and 5 p.m., Monday through Friday.      
 
Healthcare Provider and Clinic Staff Survey.  At study closure, healthcare providers and 
clinic staff are invited to participate in a survey to provide feedback on their experience being 
involved in the eMOMSTM program.  The purpose of this survey is to assess the willingness of 
the healthcare providers and clinic staff to participate in eMOMSTM, to obtain information on the 
screening and enrollment of pregnant women into the eMOMSTM program from the perspective 
of healthcare providers and clinic staff, to understand the implementation of eMOMS TM from the 
perspective of healthcare providers and clinic staff, to get healthcare provider and clinic staff 
feedback on the program strengths and weakness, and to assess the demographics of healthcare 
providers and clinical staff.  
 
Study location and process - The survey will be distributed online via REDCap once all 
participants have finished the eMOMSTM program.  A title page precedes the survey instrument 
that explains the purpose of the survey.  Consent is obtained prior to starting the survey and is 
located at the bottom of the survey’s title page.  When a respondent consents to participate in the 
survey, he/she checks the box titled “I have had enough time to consider participating, have had 
all my questions answered, and I WOULD like to participate” located at the bottom of the 
survey’s title page.  After clicking on this box, a respondent will then proceed to the next screen 
that includes the first question of the survey.  The survey takes approximately 10-15 minutes.   
 
Risks when participating in the survey - Participation is completely voluntary and anonymous 
and a participant may stop the survey at any time. Participation in the survey will not harm a 
participant physically.  Taking the survey will not affect a participant’s continued or future 
medical care.  The first potential risk for a participant is a possible loss of confidentiality; 

 
 DPP Feasibility Study of Breastfeeding 
 
17 
 
however, every effort will be made to preserve their privacy.  The participant’s name is not 
recorded in the survey.  Only Dr. Jacobson and her KU study team will have access to the survey 
responses.   Participants are asked not to disclose any personal information.  
 
Benefits when participating in the survey - To the individual, benefits to participate in this survey 
include a deeper understanding of what is happening at the healthcare provider and clinical staff 
perspective during the eMOMSTM program.  To the community or society, benefits to participate 
in the survey include an improved understanding of how the healthcare providers and clinical 
staff are able to engage with the eMOMSTM intervention effectively to accomplish its intended 
goals. Aggregate results of these surveys are used to inform larger studies that will be designed 
to develop and implement health promotion interventions to improve health outcomes among 
reproductive age women.   
 
Confidentiality of records – A potential risk of participating in the survey is a breach of 
confidentiality and loss of privacy.  Privacy measures for participant responses to the survey are 
described below.  Yet, to further address privacy, as well as to ensure confidentiality, the 
investigators will ensure the following measures are taken.  All data obtained in the study will be 
kept confidential.  The only parties having access to the data in the proposed study will be the 
Principal Investigator (Dr. Jacobson), Dr. Jacobson’s research team, and the Institutional Review 
Board of record.  Responses to the surveys will be maintained on the KUSM-W REDCap 
database.  Only the necessary members of the research team will have access to the REDCap 
database.  Research records may be reviewed by the Institutional Review Board of Ascension  or 
other regulatory authorities.  When the results of these surveys are presented or published, 
participants are not identified by name.  A participant may request a copy of the results of these 
surveys when it is completed.  The University of Kansas School of Medicine record retention 
policy requires research records involving human subjects to be kept for at least 15 years so all 
data associated with this study is kept for at least 15 years.  
 
Participation in the survey – A respondent’s participation is completely voluntary. He/she can 
decline to participate at any point during the survey.  After consenting to participate in the survey 
by checking the box titled “I have had enough time to consider participating, have had all my 
questions answered, and I WOULD like to participate” located at the bottom of the survey’s title 
page, a respondent will then proceed to the next screen that includes the first question of the 
survey.  If a respondent refuses or wants to stop the survey, there will be no penalty or loss of 
benefits to which they are otherwise entitled.  To stop participating in the survey, the participant 
can exit the survey at any time without submitting it. 
         
Contact person for questions - Before a participant consents to participate, Dr. Jacobson and/or 
Mrs. Meeker will answer all questions.  A participant can speak with Dr. Jacobson and/or Mrs. 
Meeker if he/she has any more questions, suggestions, concerns or complaints before or after 
consenting to participate in the survey.  Dr. Jacobson’s and Mrs. Meeker’s contact information is 
provided on the title page of the survey instrument: Dr. Jacobson can be reached at (316) 293-

 
 DPP Feasibility Study of Breastfeeding 
 
18 
 
3484 or ljacobson@kumc.edu and Mrs. Meeker can be reached at (316) 293-2626 or 
smeeker@kumc.edu between the hours of 8 a.m. and 5 p.m., Monday through Friday. 
 
Section III. Statistical Methods and Data Analysis 
 
Study data will be managed using REDCap electronic data capture tools hosted at the 
University of Kansas School of Medicine – Wichita.109  REDCap (Research Electronic Data 
Capture) is a secure, web-based application designed to support data capture for research studies, 
providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data 
manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external 
sources.   
 
All participant data will be captured and stored in REDCap. The only people who will 
have access to this data are Dr. Jacobson, the database manager, the statistician, and the research 
coordinator. Cleaned data will be downloaded into statistical software for analyses. Clinical data, 
sociodemographic characteristics, and measures for mother and baby will be summarized using 
descriptive statistics. Missing observations will be evaluated for type of missingness. Values 
missing completely at random or at random will be imputed. Analyses will be based on 
intention-to-treat principle. Test results will be considered statistically significant if p<0.05. SAS 
9.4 (SAS/STAT Inst., Carry NC) will be used for all analyses. 
 
Outcome Measures and Rationale for Outcome Measures.  The expected outcomes of this 
study are (1) to quantify user interest; and (2) to measure weight retention and duration of 
lactation (see Table 4). 
 

 
 DPP Feasibility Study of Breastfeeding 
 
19 
 
 
Domain 
Procedure  
Baseline 
DPP-
Lactation 
Phase 1 
 
Delivery 
 
DPP-Lactation 
Phase 2 
Immediately 
prior 
to birth 
 
 
Discharge  
PP Day 7 
PP Wk 3   
PP Mon 1 
PP Wk 6 
PP Mon 2 
PP Mon 3 
Maternal Measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
PhenX Toolkit 
Tier 1 and Core Social Determinants of Health Questionnaires: Educational attainment, 
age, marital status, ethnicity and race, gender, biological sex, birthplace, current 
employment status, food insecurity, health insurance 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
Obstetric history, birth mode, blood glucose during pregnancy, routine vital signs, birth 
weight/length/head circumference 
X 
 
 
 
X 
 
 
 
 
 
 
X 
 
Anthropometrics  
Maternal height and weight in clinic 
X 
 
 
 
 
 
 
 
 
 
 
 
Maternal weight (to derive body mass index)  
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Activity and 
Dietary Intake 
Kaiser Physical Activity Survey (KPAS) 97,98 
X 
 
 
 
 
 
 
 
 
 
 
X 
Fruit and Vegetable Intake Screener (EATS) 99-101 
X 
 
 
 
 
 
 
 
 
 
 
X 
Mental Health Screening 
Edinburgh Postnatal Depression Scale (EPDS) 104,106 
X 
 
 
 
 
 
 
 
 
 
 
X 
Generalized Anxiety Disorder Scale (GAD-7) 107  
X 
 
 
 
 
 
 
 
 
 
 
X 
Maternal Sleep 
Pittsburgh Sleep Quality Index (PSQI) 
X 
 
 
 
 
 
 
 
 
 
 
X 
Infant Measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
Growth 
Infant weight, length, head circumference (per vaccination schedule by WHO) 110 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Feeding Practices* 
Exclusive human milk feedings 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Supplemental infant feedings (i.e., formula, water, juice, etc.) 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Solid food feedings (i.e., cereal, baby food) 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Lactation Assessment 
Breastfeeding Self-Efficacy Scale – Short Form (BSES-SF) 93 
X 
 
 
 
 
 
 
 
 
 
 
X 
Lactation knowledge survey 
X 
 
 
 
 
 
 
 
 
 
 
X 
Lactation Assessment Care Tool (LACT) 
 
 
 
 
 
X 
 
 
 
 
 
 
*Note: Data on feeding practices are collected at these timepoints due to (1) congruent child-wellness visits to the 
primary care provider, and (2) having an established human milk supply and return-to-work by the parent at 3 and 6 
weeks of life. 
 
