Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Phase: NA
Conditions: Breastfeeding, Exclusive, Pain, Acute, Maternal Distress, Parent-Child Relations, Self Efficacy
Sponsor: University of Connecticut

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Promoting Self-Management of Breast and Nipple Pain with Biomarkers and Technology 
(PROMPT) for Breastfeeding Women study (1 R01 NR020041-01) RCT
Purpose/Introduction:  
Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for 
optimal maternal well-being and to promote their infant’s health, physical growth, and development.1–3 
The highest rate of BF cessation occurs within 3 weeks after delivery, with 30% of women ceasing BF 
due to acute breast and nipple pain (BNP).4–6 BNP is a complex and understudied biobehavioral 
phenomenon involving nociceptive signaling that stimulates multiple pathways - somatic (mechanical 
compression and cracked nipples), visceral (uterine cramping), and the autonomic nervous system 
(engorgement).7–10 Enhanced pain sensitivity, a physiologic pro-nociceptive state measured by 
somatosensory function and genomics, may increase women’s sensitivity to BNP.10,11 Women who 
experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, 
and increased symptoms of maternal distress (anxiety, depression, stress, and fatigue), which contribute to 
a greater risk of early BF cessation (< 3 weeks BF), decreased maternal well-being, and low maternal 
self-efficacy to care for their infant.12–15 Thus, a critical gap exists in identifying effective biobehavioral 
self-management interventions for women during BF initiation to manage BNP, increase BF self-efficacy, 
BF duration and decrease symptoms of maternal distress.16–19 
In a pilot RCT (P20NR016605 - UConn IRB #H16-321)), we developed a patient-informed Breastfeeding 
and BNP Self-Management (BSM) intervention based on the Individual and Family Self-Management 
Theory and tested its feasibility among women initiating BF.20–22 The BSM intervention was designed to 
address modifiable variables for women initiating BF.23–26 Based on the needs and preferences elicited 
from a diverse sample of BF women, we used a cloud-based platform, to deliver BF knowledge and 
skills, and provided support through nurse led text-based communication to decrease BNP, increase BF 
self-efficacy, and increase adaptive coping behaviors.27–30 The RCT pilot was successful, with 92% 
retention and 87% of women continued BF until study end.22 Women in the BSM intervention group with 
and without prior BF experience reported significantly reduced BNP intensity and pain interference at 1 
and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. BNP intensity 
was associated with pain sensitivity single nucleotide polymorphisms (SNPs) (Oxytocin receptor (OXTR) 
rs53576, rs2254298), suggesting a genetic risk profile of heightened BNP and linked to perinatal 
depression (OXTR DNA methylation) which together could be used to identify women at high risk of 
early BF cessation and pain sensitivity.22,31–36 Our innovative pilot study was the first to address BNP 
using the BSM intervention. In this application, we propose a large-scale RCT to further test the efficacy 
of the intervention on BNP, BF self-efficacy, maternal well-being, and BF exclusivity to 6 months.22
Based on our promising preliminary data, we propose to examine the effectiveness of the BSM 
intervention in an R01 RCT, Promoting Self-Management of Breast and Nipple Pain with Biomarkers 
and Technology (PROMPT) for Breastfeeding Women, on BNP and BF outcomes (exclusivity and 
duration). Women (N=280) will be randomized to the BSM intervention or an attention control (general 
postpartum and infant care) group. At baseline, women will be assessed for BNP intensity and 
interference, and contextual factors of BSM (pain sensitization using quantitative sensory testing, buccal 
cell and/or blood samples ((2) 5 ml EDTA tubes and (2) 2.5 ml DNA/RNA tubes (15 ml or 3 teaspoons) 
at each visit for total of 9 teaspoons) for select pain sensitivity and milk supply SNPs and DNA 
methylation). After initiation of the intervention, women will be assessed at 1, 2, 3, 6, 9, 12, 18, and 24 
weeks for BNP, BF exclusivity, BF self-efficacy, maternal well-being, and at 6 and 24 weeks for DNA 
methylation of pain and milk supply and ongoing pain sensitization. The specific aims (SA) and 
hypotheses (H) of the PROMPT study are to:
SA1: Examine the effect of the BSM intervention on the primary outcome of BNP intensity and 
interference between the intervention and attention control group controlling for prior BF experience 
across all data points. 
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H1: The BSM group will report significantly lower BNP intensity and interference at 1, 2, and 3 weeks 
and significantly lower cumulative BNP score over time compared to the AC group. 
SA2: Examine the effect of the BSM intervention on secondary outcomes of BF exclusivity, BF self-
efficacy, and maternal well-being. 
H2A: The BSM group will have a higher proportion of women with exclusive BF at 6, 9, 12, 18, and 24 
weeks and higher BF self-efficacy at all-time points compared to the attention control group. H2B: The 
BSM group will have higher maternal well-being compared to the attention control group at each time 
point. 
SA3: Explore (1) the influence of pain sensitivity (quantitative sensory testing, select buccal cell and/or 
blood samples for pain sensitivity SNPs and in a subsample, DNA methylation of select sensitivity SNPs 
(40 participants (5 zero and 15 highest pain phenotype per group) on BNP intensity and interference; and 
(2) BF outcomes in SA2, maternal and pain self-efficacy over time between groups.  
SA4: Explore (1) the influence of pain sensitivity and lactation (blood samples for pain sensitivity and 
lactation SNPs [OXTR and PRL]) on perception of milk supply (BSES and HH lactation scale). 
Aligned with the Maternal and Infant Care goals of Healthy People 2020, NINR strategic themes of 
symptom science and self-management, NICHD optimal infant and maternal heath during the fourth 
trimester, and the CDC HEAR HER campaign, the proposed study will address a major barrier to BF 
initiation and exclusivity by testing the effectiveness of the BSM intervention to decrease BNP intensity 
and interference and increase BF self-efficacy and support maternal well-being. The BSM intervention is 
easily accessible and clinically sustainable allowing for large-scale translation in health care and public 
health settings. 
Significance 
A key preventative health behavior for lifelong health is 
breastfeeding.1 Women who reported a cumulative breastfeeding (BF) 
history of 12 months or more decrease their risk for breast cancer and cardiovascular disease.1,3,37 BF 
supports maternal well-being during the fourth trimester of pregnancy after birth by decreasing the risk of 
depression, anxiety, and stress symptoms, and increases maternal self-efficacy.38–43 BF also provides 
lifelong infant health benefits; the longer infants exclusively BF, the greater benefit in reducing infantile 
and respiratory diseases (COVID-19), and chronic diseases related to obesity.2,44,45 In 2019, 83.2% of 
women-initiated BF, unfortunately, 3 weeks after birth the rate of exclusive BF dropped to 62% 
triggered by breast and nipple pain (BNP),4,6,19,46–49 thus, BF health benefits for women and infants 
are lost.1,2 The public health goal to receive optimal health benefits from BF is 6 months of BF, which 
requires women to maintain their milk supply for at least 9 weeks.50 The early cessation of BF (before 3 
weeks) costs society an estimated $3.0 billion annually (2010 dollars) due to purchase of formula, increased 
infantile diseases and health visits, and lost wages ($2.3 billion being maternal cost).2,51 
BNP leads to BF cessation. Clinically, BNP during BF initiation is managed as a “normal” phenomenon 
that women experience.8,52 For women who experience unresolved BNP during BF, BNP triggers a 
complex feedback loop which creates a challenging situation that includes stimulation from the glandular, 
somatic, and visceral tissues, which is transmitted via nociceptors pathways.10,53,54 During the critical 2-3 
weeks of BF, women will continue BF with BNP, to provide optimal nutrition and build their maternal self-
efficacy, detrimentally, for each day of ongoing BNP, the risk of BF cessation increases by 10-26%.19,48,55–
57 Common triggers of BNP are related to anatomic factors, such as abnormal nipple shape, pumping, and 
ankyloglossia, or an infectious process. These triggers may be resolved with guided BF interventions and 
treatment.58–63 However, without resolution, 30% of women (1 million) cease BF early due ongoing BNP 
which disrupts the neurohormonal cascade of lactation triggering inadequate milk volume and a lack of 
Exclusive BF is defined as 
infants receiving only breast 
milk from the breast or from 
expressed breast milk 
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infant satiation.6,9,19,34,35,46,47,64–67 At 1 and 3 months, 20 – 30% and 16% of women, respectively, 
experience ongoing pain even with professional lactation intervention. 68–70 The persistence of pain without 
medical conditions or anatomic anomalies suggests a genetic risk of pain sensitivity and insufficient milk 
supply.10,31,36,71,72 A genetic risk of enhanced pain sensitivity may be used to identify women at high-
risk for pain-related BF cessation and target precision interventions for BNP and also be a pathway to 
identifying women at risk for chronic pain due to a pain sensitivity phenotype.11,31 
Based on the voluminous evidence regarding the effectiveness of pain-specific, non-pharmacological self-
management strategies, the scientific premise of this application is to provide knowledge and skills at BF 
initiation to prevent BNP, increase coping mechanism and change behaviors if BNP occurs.8,10,73–77 
Cognitive-behavioral and self-management interventions directed at clinical and chronic pain conditions 
(guided imagery, therapeutic breathing, mindfulness, relaxation, use and safety of analgesics have not 
been applied BNP to facilitate BF exclusivity and duration.8,10,73–80 A key consideration for women with 
ongoing BNP (>2 weeks) is that similar to women with chronic pain conditions,77,81–84 women are at 
greater risk for alterations in self-efficacy, mood disturbances, activities of daily living, and in sleep 
cycles affecting their general well-being.54,85–90 Decreased maternal well-being adversely affects maternal 
self-efficacy with enduring and negative impact on the maternal/infant dyad and typical infant growth and 
development.12,15,19,66,91,92 To address both the lack of theoretically driven content for integration of 
Breastfeeding and BNP self-management, lack of maternal strategies regarding BNP, and issues of 
intervention sustainability in the clinical setting, our team employed user-centered design methodology to 
develop the Breastfeeding and BNP Self-Management (BSM) intervention.21,93,94 This process involved 
gathering information through personal interviews and focus groups of women who had current or past 
histories of BF regarding their needs and preferences for the BSM intervention, their value specifications 
and methods of delivery.19,93,95 The BSM intervention entailed an electronic journal for monitoring BF 
and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support 
and to promote personalized goal setting and problem-solving, hyperlinks to uniform BNP educational 
modules (knowledge and skills) and online resources.21,96
Individual and Family Self-Management of BNP. In an NINR funded pilot RCT study 
(P20NR016605), our research team guided by the Individual & Family Self-Management Theory 
innovatively utilized the BSM intervention. The Individual & Family Self-Management Theory 
conceptualizes self-management as a process in which women use knowledge, beliefs, self-regulation 
skills and abilities and social facilitation to manage their BNP and achieve BF goals (Figure 1). Self-
management occurs in the context of risk and protective factors specific to BF, including pain 
sensitization, frequency of pain specific SNPs, the physical and social environment, and individual and 
family factors. Using self-management process factors of knowledge, and beliefs (pain, BF, and maternal 
self-efficacy), self-regulation skills and abilities (latching, positioning, nipple care, identifying signs of 
Candida or Staph infection), and social facilitation to achieve health-related outcomes.75,76 Pain self-
management is pivotal to women’s BF success as measured by the proximal and distal outcomes. 
Proximal outcomes are acute and cumulative BNP intensity and interference and BF duration, use of 
analgesics and non-pharmacological therapies, and maternal well-being (anxiety, fatigue, depressive, and 
stress symptoms). Distal outcomes are related to the success of the proximal outcomes and include 
exclusivity and duration of BF, and perceived well-being. These outcomes meet the recommendations of 
optimal maternal health during the fourth trimester of pregnancy and maternal-infant health goals by 
national and clinical agencies.45,85,87,97–100 Our structured theory driven BSM intervention targets self-
management process factors especially during the 2-3 weeks of BF initiation when women value 
affirmation and guidance,18,48,101 and knowledge and skills to manage BNP.25,26,74,102,103   
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BSM intervention utilizes proven interventions for BF self-efficacy and BF duration. BF self-
efficacy educational 
interventions provide 
standardized and best 
practice knowledge 
and skills to facilitate 
positive thoughts and 
maternal self-efficacy 
for BF exclusivity.104–
106 Women who 
received antenatal BF 
education, Baby-
Friendly Ten Steps 
based lactation support 
after delivery and have 
multiple contact points 
(4 to 8 targeted 
structured 
interventions) using BF 
journals, web-based or 
face-to-face interactions 
reported greater BF 
self-efficacy, decreased 
depressive symptoms and 
fatigue, and higher BF rates at 1 and 2 months.25,26,107–112 These interventions are effective if best 
practice is followed,113 but costly and difficult to integrate into the fourth trimester care of women in the 
clinical or public health setting, thus wider dissemination outside of clinical trials has been limited.114,115 
A less intensive but effective intervention for women of child-bearing age and in diverse populations is 
text-based communication, which targets BF education.28,30,114 However, although effective, these BF 
self-efficacy interventions have not addressed women’s daily experience of BNP with BF or the presence 
of ongoing postpartum pain.13,18,30,101,112 BF interventions have also ignored BNP and BNP molecular 
risk as a pathway to self-efficacy, increased BF self-efficacy scores are related to decreased report of 
BNP.19,72 Women are clear that with increased pain, there is a decrease in BF self-efficacy and a higher 
rate of early BF cessation.6,19 Our intervention innovatively targets BNP self-management as a pathway 
to build self -efficacy and addresses a critical need of women at home through text-based communication 
and cloud
based modules.
Pilot study results from our research team.22 The pilot study lasted 6 weeks with 83% of the eligible 
women approached consented and mirrored the Connecticut diversity population.4,22,116 Women were 
excluded with a risk of altered pain sensorium such as a chronic medical condition or taking prescription 
medications. Women were randomized by age and delivery, and 92% of women provided data at baseline, 
1, 2, and 6 weeks. At 6 weeks, 87% of women were BF compared to the national average of 79%, with no 
significant difference in diversity or parity.4 Women randomized to the BSM intervention, compared with 
