Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
Phase: NA
Conditions: Breast Feeding
Sponsor: OhioHealth

Study Title: Happy, Healthy, Loved: A Mobile-delivered Breastfeeding 
Self-efficacy Intervention for First Time Parents 
NCT Number: NCT04578925 
Document Date: 10/05/2020 

HAPPY, HEALTHY, LOVED
Principal Investigator: Marie Cooper, RNC-LRN, BSN, MBA 
  Riverside Methodist Hospital
  Director of Women’s Health Services 
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TABLE OF CONTENTS
1.0
Introduction
1.1
Background
1.2
Theoretical Framework 
1.3 
Specific Aims/Rationale
2.0
Methods
2.1
Study Population
2.2
Study Variables & Outcomes of Interest
2.3
Study Design
2.4
Statistical Analysis
3.0
References
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I.
INTRODUCTION
Breastfeeding’s health benefits are extensive and well established. For infants, health 
risks such as sudden infant death syndrome, infections, diabetes, obesity, and asthma(Sung et 
al., 2016) are lower; for mothers, breastfeeding is associated with lower risks of breast and 
ovarian  cancers(Zhou  et  al.,  2015). Major  health  organizations  recommend  exclusive 
breastfeeding for at least the first six months postpartum (Eidelman, 2012). However, exclusive 
breastfeeding in the US is reported by only 44.4% of women at three months postpartum  (CDC) 
and even lower in Ohio where this study is proposed (CDC). Improving exclusive breastfeeding 
rates is among the nation’s health priorities outlined in Healthy People 2020 (CDC). We propose 
a  randomized  trial  of  an  affordable,  scalable  intervention  to  improve  rates  of  exclusive 
breastfeeding, an important national health priority.  
Theoretical Underpinnings: Targeting Breast Feeding Self-Efficacy, Partner Support and 
Coping. Bandura’s self-efficacy, originating in social cognitive theory, is defined as confidence in 
one’s  ability  to effectively  perform  a  specific  task  or  reach  a  goal  (Bandura,  1977).  The 
framework of breastfeeding self-efficacy (BSE) posits that confidence in the ability to breastfeed 
predicts breastfeeding effort and ability to persevere through common challenges such as 
latching difficulties, perceived supply concerns, and return to work (Dennis, 1999; McCarter-
Spaulding & Dennis, 2010). Four sources of information are central to the development of BSE: 
performance accomplishments in breastfeeding, exposure to other women’s breastfeeding 
experience, encouragement from influential others, and physiological responses to stress and 
anxiety (Dennis, 1999). 
Multiple  studies  have  established  a  link  between  BSE  and  duration  of  exclusive 
breastfeeding,  including  our  own  research,  which  suggests  BSE  at  two  days  postpartum 
significantly predicts exclusive breastfeeding rates at 6 months postpartum among primiparous 
mothers (Henshaw, Fried, Siskind, Newhouse, & Cooper, 2015). Similar findings are reported 
with outcomes at 4 months postpartum in an Australian sample (Baghurst et al., 2007) and 6 
months postpartum in a Canadian sample (Semenic, Loiselle, & Gottlieb, 2008). 
A limited number of randomized controlled trials to improve BSE have been conducted, 
with  promising  results.  A  recent  systematic  review  and  meta-analysis  found  that  BSE 
interventions  effectively  improve  exclusive  breastfeeding  duration (Brockway,  Benzies,  & 
Hayden, 2017).The majority of interventions are delivered in one-on-one interventions with 
between 1-3 contact points (Brockway et al., 2017). Authors of recent BSE interventions suggest 
that continued contact and engagement with women during the first months postpartum may 
enhance the impact of BSE interventions (McQueen, Dennis, Stremler, & Norman, 2011; Otsuka 
et al., 2014). Mobile phone text message delivery, which has been found to be efficacious in 
altering  other  health  behaviors (Hall,  Cole-Lewis,  &  Bernhardt,  2015),  is  a  cost-effective 
direction for future BSE interventions. If efficacious, mobile programs can be translated and 
culturally adapted for women with diverse backgrounds. However, to our knowledge no current 
BSE programs combine text-message delivery and partner involvement.