As this is a pilot trial, we will also collect the following data: number of women screened, 
number of women recruited and enrolled, number of participants who withdraw from the study 
and reasons for withdrawal, number of participants who complete the DPP protocol, and number 
of participants who complete the breastfeeding sessions.  Upon recruitment into the study and at 
study closure, all participants will complete the BSES-SF, KPAS, EATS, PSQI, LACT, EPDS, 
and GAD-7 to assess differences in knowledge and self-efficacy toward breastfeeding, physical 
activity, mental health, maternal sleep, and nutrition.  Table 4 shows a timeline for data 
collection in both study arms.  
 
Aim 1: Quantify interest in use of the DPP-lactation support app among target population. 
To accomplish this, we will: (1) measure research engagement including rates of screening, 
recruitment, and retention among users, especially rural and racially/ethnically diverse women; 
(2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-
depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence 
via tracking/measuring use of the app. 
 
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among 
target population. To accomplish this, we will measure pre-pregnancy weight, weight at study 
entry, weight immediately prior to and after delivery, and weight at specific postpartum time 
Table 4. Outcome Measures and Timeline for Data Collection 

 
 DPP Feasibility Study of Breastfeeding 
 
20 
 
points.  Lactation and infant feeding practices will be measured at similar postpartum time 
points. 
 
Sample Size and Randomization.  The primary outcomes of interest are: (1) to quantify user 
interest; and (2) to measure weight loss and duration of lactation. Given an anticipated attrition 
rate of 20%, a total of 50 participants (25 per study arm) will be recruited.  The results from this 
pilot study will be used in sample size estimation for a future study that is sufficiently powered 
to detect a clinically meaningful effect size.  Due to the nature of this project being a feasibility 
study, the sample size in the proposed study is not based on providing adequate power to detect a 
clinically meaningful effect size across both study arms.  Block randomization with block size of 
5 participants will be employed.  A sequence of 8 random integers will be generated using a 
computer algorithm.  The first 4 integers of the sequence will be assigned to the DPP plus 
breastfeeding arm (Tx1); and the last 4 will be assigned to the usual care arm (Tx2).  Blocks will 
be assigned to arms in the increasing order of sequence of integers generated. Study results will 
be used to determine sample size for a future large-scale RCT that is sufficiently powered to 
detect a clinically meaningful effect size. 
 
Statistical Analysis.  For baseline data characteristics, descriptive statistics will be reported as 
mean and standard deviation for continuous variables and as count and percentage for categorical 
variables.  Depending on the distribution of the continuous variables, the Kruskal-Wallis test or 
ANOVA will be used to test for differences in continuous variables across the three arms.  Chi-
Square test of independence (or Fishers exact test if 25% of cells have counts less than 5) will be 
used to assess the association between categorical variables and the two arms.  The analysis will 
be based on “intention-to-treat” principle.  A two-sided alpha level of 0.05 will be used to 
determine statistical significance.  A 95% confidence interval will also be reported. Consistent 
with procedures described by Guest et al.,111 we will conduct an inductive thematic analysis to 
analyze qualitative data. Using Dedoose software, we will develop a codebook containing 
structural and thematic codes. Consensus will then be reached on emergent primary and sub-
themes. 
 
Aim 1: Quantify interest in use of the DPP-lactation support app among target population.  
 Quantitative variables will be quoted as absolute numbers, rates, and relative frequencies. For 
quantitative variables, likelihood ratio chi-square and Fisher’s exact tests will be conducted to 
test associations between variables. Quantitative data will be analyzed using procedures below. 
 Recruitment/Enrollment, Retention Rates (Primary Outcome for Aim 1). To compute 
recruitment rate, REDCap will track % contacted and % enrolled across week of pregnancy, 
maternal weight/age, rural/urban, and other disadvantaged categories. To compute retention 
rate, we will track % of intervention completers across the same categories, and compare 
characteristics of completers vs. non-completers.  
 Facilitators/Barriers to Research Engagement for Study Participants (Secondary Outcome for 
Aim 1).  Participants will have an opportunity to participate in focus groups/interviews to 

 
 DPP Feasibility Study of Breastfeeding 
 
21 
 
discuss program experiences. Individuals not completing the program will be provided the 
same opportunity. 
 Intervention Uptake, Delivery, Adherence (Tertiary Outcome for Aim 1). REDCap will track 
intervention uptake across each clinic. We will track participants’ app use, time spent on each 
module, time spent with health coach, and other characteristics. Feasibility of 
screening/recruiting among providers will be assessed.  
  
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among 
target population.  
 Continuous data will be assessed for normal or skewed distributions. Descriptive statistics such 
as the mean, standard deviation, median and interquartile range (IQR) will be conducted to 
summarize outcome measures. To assess for potential bias and evaluate retention, those who 
complete the trial will be compared to non-completers. Further, Cochran-Mantel-Haenszel tests 
will be used to reveal associations between categorical/nominal variables after controlling for 
the strata variables. 
 Weight Loss. We will measure maternal weight: at baseline, week 30, week 32, week 34 of 
pregnancy and day 3, day 10, week 3, week 6, month 2, and month 3 postpartum (see Table 4). 
Pre-pregnancy weight/height will be obtained from medical records. 
 Lactation. At delivery, initiation of lactation will be measured (defined as starting lactation at 
birth). We will measure duration of any lactation (defined as predominant human milk with 
formula supplementation) and exclusive lactation (defined as human milk exclusively), at 
specific timepoints (see Table 4). We will also measure formula supplementation when this is 
first introduced, and quantity/frequency of feedings. 
 
Missing data.  Owing to the design of the study and non-transient nature of the study population, 
we anticipate few to none missing observations.  Missing observations will be evaluated for type 
of missingness. Values missing completely at random or at random will be imputed. Depending 
on the proportion of missingness, complete case analysis (less than 5% missing) or the multiple 
imputation method will be used to impute missing data. For longitudinal response (postpartum 
weight measurements), the last observation will be carried forward to impute the missing 
response. Results based on imputed data will be compared to findings from complete case 
analysis, to assess the effect of missingness on study findings. 
 
Comparison of scores on the Breastfeeding Knowledge Assessment, BSES-SF, KPAS, 
EATS, and PSQI.  The Breastfeeding Assessment is based on 44 questions.  Cronbach’s alpha 
will be used to test the internal consistency of the data.  The “difference in Breastfeeding 
Assessment scores between recruitment and at study closure” in both study arms will be assessed 
using the multiple linear regression approach.  The model will be adjusted for the effect of age, 
race/ethnicity, level of education, annual household income, family history of diabetes, pre-
diabetes status, and parity.  The BSES-SF score is based on 14 questions and ranges from 14 to 
70 points.  Cronbach’s alpha will be used to test the internal consistency of the data.  The 
“difference in BSES scores between recruitment and at study closure” across both study arms 

 
 DPP Feasibility Study of Breastfeeding 
 
22 
 
will be assessed using the multiple linear regression approach.  The model will be adjusted for 
the effect of age, race/ethnicity, level of education, annual household income, family history of 
diabetes, pre-diabetes status, and parity.  The KPAS score comprises of 38 questions that are 
distributed sequentially but non-uniformly across four sections and measure household and 
family care activities (household index); occupational activities (occupational index); active 
living habits (active living index); and participation in sports and exercise (sports and exercise 
index).  For each section, Cronbach’s alpha will be used to test the internal consistency of the 
data.  For each index of physical activity, “difference/change between recruitment and at study 
closure” across both study arms will be assessed using the multiple linear regression approach 
after adjusting for the effect of the previously stated covariates.  The EATS survey consists of 10 
questions and the PSQI consists of 10 questions.  For each question, counts and percentages will 
be reported for participants at recruitment and at study closure across both study arms.  
For each survey item, count and percentages will be reported. The difference in scores for each 
survey instrument across both study arms will be assessed using a multiple linear regression 
approach adjusted for the effects of demographic and health status variables. 
 