the attention group, reported significantly decreased BNP at 1 and 2 weeks; decreased pain interference 
scores at 1 week predicted increased BF self-efficacy scores and increased BF self-efficacy scores 
positively correlated with exclusive BF at 6 weeks.22 At week 6, increased BF self-efficacy scores 
significantly predicted maternal well-being outcomes of anxiety and sleep disturbances, aligning with the 
literature.22,29,86,117–120 The proposed study will build on our strong pilot results and extend the 
Figure 1. Individual and Family Self-Management Theory for BNP
Protective and Risk 
Factors of Breastfeeding 
Pain
Proximal Outcomes
Distal 
Outcomes
The Self-Management 
Process
Knowledge & Beliefs
•
Pain and breastfeeding self-
efficacy
•
Maternal perception of 
breastfeeding experience and 
milk supply
Self-Regulation Skills & Abilities 
•
Breastfeeding goals
•
Monitoring breastfeeding 
frequency and duration
•
Problem solving breastfeeding 
pain
Social Facilitation
•
Lactation social media support
•
Lactation support –
Professional, family or friend
Breastfeeding Self-Management Intervention
Adapted with permission from Individual and Family Self-Management Theory, by P. A. Ryan and K. J. Sawin retrieved from www.nursing.uwm.edu/smsc. Copyright 2009, 
2014 by Ryan and Sawin.
Health Status
•
Exclusivity of 
breastfeeding
•
Breastfeeding 
duration
Quality of Life
•
Perceived 
well-being
•
Bonding
•
Maternal Self-
efficacy
Individual & Family Self 
Management Behaviors
•
Breast, nipple and 
general pain intensity 
and interference
•
Breastfeeding 
frequency
•
Pharmacological and 
non-pharmacological 
therapies
•
Maternal Well-being: 
Anxiety
Depressive 
symptoms
Fatigue
Stress
Breastfeeding Specific Factors
•
Personal history of 
breastfeeding
•
Medical history
•
Pain sensitivity and coping
•
Candidate pain sensitivity 
and lactation genes and 
DNA methylation
Physical & Social Environment
•
Professional lactation care
•
Baby-Friendly Hospital
Individual & Family Factors
•
Family structure and function
•
Familial history of 
breastfeeding
•
Infant characteristics
Figure 1. Individual and Family Self-Management Theory
Aim 1
Aim 4
Aim 2
Aim 3
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outcome measures to 24 weeks. We anticipate that compared to the attention control group, the BSM 
intervention group will increase BNP and general body pain management, reduce BNP intensity and 
interference, and exceed national BF exclusivity rates at 6, 9, 12, 18 and 24 weeks. We postulate that 
decreasing BNP will increase BF self-efficacy, maternal well-being, and maternal self-efficacy to care for 
their infant.12,15,72,121 The proposed study will explore the occurrence of BNP beyond BF initiation, and 
barriers to BF including maternal return to work and sustaining milk supply by pumping.
Rationale to target biobehavioral mechanisms of BNP in the self-management intervention. It is 
logical that a subset of women experiences greater levels of pain intensity based on the presence of 
genetic polymorphisms of pain sensitivity genes (risk alleles),14 however, this has not been 
systematically studied in BNP during BF. Genetic risk factors (pain sensitivity single nucleotide 
polymorphism (SNPs)) increase vulnerability to peripheral and central pain sensitization and increase the 
likelihood of early BF cessation.10,11,122,123 Oxytocin receptor gene (OXTR) is emerging as having a 
moderating role in pain sensitivity and pivotal to maternal milk supply.9,36,124–126 In our pilot study, 
women with an OXTR SNP minor allele (rs53576), and not catechol-o-methyltransferase (COMT) alleles 
reported increased mechanical pain sensitivity at baseline, and experienced significantly greater BNP at 
two weeks, and those with minor allele rs2254298 were more likely to experience allodynia.31 The 
presence of the minor allele relationship to increased pain may have an indirect effect on duration of 
labor, breast milk supply, and BF exclusivity.9,64,122 In addition, differences in the DNA methylation of 
OXTR rs53576 are predictive of postpartum depression, social attachment, and psychological resources 
across the lifespan.32,127–129 The proposed study will build on the pilot RCT exploration of the effect of 
COMT and OXTR SNPs on BNP, BF and response to the BSM intervention and explore a subset of 40 
participants (5 zero and 15 highest pain phenotype per group) whole genome bisulfite sequencing 
(WGBS) to evaluate DNA methylation of within COMT, OXTR, and other pain genes based on 
preliminary evidence of differential expression associated with a specific pain phenotype. 32,36,130,131 In 
addition to providing high quality data to explore a BNP phenotype, WGBS also provides the opportunity 
to explore the methylation status of OXTR, PRL and PRLR and to evaluate methylation for adequate 
maternal milk supply. So, while the present study will assess only some of the data produced by WGBS, 
the addition of OXTR, PRL and PRLR DNA methylation will provide a useful source of data for 
subsequent hypothesis testing and hypothesis generation connecting pain sensitivity to maternal milk 
supply (Please see amendments of Amoo ISONG grant and Lucas UConn grant).36,132,133 Therefore, the 
integrated approach we have taken in the design of the BSM is supported by previous research 
findings, as well as our pilot study. 
Somatosensory measurement of pain sensitivity and BNP. Extending these findings, our pilot study 
showed that peripheral and central sensitivity of BNP may be objectively measured using 
somatosensory quantitative sensory testing.31 By characterizing each woman’s pain sensitivity profile 
and intrinsic ability to dampen pain (conditioned pain modulation), we may be able to determine the 
precise mechanisms affected by the selected risk alleles. Moreover, these data will contribute to an 
objective understanding of pain variability in women who are initiating BF, and the influence of pain self-
management on BNP.134 In our pilot study, we found women reported greater sensitivity to 
mechanical pressure similar to women with breast cancer pain.31,135,136 Women in our pilot RCT with 
greater sensitivity reported higher levels of pain interference, pain sensitivity and was predictive of BNP 
at 1 and 2 weeks. To date, only one case study evaluated somatosensory pain sensitivity using mechanical 
pain thresholds and found women with increased breast tissue pain sensitivity had an increased risk of 
chronic pain.71 Ongoing BNP with BNP sensitivity may potentially influence future risk of comorbid pain 
disorders and chronic pain.71,137–139 Quantitative sensory testing will examine pain sensitivity as an 
important contextual factor of pain self-management within 48 hours after birth, at 6 weeks when 
postpartum discomfort has resolved and at 6 months to assess the effect of the BSM intervention. 
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Implications for women’s pain across the lifespan. Although BNP has not been recognized as a formal 
“pain” condition,74,139  it is considered to be high impact because BNP can interfere with BF outcomes, 
persist throughout the postpartum period, affect maternal well-being and affect the lifelong health of 
women and infants.2,3,15,140,141 In our pilot study, women in the control group reported significantly 
higher BNP cumulative pain and anxiety at all data points which affects pain perception as seen in other 
clinical pain conditions.141–147 Of concern is that women over their lifetime, experience greater pain 
sensitivity than men and are predisposed to clinical and chronic pain conditions.74,148 This variation in 
pain experience is complex and related to pain sensitivity, genomic factors, psychological and social well-
being but has not been connected to BNP.11,32,134,148,149 Together, women are more at risk for chronic 
pain conditions and increased use of opioids, with perinatal women considered a vulnerable population 
requiring additional clinical oversight during the fourth trimester.74,85,99,150  
The rationale for the timing of data collection at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. In the 
proposed RCT, the BSM intervention will begin the first week after birth, when women shelter at home to 
BF, and have access to a smart phone, thus providing women with standardized and best practice BF and 
BNP problem-solving skills during an acute period of pain when the rate of BF cessation is the 
highest.15,113 In our pilot study, we found statistically significant and clinically meaningful differences in 
pain intensity at 1 and 2 weeks and pain interference as predictive of BF self-efficacy at 6 weeks between 
groups, especially among women with increased pain sensitivity at baseline.22 Thus, the second and third 
weeks are an important period for assessing the length of time needed for the BSM intervention to support 
the women’s use of knowledge and skills for BNP self-management and its impact on proximal and distal 
outcomes. The 6, 9-, 12-, 18-, and 24-weeks data points will allow us to extend our study, explore the 
effect of the intervention on maternal well-being, and DNA methylation of pain sensitivity SNPs on 
decreased BNP and BF exclusivity. All of the data points (baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks) 
align with the national BF duration metrics and the duration of BF recommended by clinical agencies 
(WHO, CDC, ACOG, AAP, AWHONN).4,45,100,151 These nine data points will allow us to describe the 
impact of the BSM intervention on women’s BNP intensity and interference, the risk of early BF 
cessation, the occurrence of BNP after BF initiation and the risk profile of acute to chronic pain. 
Innovation
The proposed project is innovative in the following respects: 
1) Our study will be the first to test a theoretically based BF and pain self-management intervention 
designed for women experiencing BNP during the critical first weeks of BF initiation. The assessments of 
pain intensity, pain interference and pain sensitivity in BF women, as well as the intervention 
components, are aligned with the biopsychosocial model of pain, one of the most widely cited models for 
understanding the cogent variables that influence pain perception and pain outcomes.75,152
2) The proposed study is novel for lactation science to measure the biobehavioral variables that affect BF 
outcomes including measurement of pain sensitivity using quantitative sensory testing and pain genomics 
(selected pain sensitivity SNPs and DNA methylation), influence on BF exclusivity. 
3) The intervention delivery platform uses a patient-centered approach based on user needs (information) 
and preferences (texting) for incorporating the intervention into their daily lives.153,154 The project targets 
the critical window of 1-3 weeks after BF initiation when BNP and BF cessation risk is highest.6,47 
4) The delivery of the intervention is via mobile technology accessible to women in their home, during 
the time of BF initiation when support is most valued and in which face-to-face visits are most 
burdensome and places the mother-infant dyad at risk for illness, such as COVID-19.28,101,154 
5) The PROMPT study novelty is using the BSM intervention to identify the personal risk and protective 
factors of BNP, which holds great promise for 1) precision interventions for BNP, as well as the 
replication and extension of our pilot study findings with pain sensitivity polymorphisms (COMT, OXTR) 
and DNA methylation roles in BF pain and maternal well-being, and the development of easily accessible 
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strategies for women BF within clinical settings that allow for large-scale translation in health care 
systems and public health settings.
Approach 
To examine the efficacy of the BSM intervention in BF women on BNP intensity and interference and BF 
outcomes, we have designed an RCT with two groups: the BSM intervention and attention control group. 
An attention control group was selected to control the influence of daily reflection and bi-weekly 
attention for participants in the BSM intervention group.155 The self-management measures of the study 
were selected based on the Individual & Family Self-Management Theory pilot work by the PI regarding 
management of BF. Our team includes Drs. Lucas (PI), Henderson, and Walsh collaborated on the 
design of the longitudinal intervention based on their expertise in conducting longitudinal studies with 
maternal-infant populations.22,31,156 Dr. Henderson is an expert in maternal child health and with 
genomic, clinical, and translational methods that are predictive of pain phenotypes. Dr. Steve Walsh, 
statistician, is an expert related to study design, data collection, data management, and statistical 
analysis. Dr. Young, geneticist at the University of Kansas Medical Center, is a long-time collaborator 
and is an expert in quantitative sensory testing in human subjects, molecular/genetics methodologies and 
design/implementation/statistical analyses of behavioral and genetic data on the molecular genetics of 
pain.31,157,158 Dr. Lucas, together with the Co-Is developed the current and evolving exploration of BF 
and BNP as a biobehavioral phenomenon.21,22,31 In particular, Dr. Lucas’ pilot work (P20NR016605) 
tested the feasibility of the BSM intervention in several clinical settings with long standing relationships. 
The research and clinical team bring together the experience needed and through bi-weekly meetings 
which transitions to weekly meetings in which Dr. Lucas will provide oversight of study milestones. The 
proposed PROMPT RCT expands the PI’s pilot study to test the BSM intervention in a larger sample for 
efficacy testing. 
There are three sub study attachments that explore additional questions based the data collection. The first 
attachment is the Lucas Seed Grant OXTR and Maternal milk supply which with additional funding, will 
explore the relationship of DNA methylation of OXTR in pain insensitivity and maternal milk supply (see 
funded grant attachment).  A second amendment is for Tumilara Amoo, graduate student at UConn 
School of Nursing and key personnel on the study, who will explore the role of prolactin receptors related 
to milk insufficiency for her funded dissertation (see ISONG funded grant and attachment). The third 
attachment is for Rachel Hage, key personnel on the study and honors student at UConn, will use the 6- 
and 24 – week interviews to explore how text-linked modules on infant development help maternal self-
efficacy in taking care of their infant children.
1. Preliminary Studies
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1.1. Recruitment and retention of women initiating BF. Dr. Lucas has conducted biobehavioral studies 
of BF using multiple methods. Dr. Lucas adjusted the number of women approached to fulfill the planned 
enrollment based on infant gestation and study burden.159 For telephone and the text-based study designs, 
a 10 – 20% increase of the planned 
enrollment met the sample size with a 90% 
retention of participants at 4 weeks with peak 
attrition at 2 weeks.156,160 Videotaping 
preterm and full-term infants BF and testing a 
BF diagnostic device prototype in the home 
required a 100% increase of the planned 
enrollment with an 80 – 85% retention of 
participants at 4 weeks and peak attrition after 
1 week.95,161 The pilot RCT used text 
communication, email, telephone contact and 
increasing monetary incentives to retain 94% 
of participants with peak attrition in 1 week.22 
1.2. Randomized control trial using the 
BSM Intervention to decrease BNP. The PI 
completed an RCT pilot study 
(P20NR016605, PI: Starkweather) to test the 
feasibility of the BSM intervention on pain 
intensity and BF frequency and BF exclusivity and 
to identify somatosensory and genetic factors that 
place women at risk for BNP phenotype.22,31 Our 