Partner support. Among partnered women1, partners are uniquely positioned to be 
1 Our proposed study is inclusive of same-sex parent couples; however, most existing literature has studied fathers exclusively. 
The term father is used when referencing work conducted with fathers; partner is used when referencing our own study design. 
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sources of support and influential in developing BSE during the postpartum period, yet few 
breastfeeding programs have attempted to involve partners directly. Developing programs 
involving  partners  is  a  recommended  action  in  the  Surgeon  General’s  2011  report  on 
breastfeeding, due to the important influential role of the partner  (McGuire, 2011). Fathers’ 
support of breastfeeding is associated with higher rates of breastfeeding initiation, duration, 
and exclusivity  (Kessler, Gielen, Diener-West, & Paige, 1995; Maycock et al., 2013). Research 
suggests that fathers feel willing but unprepared to support breastfeeding  (Brown & Davies, 
2014), suggesting a need for interventions directly equipping them for this role.  
Few randomized trials have included partners in breastfeeding education, and even 
fewer have utilized technology in targeting partners; however, among published intervention 
trials, promising results have been found when engaging fathers. Prenatal education of fathers 
in a previous trials resulted in higher rates of breastfeeding initiated and sustained at six weeks 
when compared with control conditions (Maycock et al., 2013; Wolfberg et al., 2004).  Most 
recently,  a  randomized  controlled  trial  providing  breastfeeding  support  to  couples  found 
significant differences in overall breastfeeding rates at 3 months postpartum, but not exclusive 
breastfeeding(Abbass-Dick, Stern, Nelson, Watson, & Dennis, 2015; Abbass-Dick et al., 2017). 
Two recent internet-based interventions involving fathers have been introduced; a website 
breastfeeding  resource  targeting  fathers  and  partners  in  education  and  a  “gamified” 
breastfeeding support mobile app exclusively for fathers (Abbass-Dick et al., 2017; White et al., 
2016). Both have been described in the literature but published randomized trial outcomes are 
not yet available. To our knowledge, neither technology-based programs nor in-person sessions 
for fathers have incorporated information for partners that is tailored to the specific challenges, 
strengths, and support preferences of the couple. 
Positive coping. The relationship of negative emotional states or stress and breastfeeding 
has been well established; for example, results of a systematic review suggest early postpartum 
depressive symptoms are associated with lower BSE and lower breastfeeding duration (Dennis 
& McQueen, 2009), and recent prospective analysis found 3 month anxiety symptoms predicted 
reduced odds of exclusive breastfeeding at 6 months(Adedinsewo et al., 2014). Neuroendocrine 
activity associated with reported stress and anxiety may interfere with production and letdown 
of milk(Stuebe, Grewen, Pedersen, Propper, & Meltzer-Brody, 2012), while cognitive patterns 
such  as  rigid  expectations  and  focus  on  self-deficiencies  may  result  in  less  rewarding 
breastfeeding experiences, ultimately contributing to avoidance and discontinuation(Dennis, 
1999). 
Positive management of stress and physiological arousal is a key component of BSE 
theory and therefore is a main behavioral target in the proposed intervention. Aligned with 
theoretical mechanisms of change in BSE theory, the goals include engaging in constructive 
internal dialogue and managing emotional reactions to challenges along with enhanced ability 
to produce calm, relaxed physiological states (Dennis, 1999). Cognitive-behavioral theory is the 
basis of several efficacious programs to produce positive coping for the prevention of stress and 
negative emotional states (Barrera, Wickham, & Munoz, 2015; Le, Perry, & Stuart, 2011). Core 
components  include  cognitive  strategies  to  foster  flexible,  self-compassionate,  realistic 
interpretation of one’s self and environment, coupled with behavioral strategies to increase 
rewarding or meaningful activities, increase support networks, and challenge negative self-
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beliefs (Beck, 2016).  Previous randomized controlled trials suggest that cognitive behavioral 
coping skills can be effectively taught via internet delivery (Barrera et al., 2015; Milgrom et al., 
2016; O'Mahen et al., 2013). 