Section IV. Patient Protections and Methods to Minimize Risk 
 
A. Risks to Human Subjects 
a. Human Subjects Involvement, Characteristics, and Design 
The focus of this research is to implement and determine the feasibility and efficacy of an 
intervention that is based on the Diabetes Prevention Program (DPP) and includes intensive 
breastfeeding support and counseling in a cohort of overweight or obese pregnant women to be 
followed during pregnancy through 6 months postpartum.  Study participants will be pregnant 
women who reside in or near Wichita or northwest rural Kansas.  Participants are eligible if they 
meet study inclusion criteria.  This is a randomized controlled pilot study with two study arms.  
Participants will be randomized to each arm of the study by computer.  Participants in Tx1 will 
receive the DPP plus breastfeeding, and participants in Tx2 will receive usual care.  Usual care 
consists of (1) the same obstetrical care that pregnant women with normal body mass index 
(BMI) receive, and (2) obstetrical care that is provided to pregnant women by the same provider 
(Dr. Michael Wolfe).  Total enrollment for the proposed study will be 50 pregnant female 
participants.     
 
Participants are actively recruited from an obstetrical clinic at Via Christi Hospitals 
Wichita, Inc., a regional medical center located in Wichita, Kansas. Participants must be women 
18 years old or older, pregnant, with a BMI ≥ 25 and <35, and able to read and understand 
English.  Eligible participants will be recruited during the 2nd trimester or early during the 3rd 
trimester.  General study exclusions include women who have pregnancy complications that 
require emergency care, have thyroid disease, have multiple gestation, had substance abuse 
within last 3 years, have an ART (Assisted Reproductive Technology) pregnancy, are a current 
smoker, had prior bariatric surgery, have been in a weight-loss program within 3 months of 
conception, have a BMI ≥ 35, are unable to attend intervention/follow-up visits, are unwilling to 

 
 DPP Feasibility Study of Breastfeeding 
 
23 
 
self-monitor data collection, are unable to complete the intervention, have a presence of any 
condition that limits walking, have a presence of any condition that limits following diet 
recommendations, or have a pregnancy complicated with a fetus diagnosed with lethal 
malformations/conditions. 
 
Vulnerable populations in this study might include economically/educationally 
disadvantaged persons.  Some pregnant women may be economically and/or educationally 
disadvantaged based on their demographic profile.  We especially want to accommodate these 
individuals as our study’s focus is on measuring postpartum weight and breastfeeding behaviors 
among an at-risk ethnically and racially diverse, overweight and obese pregnant population.    
 
We will obtain approval from the Ascension Health Institutional Review Board (IRB).  
With the active assistance of Dr. Wolfe, maternal fetal medicine specialist at VCH, Dr. Jacobson 
and her research coordinator will recruit each participant for the study.  All members of the 
research team involved in consenting and enrolling participants have successfully completed 
institutional Human Subjects training.   
 
b. Sources of materials 
Research material obtained from participants will include: socio-demographic data (i.e. 
age, race/ethnicity, income, education level, etc.), breastfeeding self-efficacy, breastfeeding 
knowledge, physical activity level, dietary assessment, maternal sleep, level of postpartum 
symptoms of depression and anxiety, weight, height, mean arterial blood pressure, blood glucose 
tolerance level during pregnancy, breastfeeding initiation, breastfeeding duration, use of formula, 
and solid food.  All data are based on validated questionnaires (except for the Breastfeeding 
Knowledge Assessment questionnaire), and activity and nutrition monitoring as required by the 
DPP protocol.  The validated measures that will be used are the Breastfeeding Self-Efficacy 
Scale-Short Form (BSES-SF), the Kaiser Physical Activity Survey (KPAS), the Fruit and 
Vegetable Intake Screener (EATS), the Pittsburgh Sleep Quality Index (PSQI), the Edinburgh 
Postnatal Depression Scale (EDPS), the Generalized Anxiety Disorder scale (GAD-7), and the 
Lactation Assessment Care Tool (LACT).  These validated survey instruments will be 
administered at baseline (=study entry) and at study closure (=3 months postpartum) except for 
the LACT which will be administered within 72 hours of hospital discharge after giving birth.  
At delivery and through the 3-month postpartum period, we will also obtain the infant’s height 
and weight via healthcare records.  Further, at delivery, we will measure if the mother starts 
breastfeeding and we will measure how long she will continue breastfeeding through 3 months 
postpartum.                 
 
All behavioral assessments/surveys will be completed in a private room without the 
researcher present.  All DPP orientation sessions and breastfeeding classes will take place at Via 
Christi Health, or if the participant choses to do this virtually, it will take place at their location 
of choice. Collected data will be stored on a secure drive backed up on a nightly basis by the 
Information Technology (IT) department at KUSM-W.  Identification numbers will be assigned 

 
 DPP Feasibility Study of Breastfeeding 
 
24 
 
to each participant at the time of initial survey completion.  All hard-copy and data files will be 
labelled according to participant number.  Only the research team (Dr. Jacobson, the statistician, 
the database manager, and the research coordinator) will have access to information regarding 
demographic and medical information and identification number for each participant.  All other 
data collected throughout the duration of the study will be kept in locked cabinets and on a 
secure server within the University of Kansas School of Medicine-Wichita.  Data used for 
analysis will be de-identified and accessible only by the research team.  A log will be kept of all 
data collection and analysis steps completed for each participant. 
  
c. Potential risks 
Participants will undergo an intervention that is educational.  Participants will share 
education on exercise and diet and will then apply these concepts in their daily functioning.  
During the study, participants’ weight and height will be measured to determine BMI.  During 
pregnancy, the breastfeeding component of the proposed intervention is highly visual and 
interactive.  An International Board Certified Lactation Consultant (IBCLC) will demonstrate 
proper breastfeeding techniques and strategies. After delivery, participants will have access to 
the health coach who is also a Certified Breastfeeding Specialist (CBS) through 3 months 
postpartum.  The IBCLC will be a resource for the CBS; however, the IBCLC will not have 
direct contact with the study participant, only the health coach/CBS has direct contact with the 
participant.  There are no known risks of subjects participating in an educational intervention.  
All data will be kept anonymous and in a locked file cabinet in a locked office.  All data will be 
entered into a computer; electronic data will be on a secure server at KUSM-W that is backed up 
on a nightly basis by the IT department at KUSM-W.        
 
A potential risk of participating in the study is a breach of confidentiality and loss of 
privacy.  Privacy measures for participant responses to the questionnaires are described below.  
Yet, to further address privacy, as well as to ensure confidentiality, the investigators will ensure 
the following measures are taken.  All data obtained in the study will be kept confidential.  The 
only parties having access to the data in the proposed study will be the Principal Investigator (Dr. 
Jacobson), Dr. Jacobson’s research team, and the Institutional Review Board of record.  
Hardcopies of completed participant questionnaires will be locked in a secure file cabinet in the 
PI’s office.  Responses to the surveys and the clinical information obtained will be maintained on 
the KUSM-W REDCap database.  Only the necessary members of the research team will have 
access to the REDCap database.    
 
Participants have the opportunity to post, comment, or like a post in the “Community” 
section of the mobile phone application. If a participant posts, comments, or likes a post in this 
section, their anonymity may be forfeited; however, they have the option to opt for a nickname 
or a pseudonym if they do not want their legal name displayed. 
 