team conducted the pilot RCT at two clinical sites 
within four months including on-site data 
collection, web-based data entry, and follow-up 
text-based communication with participants (n = 
65) resulting in a 94% participation retention 
rate.21,22 The BSM intervention group reported 
significantly lower BNP using a visual analogue 
scale (0 - 100) at 1 and 2 weeks. Participants’ 
cumulative BNP (baseline +1 week, + 2 week, + 6 
week, 0 - 400) was significantly different between groups at weeks 1, 2, and 6 (Figure 2). Higher Brief 
Pain Inventory interference scores at 1 week was predictive of increased BF self-efficacy scores at weeks 
1, 2, and 6. Aligning with the literature BF self-efficacy scores correlated with BF exclusivity and at 6 
weeks significantly predicted maternal well-being symptoms.29,86,117 Women experienced an 8.18 
increase in BF and BNP scores over time with the minor allele A of rs53576 (Figure 3). The 
somatosensory testing results also showed that for every 1-unit increase in the Mechanical Detection 
Threshold test, women experienced 16.51 higher BNP scores and 4.82 higher BNP scores for the Windup 
Ratio. Six women with the OXTR rs2254298 minor allele experienced allodynia sensitivity.31 These risk 
factors will be examined in the larger study to determine replicability. The effect of the components of the 
BSM intervention on BNP were examined independently without significance which demonstrates the 
importance of a multifactorial approach. Participants’ feedback of the BSM intervention included that 
texting was helpful while the paper-based daily journal was burdensome. All participants reported that the 
weekly survey completion was not burdensome.  
1.3. Maternal Assessment of Infant BF Behaviors. Over 4 weeks, 115 BF women (38 late preterm and 
77 full term) described their infants’ BF behaviors which the PI analyzed using a breastfeeding 
Figure 3. BNP for OXTR rs53576
Figure 2. Cumulative BNP at 1, 2, and 6 Weeks Using a 
Visual Analogue Scale (0 - 100)
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 9 of 42
algorithm162,163 and coded video recordings of a subsample of 27 infants (7 late preterm and 20 full term) 
jaw movements during BF. Using logistic discriminant analysis, 4 clusters of BF behaviors were 
identified (under preparation). 
Together, the preliminary work provides evidence of the PI’s ability to recruit and retain women in 
longitudinal studies that examine BF biobehaviors and to test the BSM intervention, as well as her 
motivation and dedication to maintaining a productive program of research. For this proposal both data 
collection and analysis will be facilitated by the contributions of her Co-Is. The University of Connecticut 
School of Nursing (UConn SON) offers a supportive environment for Dr. Lucas to carry out the study, 
including reserved laboratory space and portable equipment. Her solid collaborations with the study sites 
will ensure ample enrollment of a diverse sample of women, with efficient attainment of study milestones 
and dissemination of findings. 
Participant Population 
The sample size objective for the study is to recruit N = 280 women who will be randomly assigned to the 
BSM or attention control study groups at a 1:1 ratio (140 per group). The BSM intervention is designed for 
all women who initiate BF since both primiparas, and multiparas are affected (naivety or anticipatory 
based on prior BF experience) by some degree of pain.19,43,56,68,164 As it is not possible at this time to 
identify women at risk of early BF cessation due to pain or enhanced pain sensitivity, it is expected that 
the higher number of women in the BSM group will continue BF over the study duration. 
Enrollment and Randomization 
After informed consent and prior to the start of data collection, the participants will be 
randomized to the BSM intervention or the attention control group and be assigned a unique 
participant identification number (PID#). The sample size objective for the study is to recruit N = 
280 women who will be randomly assigned to the BSM or attention control study groups at a 1:1 
ratio (140 per group).  Random assignment will be performed using an established dynamic 
minimization algorithm, proposed by Pocock and Simon 165 . The algorithm is implemented thru 
an R package called “minirand”, developed by Jin et al. 166. The interactive tool is developed as 
an R shiny app embedded in REDCap. This technique will maintain the 1:1 ratio between 
participants assigned to the BSM and control conditions, but will also ensure that participant 
characteristics that are known to be predictive of breastfeeding outcomes will each be balanced 
across the study groups.  Those predictive characteristics include: age, race, breastfeeding 
experience, expected breastfeeding duration, route of delivery, and intent to return to work.
The reason we choose this algorithm is the complexity of the randomization needed for our 
study. With 280 expected participants and 6 stratifying characteristics, the simple randomization 
may not yield a balanced arm assignment in every allocation. However, the dynamic feature of 
our randomization will incorporate both the existing assignments and the imbalance at each level 
of the stratifying characteristics and assign the next participant to minimize the overall 
imbalance. With the large number of total enrollments in our study, this also leads to a balanced 
assignment at each level of the stratifying characteristics. To retain randomness, the probability 
of making the “best assignment” to minimize imbalance is set to be 90%.
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 10 of 42
The randomization algorithm will be implemented in REDCap using published code that 
operates within “R” statistical software.  An interface between REDCap and R software will be 
created by the project statisticians as a “Shiny app” within the RStudio development 
environment.  The resulting R Shiny app will allow the project’s recruitment staff to enter the 
predictive characteristics for a new participant, will compare the new participant’s mix of 
characteristics to those of current participants, and will produce a “blinded” study group 
assignment for the new participant.  The blinded group assignment will be presented to the 
recruitment staff as one of four letters: A, B, C, or D.  That letter will then be entered into 
REDCap as the new participant’s record is set-up.  REDCap will be programmed to link each of 
the four letters to a study group (two letters for the BSM group and two others for the control 
group).   Only the project statisticians, the project manager and the graduate assistant will know 
the correspondence between letters and group assignments.  Four letters (and a corresponding 
study “arm” for each one) will be used to make it more difficult for recruitment staff to decipher 
which letters link to specific study groups and, therefore, to foster the likelihood that blinding to 
group assignment will be maintained throughout the project.
Justification of Sample Size:  
The sample size objective for the study is to recruit N = 280 women who will be randomly assigned to the 
BSM or attention control study groups at a 1:1 ratio (140 per group). This objective provides 80% power 
(α =0.05, two-sided) to detect a standardized mean difference (Cohen’s d) of 0.39 or more between the 
BSM and attention control groups. It also provides 80% power to detect an odds ratio of 2.5 or more in 
exclusive BF between the two groups, assuming that the exclusive BF rate of the control group will be 
10% higher than the national population rate in 2017 at 6, 9, 12, 18, and 24 weeks.4 These calculations 
account for “loss to follow-up” as high as 25% at 24 weeks, despite the substantially lower attrition (6%) 
in our pilot study. Based on our pilot study, we approached 78 women to meet our sample size of 60, with 
a failed screening rate of 25%. Thus, we intend to approach 374 women, which is 25% higher than our 
proposed study sample to meet our sample size.21 We anticipate that approximately 70% of the study 
sample will be WAHS or HHC patients.
In the pilot study, RM-ANCOVAs (with the baseline value of a measure as the covariate) revealed 
standardized mean differences larger than d = 0.39 for the “main effect” of the intervention on BNP 
intensity (d = 0.45), pain severity (d = 0.60), cumulative pain (d = 0.64), and BF self-efficacy (d = 0.48) 
across the 1-, 2-, and 6-week time points.22,147 For BNP interference, the value of d was 0.39 at week 1, 
but smaller at weeks 2 and 6.22 Furthermore, the odds of exclusive BF in the intervention group are 2.9 
times higher than the control group at 6 weeks, which is also higher than the hypothesized OR = 2.5. 
Therefore, we are confident that the sample size goal will be sufficiently powered to detect intervention 
effects on key variables for SA1 and SA2. Finally, the sample size estimate does not reflect our plans to 
conduct analyses based on repeated measurement of outcome variables at the 1, 2, 3, 6, 9-, 12-, 18-, and 
24-week time points (due to the dearth of information regarding 24-week outcomes). Generally, the 
inclusion of data for an outcome variable across additional time points marginally enhances statistical 
power, especially for testing “main” and “interaction” effects of intervention and time.167
Enrollment of Employees: 
Employees or Hartford Hospital Employees may be recruited if they receive clinical care from Women’s 
Ambulatory Center, or private obstetric care at Hartford Hospital or UConn Health Center. We will not 
recruit any women who report to key personnel.
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 11 of 42
Enrollment of Key Personnel, Spouses or Dependents/Relatives:  
We will not recruit key personnel, spouses of key personnel, or dependents/relatives of any key personnel.
For EACH Participant Population Describe Screening Procedures, if applicable 
The proposed RCT will be conducted to test the effect of the BSM intervention vs. an attention control 
group on BNP, BF exclusivity and duration, BF self-efficacy and maternal well-being to 24 weeks 
(Figure 4). Participants at baseline will complete assessments, quantitative sensory testing, and provide 
buccal cell and/or blood samples for assessment of select pain sensitivity SNPs and DNA methylation and 
again at 6 and 24 weeks at our research sites. At 1, 2, 3-, 9-, 12-, and 18-weeks participants will complete 
assessments via smartphone text and the UConn Health Research Electronic Data Capture (UConn 
REDCap) links, https://health.uconn.edu/clinical-researchcenter/ when women shelter at home. If a 
participant does not have a smartphone, the study will provide a smartphone for them to receive texts and 
text links. All participants will receive educational material regarding infant development and age-
appropriate play at 4, 8, 12, 16, 20, and 24 weeks to maintain contact and sustain engagement in the 
study.168 Following UConn Institutional Review Board approval, all recruitment and initial data 
collection will occur in collaboration with our clinical partners, at the UConn Health Center, a 234-bed 
tertiary care academic hospital delivering 700 infants a year with 560 women initiating BF; the Women 
Ambulatory Services at Hartford Hospital (HH), delivering 1000 infants a year with 800 women of 
diversity initiating BF (see letters of support) and women receiving private obstetric care at Hartford 
Hospital, delivering 2900 infants a year with 2320 initiating BF.
Prior to launch of the study, all research personnel will receive training on human subjects’ research, 
HIPAA, and biological safety, handling and transportation. The study designated graduate assistants will 
develop a study binder of all protocols and each role will be established so that appropriate blinding 
procedures can be maintained throughout the study duration. Dr. Lucas and the project manager will train 
all research personnel (graduate assistants, research assistants, and peer counselors) on the standardized 
intervention, scripts, protocols for women who need referrals or follow-ups for BF support or maternal 
well-being, documentation of schedule data collection visits, and establish weekly research team 
meetings.
Anticipated Study Time Frame: 
Recruitment will begin in October 2021 and continue through December 2024. 
Design, Procedures, Materials and Methods: 
The proposed RCT will be conducted to test the effect of the BSM intervention vs. an attention control 
group on BNP, BF exclusivity and duration, BF self-efficacy and maternal well-being to 24 weeks 
Research activity/Quarter
Year 1
Year 2
Year 3
Year 4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
Start-up, 
team, 
training, 
IRB 
approval
X
X
Subject 
enrollment 
in 
Y1=50, 
Y2=110, 
Y3=110, 
Y4=10;
Data 
collection; Data quality management
X
X
X
X
X
X
X
X
X
X
X
X
Complete follow-up
X
X
X
X
X
X
X
X
X
X
X
X
X
Presentation at conferences
X
X
X
X
X
Submission of protocol and interim 
analysis article 
X
X
X
Complete database; Final analyses; 
Grant preparation, Final report
X
X
X
X
X
X
X
X
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 12 of 42
(Figure 4). Participants at baseline will complete assessments, quantitative sensory testing, and provide 
buccal cell and/or blood samples for assessment of select pain sensitivity SNPs and DNA methylation and 
again at 6 and 24 weeks at our research sites. At 1, 2, 3-, 9-, 12-, and 18-weeks participants will complete 
assessments via smartphone text and the UConn Health Research Electronic Data Capture (UConn Health 
REDCap) links, 
https://health.uconn.edu/clinical-researchcenter/ when women shelter at home. If a participant does not 
have a smartphone, the study will provide a smartphone for them to receive texts and text links. The 
consent will inform the participant that if the phone is lost before the participant withdraws or attends the 
6-month research visit, $75 will be deducted from the remuneration for their 6-month visit. All 
participants will receive educational material regarding infant development and age-appropriate play at 4, 
8, 12, 16, 20, and 24 weeks to maintain contact and sustain engagement in the study.168 Following UConn 
Institutional Review Board approval, all recruitment and initial data collection will occur in collaboration 
with our clinical partners, at the UConn Health Center, a 234-bed tertiary care academic hospital 
delivering 700 infants a year with 560 women initiating BF; and the Women Ambulatory Services at 
Hartford Hospital (HH), delivering 1,000 infants a year with 800 women of diversity initiating BF (see 
letters of support) women receiving private obstetric care at Hartford Hospital, delivering 2900 infants a 
year with 2320 initiating BF.
Prior to launch of the study, all research personnel will receive training on human subjects' research, 
HIPAA, and biological safety, handling and transportation. The study designated graduate assistants will 
develop a study binder of all protocols and each role will be established so that appropriate blinding 
procedures can be maintained throughout the study duration. Dr. Lucas and the study Project Manager 
will train all research personnel (graduate assistants and peer counselors) on the standardized intervention, 
scripts, protocols for women who need referrals or follow-ups for BF support or maternal well-being, 
documentation of schedule data collection visits and establish weekly research team meetings. Dr. Lucas 
and the Project Manager will conduct internal audits every three months to ensure fidelity in recruitment 
and procedures.
Table 1: Timeline of procedures
Week
Day
Measure
Location
Time
Compensation
Prenatal 
visit
Recruitment
Study flyer, Breastfeeding Basic 
Information
HH, WAHS,
UCHC prenatal 
clinic
5 min
$0
0
Recruitment
Initial Screen
Hospital/ Smart 
phone
5 mins
0
Baseline 
Assessment
Consent