Improving breast-feeding with a mobile intervention program. The proposed study will 
test if the program  Happy, Healthy, Loved (HHL) can be effectively delivered using a mobile 
intervention program that includes partner support and actively addressing stress management. 
Our mobile program is a two-part delivery process that begins with a brief interactive tablet 
program in the hospital during the postpartum stay. The tablet portion is designed for parents 
to complete together, and it includes questions for mothers and partners about motivations for 
breastfeeding, challenges experienced, preferred methods of coping with stress, and preferred 
support gestures from the partner. This information is then used to provide brief tailored text-
message prompts to mothers and partners during the first 6 weeks postpartum, with follow up 
outcome  at  6  weeks  and  6  months postpartum. Internet based interventions  have  been 
demonstrated to be efficacious in influencing a wide range of health behaviors (Wantland, 
Portillo, Holzemer, Slaughter, & McGhee, 2004). 
Offering HHL as an in-hospital program followed by small, continuous-dosage mobile-
based materials that do not require a large block of time for reading or exercises can reduce 
patient burden and increase engagement. Mobile-based HHL addresses partners directly to 
improve support behavior, but tandem text-message delivery, unlike in-person or telephone 
delivery, ensures that dual-parent scheduling is not a barrier to treatment. Preliminary pilot 
data suggests that the content and method of delivery are both highly acceptable to mothers 
and partners, and preliminary pilot data suggest positive outcome trends when mother and 
partner both receive the mobile intervention. 
The intervention emphasizes three behavioral targets: a) providing resources to support 
breastfeeding through modeling, information, and feedback (tailored to maternal reported 
breastfeeding challenges and motivations); b) providing prompts to mother and partner to 
communicate about support strategies (tailored to parents’ preferred support behaviors); and c) 
providing prompts for positive evidence-based coping strategies (tailored to parents’ preferred 
coping activities). Exclusive breastfeeding as well as breastfeeding self-efficacy will be measured 
at 6 weeks and 6 months as primary outcomes. Secondary outcomes of coping behaviors and 
perceived partner support are the behavioral targets that are hypothesized to influence the 
primary outcomes of BSE and exclusive breast feeding and will also be measured at 6 weeks and 
6 months. Because the intervention emphasizes coping strategies for managing stress, we 
hypothesize that baseline cortisol will act as a moderator for the intervention, with mothers 
experiencing elevated cortisol benefitting the most from the intervention.
In 2017, we conducted a small pilot study to test the feasibility of our HHL program. We 
enrolled 17 mothers and 10 partners to complete the baseline assessments and then randomly 
assigned them to the HHL group (n=8 mothers) or usual care (n= 8 mothers). Follow-up rates at 
6-weeks postpartum were 94% for mothers and 90% for partners. Mothers and partners who 
completed the HHL intervention (n=12) rated the acceptability of the program on a five-point 
agreement scale. The majority of parents agreed or strongly agreed that the program was 
beneficial (83%) and that participating was manageable (91.7%). No parents opted to stop 
receiving messages during the six-week delivery. 
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Investigating individual variability in intervention effectiveness. In the final aim of the 
proposal, we explore the extent by which subjective reports of stress and a biological indicator, 
namely hair cortisol levels, at baseline, and post intervention is associated with the mechanisms 
of change, as well as breast feeding rates. We hypothesized that higher levels of cortisol will be 
associated with lower levels of baseline positive coping, BSE, and partner support. Importantly, 
we also explore both self-reported stress, and hair cortisol levels as moderators of the effects of 
the intervention. The effects of any behavioral intervention vary significantly, and precision 
medicine approaches advocate that prevention and treatment strategies take seriously this 
variability (Insel, 2014). While the majority of this approach has been applicable in the context 
of oncology, it has important implications for psychological and behavioral research. Consistent 
with past studies, suggesting that interventions may be particularly useful for those with higher 
vulnerability at baseline(Blow et al., 2009; Snider et al., 2018), we hypothesized that the 
intervention would have the biggest impact on mothers with the highest levels of perceived 
stress and cortisol levels.