 
 

 
 DPP Feasibility Study of Breastfeeding 
 
25 
 
Adequacy of Protection Against Risks 
a. Recruitment and Informed Consent 
Participants will be recruited from the obstetrical clinic located at Via Christi Hospitals 
Wichita, Inc., a regional medical center located in Wichita, Kansas.  We will use printed flyers, 
posters, and word-of-mouth advertising to recruit potential participants.  Prior to using these 
recruitment materials, Ascension Health Institutional Review Board (IRB) at will review and 
approve these materials.  Dr. Michael Wolfe, a maternal fetal medicine specialist at Via Christi 
Hospitals Wichita, Inc., will make the initial contact with a potential participant during her 
prenatal visit.  Prior to this prenatal appointment, Dr. Wolfe will screen potential participants for 
inclusion criteria, and if he believes a participant meets inclusion criteria (see Table 1), then he 
will contact Dr. Jacobson and her research coordinator with the first and last name of the 
potential participant, and date/time of her prenatal appointment.  During this prenatal 
appointment, if Dr. Wolfe believes a potential participant meets inclusion criteria, then he will 
familiarize her with the nature and purpose of the study.  If the potential participant is interested 
in the study, then he will give her a study brochure and a hard copy of the consent form. After 
receiving a potential participant’s name and phone number from Dr. Wolfe, the research 
coordinator will follow up with a phone call or meet with the interested participant in-person in 
an on-site, private conference room immediately after their prenatal appointment to determine if 
the potential participant again meets study inclusion criteria.  If she does, the coordinator will 
screen if the potential participant meets study exclusion criteria during the same phone call or 
during this same in-person on-site visit (see Table 1).  Before the research coordinator screens 
for inclusion and exclusion criteria, during this same phone call or during this same in-person on-
site visit, verbal consent will be obtained between the participant and the research coordinator, 
using the consent form as the verbal consent script, and then written e-consent will be obtained 
via REDCap at the orientation session.  When a participant is recruited on-site, then the in-
person visit between the participant and the research coordinator is considered to be the 
orientation session. If a participant is recruited through a brochure, website, flyer, word of 
mouth, or by other means, the research coordinator will schedule a call with the potential 
participant. 
 
If the participant meets all study criteria and the participant is contacted via telephone and 
not in-person on-site, then the research coordinator will provide her with a time and place for the 
DPP’s orientation session and to complete study-related survey instruments.  The research 
coordinator will also verify the participant’s email address to provide her with informed consent 
materials for review.  Study procedures will be explained verbally by the PI and in writing at the 
time of survey completion and, again, at the DPP’s orientation session.  All subjects participating 
in the study will consent to participate as evidenced by signing an informed e-consent form via 
REDCap immediately prior to commencement of the orientation session.  Subjects will be 
informed that they are free to withdraw their consent at any time during the study with no 
penalty.  
 

 
 DPP Feasibility Study of Breastfeeding 
 
26 
 
Written informed e-consent will be obtained via REDCap from each participant prior to 
completing the first questionnaire.  A verbal explanation of the study will be provided in addition 
to the written explanation included in the consent form.  Potential participants will be 
encouraged to ask questions concerning the study.  After reading the consent form, participants 
will be asked to provide a verbal summary of the study as they understand it.  This will be used 
to assess the participant's understanding of the study.  If potential participants are able to 
understand, remember, and verbalize the main aspects of the study, it will be assumed that they 
have the capacity to consent.  Participants will be informed that they can withdraw from the 
study at any time by contacting research personnel.  When consent is withdrawn, participation in 
the study will be terminated and no additional data will be collected or used for analysis.  All 
patients will receive a copy of their signed consent form.  The original signed consent forms will 
be kept in a locked file cabinet in a secure data storage room in Dr. Jacobson’s office area, which 
can only be accessed with a key.  
 
b. Protection Against Risk 
All information we obtain throughout the study will be kept confidential.  The risks 
associated with the study are minimal.  No adverse events are anticipated with this study, but 
procedures will be in place to monitor the study using the scientific protocol provided and 
approved by the Institutional Review Board of record.  Participants experiencing any adverse 
effects from participating in this study will be directed to the PI.  Action will be taken to direct 
the study participant to the appropriate resources.   
 
Information collected throughout the course of the study will be de-identified of 
Protected Health Information (PHI) and will only be accessed by research staff directly involved 
with the study.  Researchers believe there is less than minimal risk regarding economic risks and 
legal risks pertaining to this study. However, the risks associated with this project are 
considerably reasonable in comparison to the potential benefits from the study.  
 
c. Adverse Events 
In the case an adverse event was to occur due to study procedures, the principal 
investigator, Dr. Jacobson, will assume responsibility for reporting and documenting any 
complications.  All adverse events will be recorded, and the necessary documents will be 
completed.  The principal investigator and/or the project coordinator will notify the IRB within 
the appropriate time frame. The investigators and project coordinator are responsible for 
complying with any reporting requirement of the reviewing IRB. 
 
A uniquely tailored intervention such as the one proposed may not be enough to support 
pregnant participants with severe obesity and thus, we will only recruit women whose BMI is 
≥25 and <35. Given our previous work, we do not anticipate any problems enrolling pregnant 
participants. Last, we are aware that instruments in this study have been validated, but not 
specifically for medically underserved pregnant populations.   
              

 
 DPP Feasibility Study of Breastfeeding 
 
27 
 
If an adverse event should occur, the participant will have the opportunity to withdraw 
from the study.  Dr. Wolfe will be available for consultation should an adverse event happen.  
Throughout the study, we will be monitoring for issues related to safety of participants as well as 
privacy of data.  Should an adverse event occur, the research team will document the event.  The 
following information will be monitored throughout the study: number of participants screened 
and enrolled, drop-outs, and serious and non-serious adverse events.  This data, with the 
exception of serious adverse events, will be reported every 12-months. Because no serious 
adverse events are anticipated in this study, any such events will be immediately reported to the 
Institutional Review Board of record.  If the severity of an adverse event requires emergency 
medical attention, appropriate providers/staff will be contacted to provide medical attention.  To 
assess participant safety even further, we will have a Data and Safety Officer in place.  Dr. Brian 
Brost has agreed and is confirmed as the Data and Safety Officer for our study.  Brian Brost, 
MD, is professor in the Department of Obstetrics and Gynecology, University of Kansas School 
of Medicine-Kansas City, Mailstop 2028 (Wescoe Pavilion 3000), 3901 Rainbow Boulevard, 
Kansas City, KS  66160.  Dr. Brosts’s email: bbrost@kumc.edu, Main phone: 913.588.6259 or 
913.588.6200. 
 
B. Potential Benefits of the Proposed Research to the Subjects and Others 
The potential benefit of this study is to determine if a combined breastfeeding, DPP-
based intervention reduces postpartum weight, increases lactation duration, among an at-risk 
population with a BMI ≥ 25.  This is an innovative way to address nutrition, physical activity, 
weight, and breastfeeding in one intervention that is modeled after the evidence-based Diabetes 
Prevention Program and could be integrated into the continuum of healthcare services provided 
to culturally, diverse at-risk pregnant women.  Results of the proposed intervention will inform 
the development of interventions aimed at reducing diabetes risk factors and potential 
progression to type 2 diabetes after pregnancy among at-risk women.  The overall impact of this 
project will be to reduce diabetes risk factors among a high-risk population and inform 
interventions aimed at reducing these risk factors thereby decreasing disproportionate morbidity.  
Moreover, study results will add significant knowledge to the field of diabetes prevention and 
related behavioral health interventions and strategies to improve maternal and child health 
outcomes.  Although the randomization process will not be performed by a clinician, instead it 
will be generated by a computer system, participants may still have concerns about bias (who 
receives the treatment versus who receives the control).  We will inform them that, regardless of 
group assignment, they will continue to receive routine care from their maternal fetal medicine 
specialist.      
 
C. Importance of the Knowledge to be Gained 
Knowledge to be gained from this study is whether a combined breastfeeding, DPP-based 
intervention reduces diabetes risk factors among an at-risk population.  Results of this study will 
enhance current intervention efforts that aim to reduce diabetes risk factors and potential 
progression to diabetes during and after pregnancy and improve breastfeeding thereby improving 
maternal and child health outcomes.  An intervention that starts during pregnancy and extends 

 
 DPP Feasibility Study of Breastfeeding 
 
28 
 
beyond pregnancy has a high likelihood of success because during this time period, women are 
more inclined to change their behavior to benefit their children leading to reduced risk of 
retaining excess weight and a possible subsequent healthier pregnancy.  The knowledge, 
methodologies, and strategies obtained from this study will be of importance to the submission 
of a larger research grant such as an R01with the National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK) that will involve a longitudinal study with a larger sample size of 
high-risk, ethnically and racially diverse Kansas women and their children to assess if a 
combined breastfeeding, DPP-based program reduces maternal risk for diabetes and impedes the 
cycle of obesity as a diabetes risk factor among families.  The R01 is a Research Project Grant 
and is the original and historically oldest grant mechanism used by the National Institutes of 
Health (NIH).  The R01 provides support for health-related research and development based on 
the mission of the NIH.  An R01 can be investigator-initiated or can be solicited via a Request for 
Applications by the NIH.  The R01 is an award made to support a discrete, specified, 
circumscribed project to be performed by the named investigators in an area representing the 
investigators’ specific interest and competencies, based on the mission of the NIH.  It is believed 
that the minimal risk involved in the proposed study is reasonable considering that it could lead 
to more effective ways to reduce diabetes risk factors among at-risk populations with a greater 
burden of disease and risk for related health complications.  The proposed pilot study will be the 
first to use an intensive breastfeeding, DPP-based program to reduce diabetes risk factors among 
a vulnerable, at-risk population. 
 