Verification of CLC evaluation of 
breastfeeding

Buccal cell swabs and/or blood 
collection (15 ml or 3 teaspoons)

QST
Questionnaires

Demographics

Breastfeeding Specific Factors: 
Maternal and Infant Breastfeeding 
History
Hospital
1 hr
Links 
will be 
shared 
for 
individua
ls to 
$25 UConn 
Greenphire Gift 
Card or ecard
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 13 of 42

Breastfeeding Log (BL)
o
MAIBB-R
o
Algorithm

Breastfeeding Battery (BB)
o
BSES-SF
o
Ongoing Breastfeeding 
Assessment

Pain Interpretation Scales (PIS)
o
Coping Strategies 
Questionnaire
o
McGill Pain Questionnaire
o
Brief Pain Inventory
o
Visual analogue scale

Maternal Well-Being (MWB)
o
NINR CDEs (Anxiety, Sleep, 
Fatigue, Perceived Stress 
Scale, Index of Self-
Regulation, Self-Efficacy for 
Managing Chronic Illnesses 
Scale, Global Health)
o
EPDS
o
Karitane Parenting 
Confidence Scale
complete 
on their 
own
1
Days 1-5
Intervention Group ONLY: 
BL: 1 entry/ day 
Texts 2 times/ week breastfeeding 
coaching with links to 
Breastfeeding Modules 1-3
Maternal/Infant Care Modules 1-2
Personal 
computer/ 
smartphone
5 mins 
per entry
10 mins/ 
module
Days 1-5
Control Group ONLY: 
Texts 2 times/ week with links to
Maternal/Infant Care Modules 1-2
Personal 
computer/ 
smartphone
10 mins/ 
module
Day 5
Both Groups: BB, PIS, MWB
Control Group only: BL
Personal 
computer/ 
smartphone
10 mins
$25 UConn 
Greenphire Gift 
Card or ecard
2
Days 8-12
Intervention Group ONLY: 
BL: 1 entry/ day
Texts 2 times/ week breastfeeding 
coaching with links to 
Breastfeeding Modules 4-6
Maternal/Infant Care Modules 3-4
Personal 
computer/ 
smartphone
5 mins 
per entry
10mins/ 
module
Days 8-12
Control Group ONLY: 
Texts 2 times/ week with links to 
Maternal/Infant Care Modules 3-4
Personal 
computer/ 
smartphone
10 mins/ 
module
Day 12
Both Groups: BB, PIS, MWB 
Control Group only: BL
Personal 
computer/ 
smartphone
10 mins
$25 UConn 
Greenphire Gift 
Card or ecard
3
Days 15-19
Intervention Group ONLY:  
BL: 1 entry/ day
Personal 
computer/ 
5 mins 
per entry
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Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 14 of 42
Texts 2 times/ week breastfeeding 
coaching with links to 
Breastfeeding Modules 7-9
Maternal/Infant Care Modules 5-6
smartphone
10mins/ 
module
Days 15-19
Control Group ONLY:  
Texts 2 times/ week with links to 
Maternal/Infant Care Modules 5-6
Personal 
computer/ 
smartphone
10 mins/ 
module
Day 19
Both Groups: BB, PIS, MWB 
Control Group only: BL
Personal 
computer/ 
smartphone
10 mins
$25 UConn 
Greenphire Gift 
Card or ecard
Weeks 
4-6
Days 21-40
Intervention Group ONLY: 
BL: 1 entry/ day
Texts 2 times/ week breastfeeding 
coaching with links to 
Maternal/Infant Care Modules 7-12
Personal 
computer/ 
smartphone
5 mins 
per entry
5 mins/ 
module
Days 21-40
Control Group ONLY:  
Texts 2 times/ week with links to 
Maternal/Infant Care Modules 7-12
Personal 
computer/ 
smartphone
5 mins 
per entry
Week 4
Day 26
Both Groups
Infant development and play modules 
at 4 weeks
Personal 
computer/ 
smartphone
10 mins
Week 6
Day 40
Both Groups: 

Buccal cell swabs and/or blood 
collection (15 ml or 3 teaspoons)

QST

BL

BB, PIS, MWB

Audio taped semi-structured 
interview: Reflection on 
participating in the study and the 
impact on their breastfeeding 
outcomes
Clinic, 
smartphone
60 mins
15 mins
$50 UConn 
Greenphire Gift 
Card or ecard
Week 8
Day 54
Both Groups
Infant development and play modules 
at 8 weeks 
Personal 
computer/ 
smartphone
10 mins
Week 9
Day 61
Both Groups: BB, PIS, MWB, BL
Personal 
computer/ 
smartphone
10 mins
$35 UConn 
Greenphire Gift 
Card or ecard
Week 12
Day 82
Both Groups: BB, PIS, MWB, BL
Infant development and play modules 
at 12 weeks
Personal 
computer/ 
smartphone
10 mins
$35 UConn 
Greenphire Gift 
Card or ecard
Week 16
Day 110
Both Groups
Infant development and play modules 
at 16 weeks
Personal 
computer/ 
smartphone
10 mins
Week 18
Day 122
Both Groups: BB, PIS, MWB, BL
Personal 
computer/ 
smartphone
10 mins
$35 UConn 
Greenphire Gift 
Card or ecard
Week 20
Day 138
Both Groups
Infant development and play modules 
Personal 
computer/ 
10 mins
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Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 15 of 42
Procedures and Data Collection at each Time Point. 
At baseline we will collect demographic information, pain and coping scales, BF measures, maternal 
well-being symptoms, pain, BF and maternal self-efficacy scales, and quality of life health status.  
Subsequently, quantitative sensory testing will be performed on the non-dominant forearm and a buccal 
cell and/or blood samples will be obtained for analysis of selected pain sensitivity SNPs and DNA 
methylation. All buccal cell swabs and/or blood (15 ml or 3 teaspoons) samples will be labeled with the 
participants’ identification number. Blood will be kept at room temperature on the clinical unit and during 
transport, and buccal swabs will be stored in a freezer on the clinical unit at -20 degrees Fahrenheit, until 
transported to the SON Biobehavioral Lab (BBL) for processing and storage. 
Study questionnaires will be administered via electronic surveys using UConn Health REDCap v11 
Participant will access the UConn Health REDCap link before discharge to access and view texts, web 
links, and the video modules on either handheld device (e.g., smartphone, iPad) or computer 
desktop/laptop. All participants will receive an encrypted text (via UConn Health REDCap with an 
embedded link from Twilio) or an email per their preference with the study measures via UConn Health 
REDCap v11 After the initial surveys are completed, participants will be asked to contact a member of 
the research team to register their Greenphire incentive card. A member of the research team will 
complete the Greenphire form which includes social security number (field is encrypted), address, email 
and phone number to initiate the first incentive payment. The PROMPT study does not retain 
participant’s social security number or address in our records. If the participant does not have a social 
security number, ecards will be provided by UConn School of Nursing business office. The team member 
will also refer the participant to WAHS and Outpatient Lactation scheduler or the UConn Health 
scheduler for the 6 week follow up visit.
Intervention Administration. Each group will receive a link to the eight video modules between 3-`5 
minutes long that address a different topic. During the first week, the appropriate link to the first video to 
the BSM intervention and attention control group will be sent. Intervention fidelity will be addressed 
using Resnick et al’s174 framework of design, training, delivery, receipt, enactment, which will be 
continuously assessed throughout the study duration. Design fidelity will be applied through a 
standardized intervention with scheduled interactive texts, text-based daily BF journals and links to 
modules. Training of the interventionist(s) will be assessed routinely by Dr. Lucas through simulated 
scenarios and practice sessions using texting and phone scripts. Evidence of treatment will include 
participants’ response to bi-weekly texts and targeted lactation support based on galactogenesis and 
lactation milestones.21,27 The research team will monitor intervention fidelity by using the UConn Health 
at 20 weeks
smartphone
Week 24
Day 166
Both Groups: 