We look specifically at subjective reports of stress and hair cortisol due to a large body of 
research demonstrating intriguing relations between neuroendocrine mechanisms and failed 
lactation, as well as perinatal mood disorders (Stuebe et al., 2012).  Elevated cortisol in the 
perinatal period is associated with the development of mood disorders (Magiakou et al., 1996; 
Nierop, Bratsikas, Zimmermann, & Ehlert, 2006a; Nierop, Bratsikas, Zimmermann, & Ehlert, 
2006b). In addition, stress is associated with non-responsive feeding styles (Hurley, Black, Papas, 
& Caulfield, 2008) and undesired weaning (Sjolin, Hofvander, & Hillervik, 1977). Causal evidence 
demonstrating that chronic stress exposure leads to deficits in maternal care and increases in 
anxiety and impaired lactation were found in rodent models (Murgatroyd et al., 2015).
Traditional  methods  of  assessing  cortisol  levels  via  saliva,  urine  or  plasma  are 
cumbersome, requiring multiple assessments in order to ascertain long term exposure, thus 
increasing participant burden, attrition and limiting its application during the post-partum 
period. Hair cortisol provides longer retrospective calendar of exposure to stress, thus has the 
potential to be a non-invasive biological variable that can be collected with ease, making it an 
excellent candidate for assessing chronic stress in new mothers. Hair cortisol level is associated 
with traditional salivary cortisol levels throughout pregnancy (D'Anna-Hernandez, Ross, Natvig, 
& Laudenslager, 2011; Kirschbaum, Tietze, Skoluda, & Dettenborn, 2009a), and is related to self-
report levels of stress among pregnant women (Kalra, Einarson, Karaskov, Van Uum, & Koren, 
2007). At the same time, a significant body of research demonstrates that self-reports of stress 
do not always correlate with biological indicators such as cortisol(Kalra et al., 2007; McLennan, 
Ihle, Steudte-Schmiedgen, Kirschbaum, & Kliegel, 2016; Milam, Slaughter, Verma, & McConnell, 
2014), thus begging the question of which measure may be best for assessing stress in new 
mothers. By using both self-report measures of stress, as well as hair cortisol as a biological 
marker, we are able to examine their relations to one another as well as their role in moderating 
the effects of the intervention. Thus, findings from the current study has the ability to both 
provide further evidence for hair cortisol as a biomarker of exposure to stressful life events 
during the prenatal period, as well as its feasibility in predicting the efficacy of interventions. 
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II.
METHODS
A. Study Population 
Primiparous, breastfeeding women living with a partner will be recruited directly on the 
maternity floors of three OhioHealth hospitals, Riverside Methodist Hospital (RMH), Grant 
Medical Center (GMC), and Doctors Hospital. Based on our pilot data, we plan to enroll up to 
200  mother-partner  pairs  over  a  24-month  period.  Based  on  Cohen’s  standard  power 
functions, 80% power to detect a medium-large effect in outcomes (alpha = .05) should be 
achieved with 64 participants per arm, leading to the proposed plan of a minimum of 60 
couples per arm (Cohen, 1992). Assuming a conservative 25% attrition rate to achieve a final 
number  of  128  couples,  as  well  as  the  possibility  that  one  member  of  a  couple  ends 
participation while the other continues, we estimate needing to enroll between 160-200 
couples. Therefore, we will enroll up to 200 mother-partner pairs during the study period of 
September 1, 2020 and September 1, 2022.  