E. Privacy and Confidentiality 
This is an educational intervention utilizing identified pre- and post-surveys.  The privacy 
and confidentiality of potential participants will be maintained as all study data will be protected 
and only study personnel have access.  
 
Only the listed investigators and their designated staff will have access to the surveys and 
study data.  The University of Kansas School of Medicine-Wichita IRB, the US Department of 
Health and Human Services, the Office of Human Research Protections, and other government 
and regulatory bodies as required by law may have access to these research data.  Information 
technology protections and firewalls are in place at all study facilities and will protect the 
electronic data stored at each facility.  Secure email will be used to transfer documents between 
investigators.  The database (participant identifiers removed) will be encrypted and password-
protected when sent through secure email between investigators. 
 
F. Waiver of Documentation of Consent  
A Waiver of Documentation of Consent is not requested for this study.  This study 
presents no more than minimal risk to study participants as the information obtained is not 
sensitive in nature, and if inadvertently released should not be injurious to the participants, either 
financially, legally, or personally.  Surveys will not ask for a participant’s name, medical record 
number, birthdate, social security number, or any other protected health information.  However, 
it is critical that the pre- and post-surveys, along with data on individual weight loss and length 

 
 DPP Feasibility Study of Breastfeeding 
 
29 
 
of breastfeeding are linked to the same individual to assess health outcomes.  Therefore, research 
personnel will seek informed written consent and the process for obtaining written consent is 
outlined previously under Item B. Adequacy of Protection Against Risks, Item A. Recruitment 
and Informed Consent.     
 
G. Adherence to Study Protocol 
Protocol adherence is the primary responsibility of the principal investigator.  The co-
investigators will serve to support protocol adherence efforts and maintain an understanding of 
all protocol details.  Protocol amendments, revisions, deviations will be promptly reported to the 
IRB. 
 
H. Secure and Maintain IRB Approval at All Sites 
IRB approval will include all the study locations listed previously.  All protocol 
deviations, amendments, revisions, and continuing review reports will be promptly compiled and 
reviewed by the principal investigator and co-investigators and provided to the IRB.  All 
research within the scope of this project will be conducted under IRB policies and guidelines. 
 
 I. Obtain IRB Approvals Prior to Implementing Changes to Protocol 
The principal investigator and co-investigators wish to assure the IRB that any 
amendments to the protocol or supporting documents will be submitted for approval prior to 
implementation; problems associated with the research will be reported in accordance with IRB 
policies. 
 
J. Modifications to Study Protocol and Oversight 
Each review will consider whether or not the study should continue without change, be 
modified, or be terminated.  Recommendations regarding modification of the design and conduct 
of the study might include: 
1. Modification of the study protocol based upon review of the safety data;  
2. Optional approaches when the incidence of primary study outcomes is substantially less 
than expected such as recommendations to extend study site;   
3. Corrective actions regarding the study site. 
4. To assess participant safety, we will have a Data and Safety Officer in place. 
 
The principal investigator and co-investigators will provide oversight, supervision and 
monitoring of the data collection and will insure integrity of the data which will ultimately 
ensure subject confidentiality.   
 
K. Monitoring Unanticipated Problems 
The principal investigator, Lisette Jacobson, will assume responsibility for: 
1. Data quality, completeness, and timeliness; 
2. Adherence to the protocol; 

 
 DPP Feasibility Study of Breastfeeding 
 
30 
 
3. Factors that might affect the study outcome or compromise the confidentiality of the trial 
data (such as protocol deviations). 
The principal investigator will consult with the research team/co-investigators regarding protocol 
revisions and amendments before adopting such changes. The IRB will be notified of any 
problems during the conduct of this study. 
 
L. Ensure General Coordination of Study Conduct 
The principal investigator agrees to accept responsibility for the scientific conduct of this 
study and for the rights and welfare of human subjects.  General oversight of the coordination of 
this study will be provided by the principal investigator. 
 
M. Record Retention 
All other study related documents (protocols, databases, IRB documents, surveys) will be 
retained for fifteen (15) years from the data of initial IRB approval and will be kept in the 
principal investigator’s office (University of Kansas School of Medicine - Wichita) under lock 
and key at the conclusion of this study.  At the time of document disposal, documents will be 
shredded according to KUMC Research Institute Record Retention guidelines.  The University 
of Kansas School of Medicine record retention policy requires research records involving human 
subjects to be kept for at least 15 years so all data associated with this study will be kept for at 
least 15 years.   
 
Section V. Results, Source of Funding, and Study Timeline 
 
A. Dissemination of Results 
The findings of this study will be submitted to peer reviewed public health and diabetes 
prevention journals (i.e. American Journal of Public Health, Diabetes, Diabetes Care, Diabetes 
Obesity and Metabolism, Health Education and Behavior, Maternal Child Health Journal, etc.), 
and may be presented at conferences (i.e. Society of Behavioral Medicine, American Public 
Health Association, American Diabetes Association, National Rural Health Association, research 
forums, ACOG, district meetings, obstetrical updates, etc.).  The IRB will be notified at time of 
continuing review of the research project.  Additionally, findings will be used in the future to 
obtain grant funding and for future intervention development. 
 
B. Source of Funding 
This study is funded by the National Institute of General Medical Sciences (NIGMS) in 
collaboration with the National Heart, Lung and Blood Institute (NHLBI), under award number 
5P20GM144269-02S2. 
 
 
 
 
 

 
 DPP Feasibility Study of Breastfeeding 
 
31 
 
 
C. Study Timeline (tentative) 
The following timeline is suggested for study completion. 
Suggested Timeframe 
Completed Objective/Goals 
October 2023 – November 2023 
IRB protocols, preliminary work including 
hiring of research coordinator, and working 
with clinical staff at hospital site 
November 2024 – March 2024 
Finalize planning for participant 
recruitment 
March - May 2024 
Start recruitment (rolling recruitment over a 
3-month period) 
March 2024 – November 2024 
Intervention, data collection, preliminary 
data analysis 
November 2024 
Intervention/trial closes 
November 2024 – December 2024 
Final data analysis, manuscript completion, 
dissemination of findings, preparation for 
R01 submission 
January - February 2025 
R01 submission 
 
 
Section VI. Attachments/Appendices: 
 
1. Appendix 1 – Letter of Support from the Sunflower Health Network 
2. Appendix 2 – Letter of Support from Dr. Michael Wolfe 
3. Appendix 3 – Cappa Health Service Agreement 
4. Appendix 4 – Questions to obtain information on socio-demographic characteristics and 
health status (these data will only be collected at study entry) 
5. Appendix 5 – Survey Instrument: Breastfeeding Knowledge  
6. Appendix 6 – Survey Instrument: Breastfeeding Self-Efficacy Scale-Short From (BSES-
SF) 
7. Appendix 7 – Survey Instrument: Kaiser Physical Activity Survey (KPAS) 
8. Appendix 8 – Survey Instrument: Eating at America’s Table Study (EATS) Fruit and 
Vegetable Intake Screener 
9. Appendix 9 – Survey Instrument: Pittsburgh Sleep Quality Index (PSQI) 
10. Appendix 10 – Survey Instrument: Edinburgh Postnatal Depression Scale (EPDS) 
11. Appendix 11 – Survey Instrument: General Anxiety Disorder (GAD-7) 
12. Appendix 12 – Survey Instrument: Lactation Assessment Care Tool (LACT) 
 