Buccal cell swabs and/or blood 
(15 ml or 3 teaspoons) collection

QST

BL, BB, PIS, MWB

Audio taped semi-structured 
interview: Reflection on 
participating in the study and the 
impact on their breastfeeding 
outcomes

Infant development and play 
modules at 24 weeks
Clinic, 
Interview, 
smartphone
60 mins
15 mins
$75 + $25 
bonus UConn 
Greenphire Gift 
Card or ecard
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
IRB APPROVAL DATE: 04/11/2023

Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 16 of 42
REDCap feature that will allow research team to view the date, time, length, and number of times the 
participant accesses each module and completes the daily BF journal. Our Project Manager, blinded to 
initial randomization, will coordinate the research team to send participants texts, follow-up phone calls, 
and emails as needed, at 1, 2, 3, 9, 12, and 18 weeks to encourage completion of the modules and for 
BSM intervention, address any BF concerns. After the first week, depending on the participant’s 
preference, encrypted text messages, phone calls and/or emails will be made by the research team to 
encourage BF data completion. 
Data Collection during Follow up. After discharge, both groups will receive an encrypted text via 
UConn Health REDCap with embedded links from Twilio, a cloud communications platform and a back-
up archive feature. The follow-up measures at 1, 2, 3, 9, 12, and 18 weeks (Figure 4) include the 
participants’ weekly BNP, pain coping, BF exclusivity, ongoing BF assessment, BF algorithm and 
maternal assessment of infant BF behaviors, self-efficacy scales (pain, BF, and maternal), maternal well-
being assessments, and perceived well-being scales. Completion of the measures will take about 30 
minutes. Our statistician team at weekly meetings will identify any missing data to facilitate contact of  
participants to complete surveys. At 6 and 24 weeks, participants will complete the above measures and 
repeat quantitative sensory testing and provide buccal cell and/or blood samples for selecting pain 
sensitivity SNPs and DNA methylation at our clinical locations. Completion of the measures will take 
about 60 minutes. At Weeks 4, 18 and 20, participants will receive a prompt in their modules to provide 
their 6 week and 6-month research appointment day and time. If participants do not provide a date and 
time, research personnel will reach via text (up to three times) to schedule the appointment.
Blinding. We will employ blinding whenever possible. The PI and all sthe research team members 
involved in data collection or analysis will be blinded to the randomization of the participants, and some 
of the research team to the group assignment of participants.  The statisticians, project manager and 
graduate assistant will not be blinded to study assignment and ongoing data collection.  Research team 
personnel will follow a strict script to refrain from discussing participant activities, and by using the data 
management graduate assistant (unblinded) to coordinate assigned condition activities and data collection 
and analysis. All participants will be assigned a study number, which will be used to track the study 
measures and buccal cell and/or blood samples. De-identified data with dummy-codes for assigned 
condition will be entered into the study database to allow blinded data analysis. Blinding was successfully 
employed during our pilot study.
Participant Retention. Participants will receive progressive monetary incentives, and to retain trust,150 
the participants in both groups will receive monthly text links to normal infant development and age-
appropriate play modules.150,175
Measures, survey instruments and questionnaires, (including the collection of demographic data). 
Baseline, Process, and Outcome Measurements (Table 2) 
All of the BNP measures (visual analogue pain scale and Brief Pain Inventory short form), pain coping 
(Coping Strategies Questionnaire), BF specific factors including demographics, ongoing BF assessment 
and algorithm, Breastfeeding Self-Efficacy Scale, maternal assessment of infant BF behaviors, maternal 
well-being symptoms [PROMIS anxiety, sleep, fatigue, perceived stress], Edinburgh Postnatal Depression 
Scale, perceived well-being [PROMIS global health],pain sensitivity SNPs, and quantitative sensory 
testing, were successfully collected in the pilot. The effect of the BSM intervention on pain self-efficacy, 
will be measured by the Self-Efficacy for Managing Chronic Illnesses Scale, the Index of Self-Regulation, 
and on maternal self-efficacy the Karitane Parenting Confidence Scale and Postpartum Bonding Instrument. 
IFSMT Context variables.
HHC-IRB
IRB NUMBER: E-HHC-2021-0143
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Marshall-Crim and Lucas: “Promoting Self-Management of BNP…” revised 12/2/22 
Page 17 of 42
Breastfeeding Specific Factors, Physical and Social Environment, Individual and Family Factors and 
Biomedical Research Informatics 
Computing 
System 
Demographics169–171 
The 
questionnaires will be used to collect participants’ demographics (age, gender, height, weight, 
race/ethnicity, education, socioeconomic and employment status), BF and medical history (parity, prior BF 
experience, route of delivery, baseline BNP knowledge, chronic conditions and medication usage), physical 
and social environment targeting BF support (hospital and home access to professional lactation support, 
and infant and family characteristics).
Pain Sensitivity. Pain and Coping. The Coping Strategies Questionnaire-Revised will assess participants’ 
pain coping strategies (praying, coping self-statement, distancing from the pain, ignoring pain, 
catastrophizing, and distraction). Participants use a 7-point Likert scale to rate the frequency of their use 
of each coping strategy, “never do that” to “always do that” and its perceived control over their pain.172,173 
Scores range from 7-42, with higher scores indicating more frequent use of the coping strategy. 
Peripheral and Central Pain Sensitivity. Peripheral and central sensitivity will be measured using a 
standardized quantitative sensory testing battery of cutaneous mechanical pain sensitivity, involving 
measures of threshold, ratings of suprathreshold stimuli, temporal summation and after sensations, and 
pressure pain thresholds using the participant’s non-dominant forearm.174 The testing battery and 
equipment will match those used by the gold standard German Neuropathic Pain Network.137,175 The testing 
assesses inadequate function (hypoalgesia) as well as gain of function (hyperalgesia) and results are 
evaluated using age- and gender-matched reference data in pain and control populations.175,176 Inter-rater 
reliability of the quantitative sensory testing protocol has been reported in several pain clinical trials, with 
each individual test demonstrating acceptable correlation coefficients.134,175,177–179
Table 2. Individual & Family Self-Management Theory Measures
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Candidate pain sensitivity SNPs genotyping. Blood and/or buccal cell samples will be collected at 
baseline before discharge. Blood will be drawn by trained hospital staff or members of the research team 
before discharge  in the 
patient’s hospital room. At 
the 6 week and 24 week 
follow up, blood will be 
drawn at HH in the lactation 
room. At the follow up 
appointments at WAHS, the 
PROMPT 
research 
team 
member 
will 
escort 
participant to the phlebotomy 
area. At UCHC, the blood 
will be drawn at UConn 
Health BBL or Clinical 
Research 
Center. 
The 
research team will endeavor 
to have the blood drawn 
during routine clinical blood 
draws. 
Samples 
will 
be 
transported to the School of 
Nursing Biobehavioral lab, 
UConn lab service center or 
Dr. Young’s lab to be 
processed, and split, volume 
permitting, for liquid N2 
storage of a white-blood-cell 
pellet for later RNA studies. 
DNA will be isolated using 
the Qiagen DNA Easy Kit 
and QC’d prior to delivery of 
500 ng to the lab service 
centers at the University of 
Connecticut, such as Center 
for 
Genome 
Innovation 
(CGI), Microbial Analysis, 
Resources and Services 
(MARS) or the School of 
Nursing 
Associated 
Laboratories. Samples will 
be batched in groups of 10 for 
processing on The Illumina 
Methylation 
EPIC 
Bead 
Chip.
For 
buccal 
cell 
swabs, 
participants will be instructed 
to rinse their mouth with   
clean water and roll the sterile buccal brush firmly on the inside of both cheeks. The participant will roll 
one brush for 60 seconds on the first cheek and repeat again on the second cheek. Samples will be 
transported to the SON biobehavioral lab and stored at -80°C until processing in batches at a UConn lab 
service center or shipped to Dr. Young’s lab for verification of results. Genomic DNA (gDNA) will be 
isolated from buccal samples using the OMNIgene•ORAL OMR-110). The samples are stable at room 
temperature for 30 days, allowing transport to the SON biobehavioral lab, UConn lab service center, and/or 
Time Points
Module
Item#
α
T1 T2 T3
T4 T5T6T7 T8 T9
Context factors:
Breastfeeding Specific Factors20, 21
BRICS Demographics162-164
Module – FBF
48
N/A
X
X
x
Pain Coping Strategies165-166
Module – DB, GI, C, S
27
0.80-
0.88
X X
x
X
xx
X
x
X X X X X
Quantitative Sensory Testing167-170
13
0.94
X
X
X
Process factors:
Self-efficacy Scale164,172
Module – DB, GI, C, PN-BF, S, 
6
0.91
X X
x
X
xxx
X
x
X X X X X
BF Self-Efficacy Scale173
Module – FBF, BNPS , C, S, CPI
14
0.94
X X
xx
X
x
X
xx
X X X X X
Index of Self-Regulation175,176
Module – BNPS, DB, GI, C, S
9
0.73-
0.76
X X
xx
X
xx
X
x
X X X X X
Ongoing BF Assessment Survey 
Module20,21 – FBF, BNPS , CPI
30
N/A
X X
xx
X
X
x
X X X X X
BF Algorithm156-158
Module – FBF, BNPS, PN-BF
9
N/A
X X
xx
X
x
X
X X X X X
Maternal Assessment of Infant BF 
Behaviors156,157
Module – FBF, BNPS, PN-BF
8
N/A
X X
xx
X
x
X
X X X X X
H&H Lactation Survey182
20
(0.75-
0.98)
X
X
X
X
Proximal outcomes:
PROMIS Anxiety, Sleep, Fatigue, 
Perceived Stress Scales162-164
Module – DB, GI, C, S
6-30
0.79-
0.91
X X
x
X
xx
X
x
X X X X X
Visual Analogue scale (0-100)22
Module – BNPS, PN-BF
1
N/A
X X
x
X
x
X
X X X X X
Edinburgh Postnatal Depression 
Scale181
Module– C, S
10
0.87
X X
X
x
X
x
X X X X X
McGill Pain Scale179,180
Module - BNPS, PN-BF
15
0.96
X X
x
X
x
X
X X X X X
Brief Pain Inventory-SF177,178
Module – BNPS, PN-BF
7
0.77-
0.91
X X
x
X
x
X
X X X X X
Distal outcomes:
Parenting Confidence Scale174
Module – FBF, C, S
14
0.81
X X
x
X
x
X
x
X X X X X
PROMIS Global Physical Health 
and Mental Health162-164
Module – GI, C, S
10
0.81-
0.86
X X
X
xx
X
x
X X X X X
T1 = baseline; T2 = 1 week; T3 = 2 weeks; T4 = 3 weeks; T5 = 6 weeks; 
T6 = 9 weeks; T7 = 12 weeks; T8 = 18 weeks, T9 = 24 weeks
FBF = Fundamentals of BF; BNP-S = BNP strategies; DB = Deep breathing;
GI =  Guided Imagery; PN-BF =  Pain neurophysiology related to BF; 
C =  Catastrophizing; S =  Stress reactivity; CPI =  Common pumping issues
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shipping to Dr. Young’s lab. Genomic DNA SNP genotyping will be completed for six SNPs, COMT (4 
SNPs; (catechol-o-methyltransferase)), and OXTR (2 SNPs) (Table 3) using Taqman SNP genotyping 
assays (VIC/FAM) and allelic discrimination analysis according to manufacturer’s directions using an 
Applied Biosystems StepOne Plus PCR machine and ABI allelic discrimination software (ThermoFisher 
Scientific, Waltham, MA). Dr. Young has verified a < 95% call rate for all SNPs included using 10uL 
samples and manufacturer’s running parameters. 
Whole Genome Methylation Sequencing. The EZ DNA 
methylation Gold kit (Zymo Research) will be used for sodium 
bisulfite conversion of DNA prior to library preparation for 
DNA methylation of select pain sensitivity SNPs for 40 
participants (5 zero and 15 highest pain phenotype per 
group).180 All libraries will be prepared using the TruSeq DNA 
Methylation (Illumina) method with 100 ng of converted gDNA 
per sample. Bisulfite-converted DNA will be first primed by 
random hexamers carrying a tag sequence on its 5′ end. 
Subsequently, the bottom strand DNA will be extended and 
the 3′ end annealed with another terminal-tagging oligo, which induces the synthesis of the 3′ adaptors. 
Single-stranded DNA fragments with adaptors ligated will be purified and enriched by traditional PCR 
according to respective kits’ instruction manuals. The resulting PCR products will be cleaned up and 
quality assessed by an Agilent 2100 Bioanalyzer. Before sequencing, the library will be spiked with 
other high-complexity sequences, according to the manufacturer’s protocol to compensate for the 
reduced sequence diversity in bisulfite converted libraries. Finally, amplified DNA fragments will be 
quantified by qPCR or PicoGreen assay and sequenced on NovaSeq 6000 platform to generate 
2 × 150 bp paired-end libraries. 
IFSMT Process Variables.
Knowledge and Beliefs.
The Self-Efficacy for Managing Chronic Illnesses Scale. The Self-Efficacy Scale181 is an NINR-
recommended common data element adapted to manage BF pain.
Breastfeeding Self-Efficacy Scale - Short Form. The BSES-SF scores > 50 indicating greater 
maternal BF confidence and demonstrates sensitivity to maternal experience with BF, with BF self-
efficacy at 1-week postpartum predicting BF methods at 4 and 8 weeks (p < 0.001).182  
Maternal Self-efficacy. Karitane Parenting Confidence Scale measures maternal self-efficacy with 
good test-retest discriminant reliability (r (26) = .88, p < 0.0001), .81 internal consistency, and sensitivity 
and positive predictive power are 86% and 88%, respectively.183 
Self-Regulation Skills and Abilities. 
Index of Self-Regulation. The Index of Self-Regulation is an NINR common data element used 
across several populations which assesses an individual’s general behavior and change effort to make 
behavioral changes and modulate thoughts, emotions, and behaviors to achieve goals.184,185
Breastfeeding Algorithm. An adaptation of the LATCH scale,163 through texted UConn Health 
REDCap link women will assess daily (BSM intervention) or weekly (attention control) infant 
awake/sleep state, signs of hunger, number of attempts to latch, strength of latch and of suck, pattern of 
pauses and sucks, and time duration of BF sessions. 
Maternal Assessment of Infant BF Behaviors. A clinical indicator of four infant BF behaviors 
based on the nursing personality assessment,162 maternal report, and digital recording of infant BF 
behaviors.156
Social facilitation.
Ongoing BF Assessment Survey. Maternal self-report of BF experience, adequacy of milk supply, 
problem-solving BF challenges (BNP), use of pharmacological and non-pharmacological therapies and 
social support. 
IFSMT Proximal Outcomes. 
Individual & Family Self-Management Behaviors. 
Table 3. Gene Minor Allele Frequency
SNP
Alleles
Frequency
COMT: Catechol-O-methyltransferase
rs6269
G>A
0.36 (Global)
rs4633 
C>T
0.37 (Global)
rs4818
G>C
0.30 (Global)
rs4680
A>G
0.37 (Global)
OXTR - oxytocin receptor
rs2254298
G>A
0.21 (Global)
rs53576
G>A
0.31 (Global)
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Acute BNP. A visual analogue scale (0 - 100) used to measure BNP intensity during the last BF.22 
Acute BNP will be measured with the short version of the Brief Pain Inventory.186,187 The Inventory has 
good reliability and validity with BNP.186,187 The Inventory has two subscales: pain intensity (4 items) 
and pain interference (7 items) and collects data on use of analgesics and of non-pharmacological 
measures.186 For initial data analysis, the average pain intensity and interference scores will be used, and 
other measures will be quantified. The McGill Pain Questionnaire short form is a reliable self-report 
measure of pain perception. It entails 15 verbal descriptors of sensory and affective dimensions of pain 
and is scored on a 4-point scale (0-none to 3-severe).188,189 Higher scores indicate higher levels of sensory 
and affective components of pain (range 0-45). Internal consistency reliability is in the excellent range for 
total pain score (Cronbach’s alpha = 0.96).
Cumulative BNP. A score of acute BNP pain intensity from the VAS (0 - 100) at baseline, 1, 2, 3, 6, 
9, 18, and 24 weeks will incrementally (baseline + 1 week, baseline + 1 and 2 weeks, etc.) be added 
together.
NINR PROMIS Scales for Maternal Well-Being Symptoms. The PROMIS scales of anxiety, 
perceived stress scale, sleep and fatigue. All PROMIS measures are based on the T-score (mean = 50, 
standard deviation = 10). In most cases 50 equals the mean in the U.S. general population.169–171
Edinburgh Postnatal Depression Scale. Postnatal clinical screening tool for depressive symptoms 
with any score >10 indicates risk for depression and scores > 13 a depressive illness that requires referral. 
Women will be referred to their provider for fourth trimester care and may continue in the study. The 
scale has a sensitivity of 85%, specificity of 77% to identify women at high-risk for depression.190  
H&H Lactation Survey. A 20-item questionnaire maternal perception of milk supply with a 7-point 
Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores ranged 20 ~ 140, with higher 
scores representing a higher perceived milk supply. The satiety subscale correlates with insufficient milk 
supply.191
IFSMT Distal Outcomes.
Health Status.
Exclusivity and Duration of BF measured by the Ongoing BF Assessment Survey and the BF 
algorithm. 
Quality of Life. 
PROMIS Global Health. Measures overall global physical health (function, pain and fatigue) and 
mental health (quality of life, satisfaction with social activities, and emotional well-being). (See above for 
scoring).169–171
Kaltura modules 
We provide voiced modules as part of our intervention. Please see attachments of breastfeeding 
intervention, postpartum care attention control, and infant development modules.
Describe opportunities provided to participants to ask questions in order for them to make an 
informed decision regarding participation.
 