1. Inclusion criteria includes primiparous mothers:
a. over the age of 18 years old,
b. living with a partner or spouse
c.
have  an  intention  to  breastfeed  their  infant  for  at  least  6-weeks 
postpartum;
d. whose infant is not in the Neonatal Intensive Care Unit, 
e. have a mobile phone with text message capability,
f.
have no current self-reported depressive episode, and;
g. English as a primary language
2. Exclusion criteria include mothers who:
a. have other biological children (past breast-feeding experience), 
b. have infants in the Neonatal Intensive Care Unit, 
c.
do not have a mobile phone with text message capabilities, 
d. report current episodes of depression, or are receiving antidepressant 
treatment or psychotherapy for depression,
e. have initial study survey that indicates suicide risks (participants who are 
identified as suicidal ideation at 6 weeks or 6 months will receive further 
assessment and referral but not be excluded from the program because it 
may be more harmful and penalizing to remove them from the program if 
they find it helpful. We will remind the participant that continuing is 
voluntary  and  there  is  no  penalty  if  they  wish  to  discontinue 
participation)
f.
do not speak, read and write English
B. Aims and Hypotheses:
Aim  1: Investigate  the  efficacy of  mobile-delivered breastfeeding self-efficacy  program  on 
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breastfeeding rates and breastfeeding self-efficacy, as compared to care as usual. 
Hypothesis  1:  Participants  randomly  assigned  to  the  intervention  will  report  higher 
breastfeeding self-efficacy and exclusive breastfeeding at six weeks and six months postpartum 
compared to those assigned to usual care.
Aim 2: Assess whether improved coping with stress (as measured by self-reports), and partner 
support (as measured by partner and self-report) are mechanisms for the intervention. 
Hypothesis 2: Participants randomly assigned to the intervention will report increased positive 
coping behaviors and higher perceived partner support at six weeks and six months postpartum 
compared to participants assigned to usual care.
Aim  3:  Investigate  relationships  among  levels  of  hair  cortisol,  stress  (e.g.  as  indexed  by 
subjective reports of stress) and resilience (social support and positive coping) factors. 
Hypothesis  3:  Hair  cortisol  levels  measured  immediately  postpartum  will  be  positively 
associated with symptoms of depression, anxiety, and stress, and negatively associated with 
perceived partner support and effective coping.
Aim 4: Investigate hair cortisol levels as a biological indicator of susceptibility (e.g. moderator) 
to intervention effects.
Hypothesis 4: Mothers who have moderate-high hair cortisol levels will benefit most from HHL.
C. Study Variables 
A summary of the measures proposed is provided in the table below. 
Construct
Measure
0-2 days 
postpartum
6 weeks 
postpartum
6 months 
postpartum
mom
partner
mom
 partner
mom
partner
Breastfeeding
Index of breastfeeding status
x
x
x
Self-efficacy
Breastfeeding self-efficacy scale 
short form
x
x
x
x
x
x
Coping Behavior
brief COPE
x
x
x
x
x
x
Partner Support
Postpartum Partner Support 
Scale
x
x
x
x
x
x
Social provisions checklist
x
x
x
x
x
x
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Mood/Stress
Edinburgh Postnatal Depression 
Scale
x
x
x
x
x
x
Depression, Anxiety, and Stress 
Scale
x
x
x
x
x
x
Maternal Mood Screener 
x
x
x
x
x
x
Sleep Quality 
(cortisol 
covariate)
Pittsburgh Sleep Quality Index
x
Acceptability & 
Adherence
HHL acceptability scale
Participant adherence  
x
x
x
x
Demographics
Demographics and cortisol 
covariates. Demographic 
information includes: Ethnic and 
racial identity (self-report), Study 
role, Relationship status, Income, 
Education, Age, Gender, Sexual 
preference, Primary Language, 
Number of persons in household 
(not counting new infant), 
Relationship to people living in 
the household, Employment, 
Plans to return to work, Timing 
of planned return to work, Email 
address, Phone number, Cell 
phone type, Cell phone use, 
Frequency of text messages, 
Opinion on importance of cell 
phone, Presence of a pregnancy 
or parenting app on the cell 
phone and type, medical record 
number
x
x
Delivery info
Infant weight and Apgar score, 
delivery method, maternal 
weight & height in 
pregnancy/delivery. 