 

 
 DPP Feasibility Study of Breastfeeding 
 
32 
 
References 
 
1. 
Prevention CfDCa. Pregnancy Mortality Surveillance System (PMSS).  
https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-
surveillance-system.htm. Accessed January 24, 2022. 
2. 
Hoyert D. Maternal Mortality Rates in the United States, 2020. NCHS Health E-Stats. 
2022. 
3. 
Neggers YH. Trends in maternal mortality in the United States. Reproductive toxicology 
(Elmsford, NY). 2016;64:72-76. 
4. 
Leonard SA, Main EK, Scott KA, Profit J, Carmichael SL. Racial and ethnic disparities in 
severe maternal morbidity prevalence and trends. Annals of epidemiology. 2019;33:30-
36. 
5. 
Driscoll AK, Gregory ECW. Increases in Prepregnancy Obesity: United States, 2016-2019. 
NCHS data brief. 2020(392):1-8. 
6. 
Zhou T, Du S, Sun D, et al. Prevalence and Trends in Gestational Diabetes Mellitus 
Among Women in the United States, 2006-2017: A Population-Based Study. Frontiers in 
endocrinology. 2022;13:868094. 
7. 
Catalano PM, McIntyre HD, Cruickshank JK, et al. The hyperglycemia and adverse 
pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. 
Diabetes care. 2012;35(4):780-786. 
8. 
Catalano PM, Shankar K. Obesity and pregnancy: mechanisms of short term and long 
term adverse consequences for mother and child. BMJ (Clinical research ed). 
2017;356:j1. 
9. 
Hung TH, Hsieh TT. Pregestational body mass index, gestational weight gain, and risks 
for adverse pregnancy outcomes among Taiwanese women: A retrospective cohort 
study. Taiwanese journal of obstetrics & gynecology. 2016;55(4):575-581. 
10. 
Ovesen PG, Jensen DM, Damm P, Rasmussen S, Kesmodel US. Maternal and neonatal 
outcomes in pregnancies complicated by gestational diabetes. a nation-wide study. J 
Matern Fetal Neonatal Med. 2015;28(14):1720-1724. 
11. 
Yogev, Chen, Hod, et al. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study: 
preeclampsia. American journal of obstetrics and gynecology. 2010;202(3):255.e251-
257. 
12. 
Domanski G, Lange AE, Ittermann T, et al. Evaluation of neonatal and maternal 
morbidity in mothers with gestational diabetes: a population-based study. BMC 
pregnancy and childbirth. 2018;18(1):367. 
13. 
Huang T, Rifas-Shiman SL, Ertel KA, et al. Pregnancy Hyperglycaemia and Risk of Prenatal 
and Postpartum Depressive Symptoms. Paediatric and perinatal epidemiology. 
2015;29(4):281-289. 
14. 
Pinheiro TV, Goldani MZ. Maternal pre-pregnancy overweight/obesity and gestational 
diabetes interaction on delayed breastfeeding initiation. PloS one. 2018;13(6):e0194879. 
15. 
Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational 
diabetes: a systematic review and meta-analysis. Lancet. 2009;373(9677):1773-1779. 

 
 DPP Feasibility Study of Breastfeeding 
 
33 
 
16. 
Lee AJ, Hiscock RJ, Wein P, Walker SP, Permezel M. Gestational diabetes mellitus: 
clinical predictors and long-term risk of developing type 2 diabetes: a retrospective 
cohort study using survival analysis. Diabetes care. 2007;30(4):878-883. 
17. 
Stuebe AM, Rich-Edwards JW, Willett WC, Manson JE, Michels KB. Duration of lactation 
and incidence of type 2 diabetes. JAMA. 2005;294(20):2601-2610. 
18. 
Schwarz EB, Brown JS, Creasman JM, et al. Lactation and maternal risk of type 2 
diabetes: a population-based study. Am J Med. 2010;123(9):863 e861-866. 
19. 
Gunderson EP, Hurston SR, Ning X, et al. Lactation and Progression to Type 2 Diabetes 
Mellitus After Gestational Diabetes Mellitus: A Prospective Cohort Study. Annals of 
internal medicine. 2015;163(12):889-898. 
20. 
Chouinard-Castonguay S, Weisnagel SJ, Tchernof A, Robitaille J. Relationship between 
lactation duration and insulin and glucose response among women with prior 
gestational diabetes. European journal of endocrinology / European Federation of 
Endocrine Societies. 2013;168(4):515-523. 
21. 
Kirkegaard H, Stovring H, Rasmussen KM, Abrams B, Sorensen TI, Nohr EA. How do 
pregnancy-related weight changes and breastfeeding relate to maternal weight and 
BMI-adjusted waist circumference 7 y after delivery? Results from a path analysis. The 
American journal of clinical nutrition. 2014;99(2):312-319. 
22. 
Vinter CA, Jensen DM, Ovesen P, et al. Postpartum weight retention and breastfeeding 
among obese women from the randomized controlled Lifestyle in Pregnancy (LiP) trial. 
Acta obstetricia et gynecologica Scandinavica. 2014;93(8):794-801. 
23. 
Dalrymple KV, Uwhubetine O, Flynn AC, et al. Modifiable Determinants of Postpartum 
Weight Loss in Women with Obesity: A Secondary Analysis of the UPBEAT Trial. 
Nutrients. 2021;13(6). 
24. 
Organization WH. Breastfeeding Recommendations. 2022; https://www.who.int/health-
topics/breastfeeding#tab=tab_2. Accessed September 21, 2022. 
25. 
Pediatrics AAo. Policy Statement Breastfeeding and the Use of Human Milk. Pediatrics. 
2012;129(3). 
26. 
Meek JY, Noble L. Policy Statement: Breastfeeding and the Use of Human Milk. 
Pediatrics. 2022;150(1). 
27. 
Prevention CfDCa. Breastfeeding Among U.S. Children Born 2011–2018, CDC National 
Immunization Survey.  https://www.cdc.gov/breastfeeding/data/nis_data/results.html. 
Accessed June 15, 2022. 
28. 
Badon SE, Enquobahrie DA, Wartko PD, et al. Healthy Lifestyle During Early Pregnancy 
and Risk of Gestational Diabetes Mellitus. American journal of epidemiology. 
2017;186(3):326-333. 
29. 
Bruno R, Petrella E, Bertarini V, Pedrielli G, Neri I, Facchinetti F. Adherence to a lifestyle 
programme in overweight/obese pregnant women and effect on gestational diabetes 
mellitus: a randomized controlled trial. Maternal & child nutrition. 2017;13(3). 
30. 
Deng Y, Hou Y, Wu L, Liu Y, Ma L, Yao A. Effects of Diet and Exercise Interventions to 
Prevent Gestational Diabetes Mellitus in Pregnant Women With High-Risk Factors in 
China: A Randomized Controlled Study. Clinical nursing research. 2022;31(5):836-847. 