Participant Recruitment will use active and passive methods successful in our pilot study with the 
addition of prenatal recruitment in the clinical sites. Passive methods include advertisements via 
Facebook pages and Instagram targeting women in Connecticut who intend to BF and flyers posted at 
Hartford Hospital, UConn Health, Connecticut Women, Infants, and Children prenatal clinics, and in the 
hospital common areas, given to women who express interest in BF during their prenatal care, and 
included in hospital discharge educational packets. Women who express interest in the prenatal period 
will be identified by a “sticky note” in Epic to facilitate recruitment in the postpartum period. Active 
methods include screening the inpatient unit census 3-7 times per week by our clinical partners for 
women who meet inclusion/exclusion criteria. Women who agree to speak with a member of the research 
team about the study will be approached in labor and delivery and in the postpartum unit. In order to ask 
initial screening questions via UConn Health REDCap, an evaluation of the participant’s capacity to 
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consent will be assessed and a HIPAA consent will be obtained. Women will be asked if they have any 
questions about the study before and screening, and before and after consent. If eligible, women will be 
consented in a private setting, by a member of the research team trained in obtaining informed 
consent.22,95,192  The consent process will be documented at Hartford Hospital and stored with the source 
documents. Participants will be identified in Epic at both Hartford Hospital and UConn Health to 
facilitate follow-up at 6 weeks and 6 months.
Evaluation of the study
At 6 weeks, women will be asked in a 10–15-minute audio taped semi-structured interview about their 
breastfeeding experience. At 6 months, women will be asked in a 10-15-minute audio taped semi-
structured interview to review their participation in and the impact of the study (see questionnaire).
Data Analysis and Management
All data will be entered into a password-protected database stored on a firewall-protected server that is 
maintained by UConn. We will use the existing structure of data management established with our pilot 
study. The protocols established for trialing and monitoring UConn Health REDCap will be strictly 
followed. We have designed data collection forms to check for missing data in real-time to avoid 
incomplete data and routinely monitor data input. Our Project Manager, working with the statisticians, 
will prepare a weekly data summary, which will be reviewed during weekly team meetings. 
Statistical Analysis Overview. Prior to undertaking statistical modeling, descriptive statistics will be 
determined for the study’s key independent and dependent variables in order to evaluate the effectiveness 
of randomization, to check distributional assumptions (such as normality), to identify potential outlying 
observations, and to obtain preliminary insights into homogeneity versus heterogeneity of variance for 
outcome measures. Analyses will be conducted using SAS 9.4193 and R194.
SA1. Initially, mixed effects linear modeling will be applied to contrast mean levels of pain at the 1-, 2-, 
and 3-week time points. The analyses will be repeated for a series of pain outcome measures, including 
BNP intensity, BNP interference, and cumulative BNP. The models will include “main” effects for 
intervention and time, an interaction between intervention and time, a random effect for “subject”, and the 
baseline value of the dependent variable as a covariate. Modeling results will be used to test for a time-
by-intervention interaction. If the interaction is non-significant, the model will be re-fitted without it and 
testing will focus on the main effect of intervention. Regression diagnostics will be applied to all models 
to identify non-normality in residuals and potentially biasing effects of outlying observations. While 
mixed effects linear models are resistant to the impact of limited amounts of missing data, we will also 
utilize multiple imputation methods, as described below, to evaluate the sensitivity of model estimates 
and testing results to missing observations. Following evaluation of intervention effects at the 1-, 2-, and 
3-week time points, we will proceed to assess differences in acute and cumulative BNP intensity and 
interference at 6, 9, 12, 18 and 24 weeks. Additionally, we will investigate whether subject-level “trends” 
or “growth curves” in pain levels across all eight study time points differ between the intervention and 
control conditions. If necessary, demographic variables will be included in the regression models both to 
account for potential confounding effects that might arise via imperfect randomization and to reduce 
unexplained between-subject variation in outcome variables.  
SA2. H2A. We will start by investigating the intervention's effect on proportion of exclusive BF after 
week 6. Initially, the Pearson Chi-square test will be performed to detect the difference between 
intervention and control groups at 6, 9, 12, 18, and 24 weeks, respectively. Furthermore, a generalized 
linear mixed model with a logistic link will be applied to analyze the “main effect” of intervention and 
time, and “interaction effect” of intervention by time. The procedure to fit and re-fit the model will be 
similar to the approach for pain measures in SA1. The measure for BF self-efficacy, yield scale scores 
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which range from 14-70. We will treat BF self-efficacy scores as “continuous” variable and follow the 
approach in SA1 to investigate the intervention effect on BF self-efficacy over time. H2B. Subsequently, 
we will assess intervention effects on maternal well-being - anxiety, depressive symptoms, fatigue, stress, 
and sleep disturbance over all the time points. Each of these variables' measurement scores will be treated 
as “continuous” and effects of the BSM intervention will be investigated following a similar approach as 
for the pain measures in SA1. Because these variables are highly interrelated, we will evaluate their 
response to intervention effects simultaneously. In this approach, differences in the quadrivariate means 
of these variables between the BSM and attention groups will be analyzed using multivariate mixed 
effects linear modeling in an approach analogous to that for the pain measures in SA1 but with the 
inclusion of covariances between random intercepts for the anxiety, depressive symptom, fatigue, and 
sleep disturbance scores at the subject level. Across the modeling procedures related to SA2, regression 
diagnostics will be applied to investigate suitability of distributional assumptions and potential biasing 
effects of outliers.  
SA3. We will model effects of pain sensitivity SNPs on quantitative sensory testing measures, BNP 
intensity and interference, BF outcomes in SA2, and maternal and pain self-efficacy across all the time 
points. In addition, we will also assess the effects of individual quantitative sensory testing measures on 
all the outcome measures aforementioned over time. Analyses will utilize “linear/generalized linear” 
modeling with univariate and multivariate dependent variables, will account for correct temporal ordering 
among time varying measures, and will evaluate correlations between measures that jointly vary in time 
in response to other factors/covariates. 
We have planned for attrition rates as high as 25%. However, our goal is to minimize attrition by 
instituting a participant outreach plan –namely, contacting participants to complete modules, providing 
monthly updates regarding child development, and encouraging women to remain involved. In statistical 
analyses, we will follow each model based only on “observed data” with sensitivity analyses in which 
Markov Chain Monte Carlo multiple imputation is used to assess the possibility and impact of “missing at 
random” data. 
Statistical analysis of methylation sequencing data.  Post-alignment analysis will be performed by 
using the MethPipe package (http://smithlabresearch.org/software/methpipe/). First, aligned sequences 
will be converted to MethPipe format using the to-mr command. Methylation levels and coverage for 
each symmetric CpG site will be calculated. Average CpG methylation levels of annotated genomic 
regions, i.e., promoters, exons, repeats, CpG islands/shores/shelves (CGI) will be calculated with the 
MethPipe roimethstat program. Only high-confidence genomic regions with at least 40 CpG observations 
from reads in the region will be retained for further analyses. Coordinates of promoters (-1000 bp and 
+100 bp from the transcription start site (TSS)), exons, introns and intergenic regions will be retrieved 
from Ensembl Regulatory Build (Ensembl release 101) and CGI annotations obtained from the UCSC 
Table Browser. Tissue-specific enhancer coordinates (+/- 1000 bp from peak) will be retrieved from the 
Human Encode Project38 (GRCh38/hg38). Hypermethylated regions and hypomethylated regions will be 
calculated by the hmr command from the MethPipe package. Unsupervised hierarchical clustering of 2 kb 
tile methylation will be performed using the R hclust command with the “ward” method. Correlation 
matrix will be calculated by the R corrplot package. Profile plot will be created by the R seqplots 
package. Gene ontology analysis will be performed by GREAT and DAVID Bioinformatics Resource 6.8. 
A Univariate ANOVA, followed by post-hoc Tukey HSD will be carried out to compare methylation 
within promoter region CGI for the six candidate genes (OXTR, COMT) identified in the preliminary 
studies. CGI methylation status of each gene will be assessed individually with control for multiple 
comparisons between conditions maintained, and post-hoc analysis with Tukey HSD will be adjusted to 
maintain an overall a = 0.05. 
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SA4. We will model effects of DNA methylation of OXTR and promoter regions of PRLR haplotypes for 
different single nucleotides polymorphisms (SNPs) on BNP and maternal perception of lactation 
insufficiency, BNP intensity and interference, and BF frequency across all the time points. Tumilara Amoo, 
will consult with the Institute for Systems Genomics to assist with statistical data analysis and interpretation 
of EPIC array raw data.
EPIC array raw data will be imported into the statistical analysis software Partek® Genomics Suite® for 
normalization, quality control, differential analysis and biological interpretations (gene ontology and/or 
pathway analysis). Statistical calculations (available within the software) will include Logistic 
Regression, Chi Square, False Discovery Rate, Fisher Exact, Power Analysis, and ANOVA. We propose 
to use the significance threshold of P<9x10-8 to control the false positive rate for EPIC array DNA 
methylation studies.
Inclusion/Exclusion Criteria:  
Inclusion Criteria 