Collected from records and 
entered in REDCap by the 
research coordinator
Cortisol2
Hair habits interview
x
Maternal hair sample 
Collected by research 
coordinator
x
2 Only for mother’s with at least 3 cm of hair who opt to participate in this portion of the study
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1. Measures
The following validated outcomes and proposed mechanism measures will be used at 
one or more of the three data collection time points: pre-intervention and six weeks as well as 
six months postpartum. The schedule of measures administered at each timepoint is indicated 
in the data collection schedule table above. The survey will be administered through an online 
link using an ID code to identify participants in the REDcap survey. The follow up survey will be 
administered through a REDCap link sent via email with text-message reminders. The six week 
follow up survey is designed to measure  immediate outcomes following the intervention 
content. The six-month follow up is designed to measure whether the six week intervention 
produces lasting differences in proposed outcomes. 
Demographics and cortisol covariates. In addition, we will also assess at baseline basic 
demographics and established covariates of hair cortisol levels. These will include relationship 
status, birth method (vaginal or caesarean), body mass index, maternal education level, hair 
characteristics, and number of individuals in the household (Dettenborn, Tietze, Bruckner, & 
Kirschbaum, 2010) 
Edinburgh Postnatal Depression Scale (Cox, Holden, & Sagovsky, 1987). The EPDS is a 
well-validated 10-item self-report depression screening tool, in which endorsement of each 
item is based on how women feel during the previous 7 days. Possible scores range from 0 to 
30, with high scores reflecting more depressive symptoms. The EPDS has shown high sensitivity, 
specificity, and positive predictive power for postpartum depression when using the 10+ score 
cutoff (Dennis & Ross, 2006; Zelkowitz & Milet, 1995). Across a variety of studies with women, 
consistency has been at acceptable levels (Cronbach’s alpha .73--.87, test-retest .53--.74; (Boyd, 
Le, & Somberg, 2005). The EPDS has also been validated as an acceptable screening tool for 
men in the postpartum period (Edmondson, Psychogiou, Vlachos, Netsi, & Ramchandani, 2010; 
Matthey, Barnett, Kavanagh, & Howie, 2001). 
Maternal Mood Screener (Munoz, 1998). The mood screener questions were adapted 
from the Diagnostic Interview Schedule (Robins, Helzer, Croughan, & Ratcliff, 1981) and assesses 
lifetime and current major depressive episode. Positive endorsement of 5 out of 9 depression 
symptoms present for at least two weeks screens positive for  possible  major  depressive 
episode. The screener is a self-report checklist using DSM-IV criteria that has shown high (kappa 
= .76) concordance with the SCID-CV, the gold standard diagnostic interview for depression 
(Vázquez, Muñoz, Blanco, & López, 2008). The assessment for lifetime and current major 
depressive episodes will be administered at 0-2 days post-partum and only the assessment for 
current episodes will be administered at the 6 week and 6 month follow-up time points. 
Depression Anxiety and Stress Scales (DASS-21). The DASS-21 will be used to measure 
the unique symptoms of each state. There is normative data for the scale, and the depression 
and anxiety subscales have shown high convergent validity with the Beck Depression Inventory 
and Beck Anxiety Inventory (Antony, Bieling, Cox, Enns, & Swinson, 1998). 
Index  of  Breastfeeding  Status.  Rather  than  conceptualizing  breastfeeding  as  a 
dichotomous outcome, participants’ level of breastfeeding exclusivity will be measured as a 
continuous  variable  differentiating  among  exclusive,  partial,  and  token  breastfeeding  as 
suggested by previous authors (Labbok & Coffin, 1997)  Women will be asked to identify the 
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level that accurately described their breastfeeding behaviors within the previous 24 hours.  Four 
levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast 
milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby 
not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding. 