 
 DPP Feasibility Study of Breastfeeding 
 
34 
 
31. 
Renault KM, Carlsen EM, Hædersdal S, et al. Impact of lifestyle intervention for obese 
women during pregnancy on maternal metabolic and inflammatory markers. 
International journal of obesity (2005). 2017;41(4):598-605. 
32. 
Ferrara A, Hedderson MM, Albright CL, et al. A pregnancy and postpartum lifestyle 
intervention in women with gestational diabetes mellitus reduces diabetes risk factors: 
a feasibility randomized control trial. Diabetes care. 2011;34(7):1519-1525. 
33. 
Nicklas JM, Zera CA, England LJ, et al. A web-based lifestyle intervention for women with 
recent gestational diabetes mellitus: a randomized controlled trial. Obstetrics and 
gynecology. 2014;124(3):563-570. 
34. 
Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 
diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403. 
35. 
Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and 
weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 
2009;374(9702):1677-1686. 
36. 
Aroda VR, Christophi CA, Edelstein SL, et al. The effect of lifestyle intervention and 
metformin on preventing or delaying diabetes among women with and without 
gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-
up. The Journal of clinical endocrinology and metabolism. 2015;100(4):1646-1653. 
37. 
Katula JA, Dressler EV, Kittel CA, et al. Effects of a Digital Diabetes Prevention Program: 
An RCT. American journal of preventive medicine. 2022;62(4):567-577. 
38. 
Staite E, Bayley A, Al-Ozairi E, et al. A Wearable Technology Delivering a Web-Based 
Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized 
Controlled Trial. JMIR mHealth and uHealth. 2020;8(7):e15448. 
39. 
Jacobson LT, Duong, J., Grainger, D. A., Collins, T. C., Farley, D., Wolfe, M., Dong, F., 
Anderson, B. Health assessment of a rural obstetrical population in a Midwestern state. 
Journal of Pregnancy and Child Health. 2016;3(2). 
40. 
Jacobson LT, Twumasi-Ankrah P, Redmond ML, et al. Characteristics associated with 
breastfeeding behaviors among urban versus rural women enrolled in the Kansas WIC 
program. Maternal and child health journal. 2015;19(4):828-839. 
41. 
Jacobson LT, Dong F, Scheuermann TS, Redmond ML, Collins TC. Smoking Behaviors 
Among Urban and Rural Pregnant Women Enrolled in the Kansas WIC Program. Journal 
of community health. 2015. 
42. 
Scheuermann TS, Richter KP, Jacobson LT, Shireman TI. Medicaid Coverage of Smoking 
Cessation Counseling and Medication is Underutilized for Pregnant Women. Nicotine & 
tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 
2017 (forthcoming). 
43. 
Jacobson LT, Collins TC, Lucas M, et al. Electronic Monitoring of Mom's Schedule 
(eMOMSTM): Protocol for a feasibility randomized controlled trial to improve 
postpartum weight, blood sugars, and breastfeeding among high BMI women. 
Contemporary Clinical Trials Communications. 2020;18:1-10. 
44. 
Jacobson LT, Wolfe M, Zackula R, et al. Electronic Monitoring Of Mom's Schedule 
(eMOMSTM): Recruitment of pregnant populations with elevated BMI in a feasibility 
randomized controlled trial. Preventive medicine reports. 2023;34:102254. 

 
 DPP Feasibility Study of Breastfeeding 
 
35 
 
45. 
Jacobson LT, Bakhache N, Dowling J, et al. Electronic Monitoring of Mom's Schedule 
(eMOMSTM): A Qualitative Study of Experiences in a Lifestyle Change Program with 
Lactation Support. American journal of health promotion : AJHP. 2023;37(7):953-963. 
46. 
Chen P, Wang S, Ji J, et al. Risk factors and management of gestational diabetes. Cell 
Biochem Biophys. 2015;71(2):689-694. 
47. 
Cypryk K, Szymczak W, Czupryniak L, Sobczak M, Lewinski A. Gestational diabetes 
mellitus - an analysis of risk factors. Endokrynol Pol. 2008;59(5):393-397. 
48. 
Bottalico JN. Recurrent gestational diabetes: risk factors, diagnosis, management, and 
implications. Semin Perinatol. 2007;31(3):176-184. 
49. 
Mao L, Ge X, Xu Y, et al. [Pregestational body mass index, weight gain during first half of 
pregnancy and gestational diabetes mellitus: a prospective cohort study]. Zhonghua Liu 
Xing Bing Xue Za Zhi. 2015;36(5):416-420. 
50. 
Spong CY, Guillermo L, Kuboshige J, Cabalum T. Recurrence of gestational diabetes 
mellitus: identification of risk factors. Am J Perinatol. 1998;15(1):29-33. 
51. 
Athukorala C, Rumbold AR, Willson KJ, Crowther CA. The risk of adverse pregnancy 
outcomes in women who are overweight or obese. BMC pregnancy and childbirth. 
2010;10:56. 
52. 
Burstein E, Levy A, Mazor M, Wiznitzer A, Sheiner E. Pregnancy outcome among obese 
women: a prospective study. Am J Perinatol. 2008;25(9):561-566. 
53. 
Denison FC, Norwood P, Bhattacharya S, et al. Association between maternal body mass 
index during pregnancy, short-term morbidity, and increased health service costs: a 
population-based study. BJOG. 2014;121(1):72-81; discussion 82. 
54. 
Gaillard R, Durmus B, Hofman A, Mackenbach JP, Steegers EA, Jaddoe VW. Risk factors 
and outcomes of maternal obesity and excessive weight gain during pregnancy. Obesity 
(Silver Spring). 2013;21(5):1046-1055. 
55. 
Al-Kubaisy W, Al-Rubaey M, Al-Naggar RA, Karim B, Mohd Noor NA. Maternal obesity 
and its relation with the cesarean section: a hospital based cross sectional study in Iraq. 
BMC pregnancy and childbirth. 2014;14:235. 
56. 
Bhattacharya S, Campbell DM, Liston WA, Bhattacharya S. Effect of Body Mass Index on 
pregnancy outcomes in nulliparous women delivering singleton babies. BMC Public 
Health. 2007;7:168. 
57. 
Gaillard R, Steegers EA, Duijts L, et al. Childhood cardiometabolic outcomes of maternal 
obesity during pregnancy: the Generation R Study. Hypertension. 2014;63(4):683-691. 
58. 
Harpsoe MC, Basit S, Bager P, et al. Maternal obesity, gestational weight gain, and risk of 
asthma and atopic disease in offspring: a study within the Danish National Birth Cohort. 
The Journal of allergy and clinical immunology. 2013;131(4):1033-1040. 
59. 
Hinkle SN, Sharma AJ, Swan DW, Schieve LA, Ramakrishnan U, Stein AD. Excess 
gestational weight gain is associated with child adiposity among mothers with normal 
and overweight prepregnancy weight status. The Journal of nutrition. 
2012;142(10):1851-1858. 
60. 
Masho SW, Cha S, Morris MR. Prepregnancy obesity and breastfeeding noninitiation in 
the United States: an examination of racial and ethnic differences. Breastfeed Med. 
2015;10(5):253-262. 

 
 DPP Feasibility Study of Breastfeeding 
 
36 
 
61. 
Reynolds RM, Allan KM, Raja EA, et al. Maternal obesity during pregnancy and 
premature mortality from cardiovascular event in adult offspring: follow-up of 1 323 275 
person years. BMJ (Clinical research ed). 2013;347:f4539. 
62. 
Stothard KJ, Tennant PW, Bell R, Rankin J. Maternal overweight and obesity and the risk 
of congenital anomalies: a systematic review and meta-analysis. Jama. 2009;301(6):636-
650. 
63. 
Gunderson EP, Abrams B. Epidemiology of gestational weight gain and body weight 
changes after pregnancy. Epidemiol Rev. 2000;22(2):261-274. 
64. 
Rooney BL, Schauberger CW. Excess pregnancy weight gain and long-term obesity: one 
decade later. Obstetrics and gynecology. 2002;100(2):245-252. 
65. 
Gilmore LA, Klempel-Donchenko M, Redman LM. Pregnancy as a window to future 
health: Excessive gestational weight gain and obesity. Seminars in perinatology. 
2015;39(4):296-303. 
66. 
Norman JE, Reynolds RM. The consequences of obesity and excess weight gain in 
pregnancy. Proc Nutr Soc. 2011;70(4):450-456. 
67. 
Gunderson EP, Hedderson MM, Chiang V, et al. Lactation intensity and postpartum 
maternal glucose tolerance and insulin resistance in women with recent GDM: the 
SWIFT cohort. Diabetes care. 2012;35(1):50-56. 
68. 
O'Reilly M, Avalos G, Dennedy MC, O'Sullivan EP, Dunne FP. Breast-feeding is associated 
with reduced postpartum maternal glucose intolerance after gestational diabetes. Irish 
medical journal. 2012;105(5 Suppl):31-36. 
69. 
Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia 
Pac J Public Health. 2016;28(1):7-14. 
70. 
Martin J, MacDonald-Wicks L, Hure A, Smith R, Collins CE. Reducing postpartum weight 
retention and improving breastfeeding outcomes in overweight women: a pilot 
randomised controlled trial. Nutrients. 2015;7(3):1464-1479. 
71. 
Stuebe AM, Rich-Edwards JW. The reset hypothesis: lactation and maternal metabolism. 
American journal of perinatology. 2009;26(1):81-88. 
72. 
U.S. Department of Health and Human Services. National Institutes of Health. Diabetes 
Prevention Program. In:2008. 
73. 
Winkvist A, Brantsaeter AL, Brandhagen M, Haugen M, Meltzer HM, Lissner L. Maternal 
Prepregnant Body Mass Index and Gestational Weight Gain Are Associated with 
Initiation and Duration of Breastfeeding among Norwegian Mothers. J Nutr. 
2015;145(6):1263-1270. 
74. 
Verret-Chalifour J, Giguere Y, Forest JC, Croteau J, Zhang P, Marc I. Breastfeeding 
initiation: impact of obesity in a large Canadian perinatal cohort study. PloS one. 
2015;10(2):e0117512. 
75. 
Thompson LA, Zhang S, Black E, et al. The association of maternal pre-pregnancy body 
mass index with breastfeeding initiation. Maternal and child health journal. 
2013;17(10):1842-1851. 
76. 
Matthews KA, Croft JB, Liu Y, et al. Health-Related Behaviors by Urban-Rural County 
Classification - United States, 2013. Morbidity and mortality weekly report Surveillance 
summaries (Washington, DC : 2002). 2017;66(5):1-8. 