female 

18 - 45 years of age

Patient at HH, WAHS, UConn Health

given birth < 48 hours to a singleton infant > 37 weeks gestational age 

having intention to BF

provided standardized BF basics during their antenatal care

with access to the internet via own smartphone, other device, or study-provided smartphone 
(provided at baseline and returned at 6-month research visit)

willing/able to consent to participate

having ability to read and write English as the intervention has not been tested in Spanish 
speaking population. 

assessed by a lactation consultant (CLC/IBCLC) during BF before discharge
Exclusion Criteria

<18 or ≥46 years of age

women with history of significant mental health disorder (e.g., major depression, schizophrenia, 
or bipolar disorder) due to additional challenges in the capacity for self-management

neurological or skin condition that inhibits, diminishes, or otherwise prevents sensation, such as 
eczema, rash, dermatographism on non-dominant forearm

delivery of an infant with medical complications or congenital anomalies

inability to communicate in English – although approximately 23% of the Connecticut population 
is Hispanic/Latinx (see page 25), women who speak/write in Spanish and other languages beside 
English will be excluded because our intervention has not been tested in Spanish. 
Post Enrollment Exclusion Criteria
Participants who are enrolled in the study may be withdrawn due to any of the following criteria:

non-compliance with study procedures such as failing to log daily entries and completing data 
collection points. At each data collection point, participants will be reminded via text to complete 
the surveys, with pushes from REDCap as needed to encourage completion. If needed, 
participants are followed up with a phone call or email to complete the surveys. If they do not 
complete the survey, they will be contacted for the next data point. If they do not complete three 
consecutive data points, they will be removed from the study, however any data collected will be 
used in analysis. 