This measure has been successfully used at RMH in previous research (Henshaw et al, 2015).  
Breastfeeding Self-Efficacy Scale-Short Form (McCarter-Spaulding & Dennis, 2010). The 
BSES-SF has demonstrated strong reliability and validity and will be used to measure BSE. Higher 
scores indicate greater self-efficacy related to breastfeeding.  High internal consistency has been 
demonstrated in previous samples (Cronbach’s α=.91; (Henshaw et al., 2015). A wording change 
to  measure  self-efficacy  in  the  supportive  partner  role  has  also  been  validated  (Dennis, 
Brennenstuhl, & Abbass-Dick, 2018)  and will be used for the partner survey.
Brief COPE. This 28-item validated scale derived from a previously published measure 
showing reliability (Cronbach’s α=..62--.85, test-retest r = .46--.89) and convergent validity with 
several established coping measures  (Carver,  Scheier, & Weintraub, 1989) will be used to 
identify coping strategies consistent with cognitive-behavioral skills, such as positive reframing, 
and absence of avoidance (Carver, 1997). 
Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality, which is a critically 
important covariate of hair cortisol and mood. The PSQI is well-established questionnaire for 
assessing sleep quality, duration and disturbances. The PSQI shows good internal consistency 
Cronbach’s  α=.83, test-retest reliability (r  =  .85) and predicted clinically determined poor 
sleepers at sensitivity of 89.6% and specificity of 86.5% (Buysse, Reynolds, Monk, Berman & 
Kupfer, 1989). The PSQI reliability and validity has been established with a pregnant sample as 
well (Skouteris, Wertheim, Germano, Paxton & Milgrom 2009). Unlike the other outcome 
measures, the Pittsburgh Sleep Quality Index is only measured at baseline.
Postpartum Partner Support Scale, (Dennis & Ross, 2006). The PPSS is a 24-item self-
report instrument to assess partner postpartum-specific support. Items are rated on a 4-point 
Likert-type scale (responses from 1—4) to produce a total score ranging from 24 to 96, with 
higher scores indicating higher levels of postpartum partner support. This scale demonstrated 
reliability with mothers during the postpartum period (Cronbach alpha = .96) and significantly 
distinguished between women with and without depressive symptoms at 8 weeks postpartum 
(Dennis & Ross, 2006).
Social Provisions Checklist (Davis, Morris, & Kraus, 1998). This is a 30-item measure of 
perceived support from the co-parent, specifically. The scale covers six provisions of support: 
guidance,  reliable  alliance,  reassurance  of  worth,  attachment,  social  integration,  and 
opportunity for nurturance. These provisions are influenced by the theoretical work of Weiss 
(1974; the provisions of social relationships). All items are rated on a 5-point scale for a total 
score of between 30—120, with higher scores indicating higher levels of support. This measure 
has been used in the early postpartum period (4 weeks) showing good reliability (Cronbach’s 
alpha = .82) and predictive  validity, successfully distinguishing between women with and 
without depressive symptoms at 8 weeks postpartum (Dennis & Ross, 2006). 
HHL Acceptability Scale. The investigators developed a list of 11 questions designed to 
assess participant satisfaction with the program on a scale of 1 (strongly disagree) to 5 (strongly 
agree). Open ended responses for participants to suggest alterations to the program are 
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included as  well.  As  this measure  has been designed specifically for  the current study, 
psychometric data are not available. Acceptability will be measured at six weeks and six months 
postpartum
Participant adherence. Adherence will be measured by the percentage of text messages 
recorded as opened (available through 3C Institute program delivery) by participants, as well as 
the percentage of weekly breastfeeding check-in texts participants respond to with a yes, or no 
response.