 
 DPP Feasibility Study of Breastfeeding 
 
37 
 
77. 
Hardin-Fanning F, Rayens MK. Food cost disparities in rural communities. Health 
promotion practice. 2015;16(3):383-391. 
78. 
Taber DR, Chriqui JF, Quinn CM, Rimkus LM, Chaloupka FJ. Cross-sector analysis of 
socioeconomic, racial/ethnic, and urban/rural disparities in food policy enactment in the 
United States. Health & place. 2016;42:47-53. 
79. 
Lutfiyya MN, Chang LF, Lipsky MS. A cross-sectional study of US rural adults' 
consumption of fruits and vegetables: do they consume at least five servings daily? BMC 
public health. 2012;12:280. 
80. 
Larson NI, Story MT, Nelson MC. Neighborhood environments: disparities in access to 
healthy foods in the U.S. American journal of preventive medicine. 2009;36(1):74-81. 
81. 
Bunik M, Clark L, Zimmer LM, et al. Early infant feeding decisions in low-income Latinas. 
Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 
2006;1(4):225-235. 
82. 
Chapman DJ, Perez-Escamilla R. Breastfeeding among minority women: moving from 
risk factors to interventions. Advances in nutrition (Bethesda, Md). 2012;3(1):95-104. 
83. 
Sloand E, Budhathoki C, Junn J, Vo D, Lowe V, Pennington A. Breastfeeding among Latino 
Families in an Urban Pediatric Office Setting. Nursing research and practice. 
2016;2016:9278401. 
84. 
Bandura A. Human agency in social cognitive theory. The American psychologist. 
1989;44(9):1175-1184. 
85. 
Bandura A. Self-efficacy mechanism in human agency. The American psychologist. 
1982;37(2):122-147. 
86. 
Deci EL, Ryan RM. The empirical exploration of intrinsic motivational processes. New 
York, NY: Academic Press; 1980. 
87. 
Deci EL, Ryan RM. A motivational approach to self: Integration in personality. In: 
Dienstbier R, ed. Nebraska Symposium on Motivation: Volume 38 Perspectives on 
Motivation. Lincoln, NE: University of Nebraska Press; 1991. 
88. 
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, 
social development, and well-being. The American psychologist. 2000;55(1):68-78. 
89. 
Deci EL, Ryan RM. Intrinsic motivation and self-determination in human behavior. New 
York, NY: Plenum; 1985. 
90. 
Tørris C, Thune I, Emaus A, et al. Duration of lactation, maternal metabolic profile, and 
body composition in the Norwegian EBBA I-study. Breastfeed Med. 2013;8(1):8-15. 
91. 
Wiklund P, Xu L, Lyytikäinen A, et al. Prolonged breast-feeding protects mothers from 
later-life obesity and related cardio-metabolic disorders. Public health nutrition. 
2012;15(1):67-74. 
92. 
U.S. Department of Health and Human Services' Office on Women's Health. Your Guide 
to Breastfeeding. In. Washington DC: Office on Women's Health; 2011:48. 
93. 
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short 
form. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN / NAACOG. 
2003;32(6):734-744. 
94. 
Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A 
Critical Review of Available Instruments. J Hum Lact. 2016;32(1):35-45. 

 
 DPP Feasibility Study of Breastfeeding 
 
38 
 
95. 
Creedy DK, Dennis CL, Blyth R, Moyle W, Pratt J, De Vries SM. Psychometric 
characteristics of the breastfeeding self-efficacy scale: data from an Australian sample. 
Res Nurs Health. 2003;26(2):143-152. 
96. 
Otsuka K, Taguri M, Dennis CL, et al. Effectiveness of a breastfeeding self-efficacy 
intervention: do hospital practices make a difference? Maternal and child health journal. 
2014;18(1):296-306. 
97. 
Ainsworth BE, Sternfeld B, Richardson MT, Jackson K. Evaluation of the kaiser physical 
activity survey in women. Medicine and science in sports and exercise. 2000;32(7):1327-
1338. 
98. 
Schmidt MD, Freedson PS, Pekow P, Roberts D, Sternfeld B, Chasan-Taber L. Validation 
of the Kaiser Physical Activity Survey in pregnant women. Medicine and science in sports 
and exercise. 2006;38(1):42-50. 
99. 
Thompson FE, Subar AF, Smith AF, et al. Fruit and vegetable assessment: performance of 
2 new short instruments and a food frequency questionnaire. J Am Diet Assoc. 
2002;102(12):1764-1772. 
100. 
Yaroch AL, Tooze J, Thompson FE, et al. Evaluation of three short dietary instruments to 
assess fruit and vegetable intake: the National Cancer Institute's food attitudes and 
behaviors survey. J Acad Nutr Diet. 2012;112(10):1570-1577. 
101. 
George SM, Thompson FE, Midthune D, et al. Strength of the relationships between 
three self-reported dietary intake instruments and serum carotenoids: the Observing 
Energy and Protein Nutrition (OPEN) Study. Public Health Nutr. 2012;15(6):1000-1007. 
102. 
Ruyak SL, Corwin EJ, Lowe NK, Neu M, Boursaw B. Prepregnancy Obesity and a 
Biobehavioral Predictive Model for Postpartum Depression. Journal of obstetric, 
gynecologic, and neonatal nursing : JOGNN / NAACOG. 2016. 
103. 
Records K, Keller C, Coonrod D, et al. Correlates of depressive symptoms after birth for 
Latinas who are overweight or obese. Health Care Women Int. 2015;36(3):356-374. 
104. 
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 
10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782-786. 
105. 
Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 
2002;347(3):194-199. 
106. 
Gibson J, McKenzie-McHarg K, Shakespeare J, Price J, Gray R. A systematic review of 
studies validating the Edinburgh Postnatal Depression Scale in antepartum and 
postpartum women. Acta Psychiatr Scand. 2009;119(5):350-364. 
107. 
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized 
anxiety disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-1097. 
108. 
Wessells A, Chertok IRA, Haile ZT, Johnston J. Development and Interrater Reliability of 
the Lactation Assessment Care Tool. Journal of human lactation : official journal of 
International Lactation Consultant Association. 2023;39(1):30-39. 
109. 
Saydah SH, Chandra A, Eberhardt MS. Pregnancy experience among women with and 
without gestational diabetes in the U.S., 1995 National Survey Of Family Growth. 
Diabetes care. 2005;28(5):1035-1040. 
110. 
Centers for Disease Control and Prevention NCfHS. WHO Growth Standards Are 
Recommended for Use in the U.S. for Infant and Children 0 to 2 Years of Age.  
https://www.cdc.gov/growthcharts/who_charts.htm. Accessed July 13, 2022. 

 
 DPP Feasibility Study of Breastfeeding 
 
39 
 
111. 
Guest G, Namey EE, Mitchell ML. Collecting Qualitative Data: A Field Manual for Applied 
Research. 1st ed. Thousand Oaks, California: SAGE Publications, Inc.; 2013.