Participants will be removed from the study at their own request.
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Potential Harms/Risks and Inconveniences: 
There is a potential risk of/for the following (protections or mitigating strategies for each are presented in 
the next section):
1)
Loss of confidentiality and privacy by participating in the study 
2)
irritation from the cutaneous mechanical and pressure sensitivity using the von Frey 
monofilaments, tuning fork, and Medoc pressure system. In our pilot study, women did not report 
adverse pain pressure from the von Frey monofilaments or the Medoc system. 
3)
Irritation of oral mucosa with collection of buccal cell swab sample. In our pilot study, women 
did not report any pain or irritation with buccal cell swab sample collection.
4)
Irritation, pain, infection, bruising at the site, and fainting associated with venipuncture. 
5)
Participant burden and inconvenience with the research team contacting the participant with bi-
weekly texting, providing educational videos, and weekly assessment measures
6)
Eye strain with prolonged period of time looking at the computer/text screen 
7)
Risks related to BF and infant health outcomes.
8)
Risks related to COVID-19 transmission.
9)
Risks to the research team against biohazards.
Protection against Risk
1) Protection against disclosure of participants’ privacy. To minimize the risk of accidental 
disclosure of participants’ private information and to maintain the confidentiality of their data, we will use 
the data management established during our pilot study and within the School of Nursing P20 Center for 
Accelerating Precision Pain Self-Management. Participant names will be masked by assigning each a 
unique participant identifier number (PID#) composed of random numbers (i.e., the code). All sources 
and written data will be stored in a secured, locked PI study-designated office in Mary Marshall Crim’s 
office at Hartford Hospital and Dr. Dana Scott’s office at UConn Health. No source or written data will be 
stored at UConn Storrs School of Nursing. No identifiable information on participants will be retained at 
other study sites and the key to the code will be retained at UConn Storrs. Audio files coded with subject 
ID, will be uploaded on the day of the interview to UConn Onedrive and then deleted from the audio 
recorder. UConn Onedrive  is HIPPA compliant with 2FA (2 factor authentication).  A study team 
member will open up a Microsoft 365 word document in One Drive. Microsoft 365 word version has a 
transcription feature under voice. A member of the research staff will upload the .wav file into the word 
document and select transcribe. The transcribe feature converts speech to a text transcript with each 
speaker individually separated. A member of the team will listen to the audio file to make corrections on 
the transcript and edit the transcript. The member of the research team will save the file on One drive for 
additional analysis. The audio files on Onedrive will be deleted after the transcription has been completed 
and the study has closed. Only members of the research team has access to the files. The analysis of the 
transcription will be conducted in a qualitative analysis program, Taguette. Taguette is a web based 
freeware that will be downloaded onto UConn or HH laptops and computers. Each deidentified transcript 
will be uploaded into the program. The team will tag sections of each interview that reflect an idea or 
theme. These coded interview sections will then be collected across interviews to clearly describe an idea. 
These quotes will be used to answer the questions we are asking. The key to the code will be destroyed at 
the time of study closure with the IRB, and de-identified data and samples will be kept indefinitely. 
Electronic data will be stored on firewall-protected servers with access via computers that are password-
protected and kept in locked buildings. Access to research data will be made available only to the 
investigators, and on an as needed basis to others on the research team. Information obtained as part of the 
study will remain confidential and not be disclosed to anyone (besides the participant) who is unaffiliated 
with UConn without consent from the participant, except as required by law or regulation. No information 
will be used in subsequent publications that would identify individual subjects. 
2) Protection against risk related to cutaneous pain testing equipment. There is a minimal risk 
associated with the quantitative sensory testing component of this protocol. Some women may not 
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tolerate the mechanical pressure of the quantitative sensory testing. The quantitative sensory testing 
mechanical pressure stimulator's controller is equipped with an emergency shut-down feature, which will 
be engaged if the stimulator's pressure is more than women can tolerate. The participant will always be 
free to move away from the stimulus or to stop testing at any time. The device and these types of stimuli 
have been widely used within our group and in groups around the world for many years with no adverse 
events.137,175 In our pilot study, all participants completed the sensory testing. In our pilot we found 
women how responded to mechanical stimulation was predictive of pain sensitivity. There is minimal risk 
associated with mechanical sensitivity measurement via punctate probes. The punctate filaments have a 
blunt tip that allows them to indent the skin without causing a puncture. Further, there is a finite amount 
of force that can be applied with any one filament. We will assess vibration detection via a tuning fork. 
This instrument has minimal to no chance of causing injury. The fork will be set to vibrate and the blunt 
base of the fork will be placed against the skin surface. 
3) Protection against risk related to buccal cell swab samples. There is minimal risk associated 
with buccal swab sample collection causing irritation of the mucosa. Women will be instructed to rinse 
their mouth with clean water to minimize bacterial contamination and decrease risk for irritation and 
infection from oral flora, before rolling the sterile buccal brush firmly on the inside of the cheek (10 
times). The likelihood that these problems will occur is low. 
4) Protection against risk related to venipuncture for blood samples. There is a minimal risk 
associated with blood draws which include irritation, pain, infection, bruising at the site, and fainting. 
Only experienced hospital or research staff will draw blood and no more than 2 attempts will be made to 
obtain blood.
5) Protection against risk of symptoms of maternal well-being distress. All participants will 
receive a pamphlet for the Hartford Hospital affiliated Institute of Living Peripartum Mood Disorder 
group, Postpartum Support International and suicide hotlines in their hospital discharge packet. Research 
team members at baseline will be trained to identify participants who exhibit emotional distress and will 
contact the PI for further questioning and consideration of referral to a mental health professional or 
social worker before hospital discharge if necessary. Secondly, the research team will check weekly for 
the Edinburgh Postnatal Depression Scale scores. A score >10 will trigger a texted script to the participant 
to ask how they are doing, inform them of their concerning score, ask them if they need a referral or 
follow up with their health care provider. If the participant is unresponsive to text, the PI will follow up 
with a phone call and immediate referral, if required. If the participant’s response includes thinking about 
suicide, it will trigger an immediate notification to Dr. Lucas, which includes reporting suicide risk to the 
health care provider (stated in the consent), assisting participant to immediate assessment at an urgent 
care or emergency department. In our pilot study, out of the 60 women one participant sought treatment 
for depressive symptoms. The pilot study found that all the women we contacted responded positively to 
the text and phone call follow-up and appreciated the support and referral for additional support. 
Likewise, this protocol surveillance addresses the needs of women during the fourth trimester and aligns 
with the CDC Hear Her campaign.  
6) Potential risk for participant burden and inconvenience. Based on our pilot study results, 
women reported the baseline data collection to be burdensome. We addressed this risk by removing 
several questionnaires to decrease participant burden and recruiting during the prenatal period. We 
anticipate by recruiting women during the prenatal period, women will be prepared for the time for 
participation and decrease the time burden. Women in the pilot study, reported that completing the paper 
BF diary 6 times a day was burdensome. For this project, we are using a text-based daily (one entry) BF 
diary. Women did not report the weekly measurements via UConn Health REDCap as burdensome and 
that the bi-weekly texting contact was supportive without burdening them to travel to face-to-face visits 
and places the mother-infant dyad at risk for illness, such as COVID-19. The initial data collection 
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appointment will take approximately 45-60 minutes. The daily breastfeeding log will take 5 minutes/1 
times a day for the first three weeks and from 15 days to 6 weeks a weekly breastfeeding log for 5 
minutes a day.  The scheduled data collection at Weeks 1, 2, 3, 9, 12, and 18 will take 30 mins to 
complete. The scheduled data collection for Weeks 6 and 24 will take 60 minutes. Additionally, 
participants may find logging daily feeding behaviors and multiple questionnaires an inconvenience. 
Receiving regular texts about their breast-feeding status may also be inconvenient. However, there is 
evidence to show that support via email and text during the first few weeks of delivery can be beneficial 
to breast feeding behaviors. 
7) Potential risk for eye strain with prolonged period of time looking at the computer/text 
screen. We will instruct participants to use a low light setting and the use of anti-glare software to reduce 
the strain. Participants will also receive reminders and daily surveys to complete, which may be 
inconvenient. The time commitment is explained in detail in the consent and will be verbally explained to 
each subject prior to signing the informed consent. Additionally, we will limit reminders to texts and text 
pushes via REDCap related to missing data and scheduling 6 week and 6-month research visits, with 
follow up phone calls as needed to encourage completion, or phone calls to address emergent clinical 
concerns to decrease the inconvenience to the participant. 
8) Protection of risks related to BF and infant health outcomes. Infants who BF or formula feed 
<6 times a day are at risk for dehydration and inadequate calorie intake. Women in the BSM intervention 
group will record daily number of feedings in their daily BF journal. Women in the attention control 
group will record the number of feedings per day once a week. A record of <6 feedings over a 24-hour 
period will trigger a notification email via UConn Health REDCap to the research team. The research 
nurse will contact the participant, evaluate the situation, and decide on the need for referral to a lactation 
specialist or their healthcare provider. This will also be done on a case-by-case basis. In our pilot study, 
no participants were referred for inadequate daily feedings. If the participant indicates they are having any 
difficulty such as mastitis or extreme pain, they will always be told to contact their PCP. Participants at 
every step of the research study will be encouraged to contact their provider if they are experiencing 
severe pain or discomfort such as fever.
9) Protection of risks related to COVID-19 transmission. Research team members will practice 
COVID-19 prevention measures at all points of face-to-face contact which include antenatal clinic, 
inpatient postpartum unit, follow-up data collection at 6 and 24 weeks at the Ambulatory Women’s 
Health Services clinic, Hartford Hospital Lactation clinic, the School of Nursing BBL at UConn Health or 
UConn Health Outpatient Obstetrics/Gynecology Clinic. These measures will minimize personal density, 
allow distances, wear personal protective equipment and follow best practice consistent with CDC 
guidelines, state guidelines, and applicable University and hospital policies. In addition, the study design 
delivers standardized and best practice BF and BNP problem-solving skills during an acute period of pain 
when the rate of BF cessation is the highest via mobile technology and when face-to-face visits are most 
burdensome and places the mother-infant dyad at risk for illness, such as COVID-19.
10) Protection of research team against biohazards. All research teams will complete Biohazard 
and Transportation of Biohazard training through UConn Environmental Safety Department. Collection, 
or Hartford Hospital Health Stream, storage and assays of biohazardous samples will be performed in 
accordance with established safety guidelines and regulatory requirements.
Benefits: 
Based on our pilot results, we anticipate that participants in the BSM intervention group will have 
decreased BNP intensity and interference and an increase in BF exclusivity. Women may experience 
satisfaction that future women may benefit through our enhanced understanding of how self-management 
strategies may decrease BNP, increase BF exclusivity and identify genetic factors that place women at 
risk for BNP. However, it is possible that women will not perceive any benefit to study participation. Due 
to the physical, emotional and financial toll of BF pain and the minimal potential risks of the proposed 
study, the potential benefits to future patients far outweigh potential risks. 
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Risk/Benefit Analysis:  
BNP is the leading reason 1 million women in the United States cease BF before 6 months, the optimal 
time for infant and women’s health. Although there may be no direct benefit to participating in the study, 
there are minimal risks to participating. Thus, the risk/benefit analysis is dependent on the knowledge to 
be gained from the study overall. In light of the high likelihood of identifying characteristics 
(demographic, psychological and/or genetic) of BF pain that influence self-management process and 
outcomes, findings will be highly relevant to practice, easily accessible and clinically sustainable 
allowing for large-scale translation in health care and public health settings. In addition to the focus of the 
research, it is possible that unexpected and/or unrelated information will be discovered that is not the 
focus of this study. This information will not be disclosed to the participant or to their insurance 
company.
Economic Considerations:  
There are no costs associated with study participation. Aligned with standard practices for increasing 
participant retention, we are using a scaled incentive plan. At enrollment, women will be informed they 
will be paid via a reloadable UConn Greenphire gift card or ecard (if they do not have a social security 
number) after each data collection point and if they participate at all data points, they will receive a study 
completion bonus. Participants will receive a $25 at baseline, 1, 2, and 3 weeks, $50 at 6 weeks, $35 at 9, 
12, and 18 weeks, and $75 at 24 weeks, and $25 as a completion bonus. They can potentially earn up to 
$355 if they complete the entire study. This amount was derived from estimating the time dedicated to 
completing the study protocol at each time point. 
Data Management:  
Source documents (biological, sensory, and questionnaire data) are created for all subject contact 
protocols and must be initialed and reviewed by the Project Manager and the research team with oversight 
by the PI once a week. All data will be entered into a password-protected database stored on a firewall-
protected server that is maintained by UConn. We will use the existing structure of data management 
established with our pilot study. The protocols established for trialing and monitoring UConn Health 
REDCap will be strictly followed. We have designed data collection forms to check for missing data in 
real-time to avoid incomplete data and routinely monitor data input. Our Project Manager will assist with 
downloading and updating the database, which will be reviewed during weekly team meetings. 
Audio files coded with subject ID, will be stored on UConn Onedrive. Only members of the research 
team has access to the files. Analysis and coding of the audio files will be conducted on UConn or HH 
laptops and computers.
Data Safety Monitoring:  
We will have several mechanisms ongoing throughout the study as part of the Data Safety and Monitoring 
Plan and to monitor the potential occurrence of adverse events (AEs). First, the PI and the study staff 
(Drs. Lucas and Project Manager) will oversee the day-to-day monitoring of all study activities. All data 
will be stored in locked cabinets within locked offices in the School of Nursing and password-protected 
computers. Electronic data will be encrypted for storage and de-identified for all study analyses. Data 
checks, for congruence and missing values, will occur weekly with double-checking (by two research 
study staff) to ensure accuracy. 
Second, participants will be provided with day and after hours contact information for the PI and the 
study staff, and they will be instructed to report any, and all concerns related to study participation to the 
PI and/or the study staff. In addition, the PI will have weekly meetings with study staff to discuss study 
progress (recruitment, data collection and retention), any AEs that occur, and any issues that may arise 
during the study. Any adverse event that occurs will be directly reported by the PI to the IRB and 
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sponsoring agency within 24 hours of occurrence. Communication will occur through direct phone calls 
and follow-up email.
Data Safety and Monitoring Board
The PI will recruit three experts who are not involved with this research study to serve on an independent 
review committee. Members of the board will be experts in nutrition and BF, self-management related to 
pain, and genomic statistical methods. The Data Safety and Monitoring Board will review the study 
protocol prior to activation and develop a Data Safety and Monitoring Board plan. The Data Safety and 
Monitoring Board will evaluate the data on an ongoing basis and assure participant safety and study 
integrity. The Data Safety and Monitoring Board will be responsible for monitoring data and for making 
recommendations based on the data regarding appropriate protocol and any operational changes. The 
review committee will meet every 3 months to review progress, preliminary data, and any adverse events. 
They will meet with the PI and CoIs to make recommendations regarding the progress of the study and 
will be able to report to the Institutional Review Board of the University of Connecticut. Following 
review, the Data Safety and Monitoring Board will write a report outlining recommendations. These 
recommendations will be forwarded to the PI and the Institutional Review Board Chair at the University 
of Connecticut.
Privacy/Confidentiality Part 1
To minimize the risk of accidental disclosure and maintain confidentiality of participants’ confidential 
information and data, each participant will be assigned a unique participant identifier number (PID#). The 
PID is composed of random numbers, not names, and will be stored separately from the consent form in a 
locked research area. All participants will be screened using a SID number. The PID data from 
participants who failed screening will be used to describe and analyze the sample population. Any paper 
questionnaires will be kept in a locked file cabinet for 6 years in Mary Marshall-Crim’s office at Hartford 
Hospital and Dr. Dana Scott’s at UConn Health office until the study ends and will be destroyed at that 
time. Identifiable key-codes to the data will be retained at UConn Storrs until the completion of all study 
procedures including all analysis of samples.  This is necessary to allow for efficient co-ordination of 
subject recruitment, and to contact participants for follow-up visits. Buccal cell and/or blood samples will 
be labeled with ID numbers and stored in a secured research laboratory until it is processed and retained 
for batch processing. Buccal samples will be stored in the School of Nursing Biobehavioral Lab and be 
transported to a UConn lab service center or shipped for batch processing at Dr. Young’s Laboratory at 
University of Kansas Medical Center or a UConn lab service center. Genetic samples will be retained for 
the duration of the study.  De-identified biological samples and de-identified data will be made available 
to all study staff on the IRB protocol for analysis. The key to the subject IDs will only be made available 
to Dr. Lucas and Project Manager. 
All source and written data will be stored in a secured, locked study-designated office in Mary Marshall-
Crim’s office at Hartford Hospital and Dr. Dana Scott’s office at UConn Health. No source or written 
data will be stored at UConn School of Nursing. Electronic data will be collected and stored on UConn 
Health REDCap and firewall-protected servers with access via computers that are password-protected and 
kept in locked buildings. Access to research data will be made available only to the PI and on an as 
needed basis to other study staff. Information obtained as part of the study will remain confidential and 
not be disclosed to anyone unaffiliated with UConn without consent from the participant, except as 
required by law or regulation. No information will be used in subsequent publications that would identify 
individual subjects. 
Once study analyses of the samples have been complete, all de-identified data will be retained 
indefinitely. Participants will have the option of leaving their contact information to be part of future 
studies. If they consent to that, we will keep a listing of the contact information in a pool for future studies 
in a secure encrypted file or in a secure locked cabinet until the remainder of the study.
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Informed Consent
Consent/permission Setting:  
All eligible individuals will meet with a trained research team member and will be asked to read 
and sign the study consent form prior to enrollment. The consent form addresses the following 
issues; 1) the purpose of the study, which is to examine the feasibility of the BSM intervention, 2) 
each of the measurements that will be made in the study will be discussed, 3) the ability of the 
participant to obtain and continue to receive medical care will not be affected adversely if they 
choose not to participate in the study, 4) each participant will be responsible, along with their 
insurance carrier, for clinical care costs, and 5) if at any time the participant feels that they do not 
wish to continue to participate in the research study during data collection they can discontinue 
their participation.
Informed consent will be obtained in a private area at Hartford Hospital or UConn Health Center with a 
research team member trained in providing informed consent. They will have as much time as needed to 
make a decision. The research team members will give them a consent form to review and return at a time 
that is convenient for them if they decide to participate before, they are discharged home. Privacy will be 
maintained by ensuring a private setting for the consent process. Potential participants (or their 
accompanying legal guardian) will be asked to read through the consent form and will be given adequate 
time to read and ask questions. Using the script, the research team number will ask the participants basic 
questions about the research (purpose, procedures, risks, voluntary nature) and ask if the participants have 
any questions about the research. If the potential participant is interested in the study, they will be asked 
to sign the consent form.
Capacity to Consent: 
Eligible participants will have full decision-making capacity and ability to read and speak English. 
The research team will document the capacity to consent for each participant which will be kept 
with the participant’s consent. Exclusion criteria for the study include individuals with known 
psychiatric diagnosis of bipolar disorder or schizophrenia. Research assistants, graduate assistants, 
and peer counselors at Hartford Hospital are Latina, Black, and Caucasian, which will facilitate 
recruiting and collecting data for the 23% of women in Connecticut who are Hispanic and with 
this collaboration we anticipate planning future studies to target Spanish speakers after the 
Spanish version of the intervention has been tested. 
Waiver or Alteration of Consent:  
We are requesting waiver of signed consent for conducting the screening form prior to recruiting 
participants in the study. The initial screen will collect information about demographics and medical 
history as well as contact information, which are essential to determine if the participants will fit into the 
inclusion criteria of the study and allow for more efficient recruitment. The research presents no more 
than the minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of research context.
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The participants will be asked to provide HIPPA consent at the beginning of the preliminary 
screen that all information they give is voluntary and skip any question they are not comfortable in 
answering. They will be told that we will take all necessary steps to protect their privacy, but it 
cannot be 100% guaranteed. The HIPPA consent will be filed with the participant’s consent file.
We will take all necessary measures to ensure confidentiality is protected. The risks will be 
minimized by taking the following measures: The capacity to consent, HIPPA consent and study 
consent will be stored in locked cabinets in Mary Marshall-Crim’s office at Hartford Hospital and 
Dr. Dana Scott’s office at UConn Health. The screening and patient response to surveys will be 
stored in UConn Health REDCap encrypted platform.  The screening will be conducted on a 
confidential phone line in a private room or in a private setting in the hospital suite. The 
enrollment log will be stored in an encrypted file on a shared document via UConn Storrs 
OneDrive.
We are requesting the waiver only for the initial screen process, an informed consent process 
would take place once the participant consents to participate in the study.
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