Hair cortisol. To provide convergent validity of the DASS-21 and other stress scales, we 
are collaborating with Dr. Stacey Doan of Claremont McKenna College to analyze hair samples 
and the correlation of this known biomarker of cortisol to the mother’s stated stress levels. We 
will share study ID number, deidentified hair samples, hair histories, and scores on coping 
behavior, partner support,  mood/stress, and sleep quality index scales with Dr. Doan for 
comparative analysis with hair cortisol levels. Hair cortisol measurement procedures will follow 
validated  methods (Dettenborn  et  al.,  2010;  Stalder  &  Kirschbaum,  2012).  Hair  cortisol 
collection is not required for participation in this study. All mother’s with at least 3 cm of hair 
who enroll in “Happy, Healthy, Loved” may opt to contribute a hair sample. The study staff 
member who explains the study and obtains the informed consent will collect the hair sample 
at the time the baseline questionnaires are obtained. At baseline, a small amount (15-30 mg) of 
hair from the posterior vertex of the head will be collected. Hair strands will then be cut into 3 
cm segments, which based on human scalp hair grows at approximately 1 cm per month 
(Kirschbaum, Tietze, Skoluda, & Dettenborn, 2009b), so each of the 3 cm sample will indexed 
cortisol output during the three trimesters of pregnancy  (D'Anna-Hernandez et al., 2011; 
Kirschbaum et al., 2009). If hair is less than 9 cm long, the analysis will include only the number 
of 3 cm segments available. The wash procedure and steroid extraction will be undertaken using 
high performance liquid chromatography–mass spectrometry (Gow, Thomson, Rieder, Van Uum, 
& Koren, 2010). Additionally, because washing, hair straightening or dying, and styling products 
may affect HCC (Gow et al., 2010), mothers will be asked about their hair histories to use as 
covariates in analysis along with hair sample. Hair histories include questions related to hair 
color, salon treatments, sunlight exposure, use of hair products, medications, creams, and hair 
pieces, style and indoor tanning habits. The samples will be sent to  Dr. Stacey Doan of 
Claremont McKenna College for analysis.   
Pasero-Opioid Induced Sedation Scale (POSS).  All participants who have had opioids for 
comfort within 6-hours of consenting will be assessed using the POSS scale. The POSS scale is 
used to determine a patient’s level of sedation before subsequent doses of pain medication. 
The scale ranges in S for “sleep, easy to arouse” to 4 which indicates somnolence. A score of 1-2 
indicates that the patient is awake or slightly drowsy but easily awakened. Only patients with 
scores of S, 1, or 2 will be consented for the study. 
D. Study Design
2. Recruitment Procedures: 
We plan to hire a study nurse to assist other study staff to recruit eligible participants at 
the  postpartum  unit of  Riverside  Methodist  Hospital,  Grant  Medical  Center, and  Doctors 
Hospital during the mother’s 2-3 day postpartum hospital stay during the study period. The 
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OhioHealth Institutional Review Board (IRB) will approve all study staff. Participant recruitment 
will follow procedures previously used in research with first time mothers at RMH (Henshaw et 
al., 2015) and the initial feasibility pilot trial for this proposed study. A daily census of patients 
will be reviewed by nursing staff to ensure that mothers with infants in the NICU and mothers 
who experienced infant loss will not be contacted. Using a standardized study recruitment script 
the study staff will introduce the study to the potential participant. If the patient shows interest, 
study staff will begin the informed consent process. The study staff will check the patient’s  
electronic record to determine when or if pain medication has been given within the last 6-
hours. If pain medication was taken the study staff member will assess the patient using the  
POSS scale and document the results in the medical record. Only patients with a POSS score of 
“S”, 1 or 2 may be consented. If the patient does not have a score of “S”, 1 or 2 on the POSS 
assessment, the study staff can return later to reassess. 
If the participant meets eligibility, the study staff will describe the study, and interested 
mothers will identify if they would like to participate together with their partner. If the co-
parent is in the room, a study description and consent will occur immediately. If not, the study 
staff will leave study materials for the mother and co-parent to discuss, and will set a time to 
return to the room. Only couples in which a partner is able to consent in person and visit the 
hospital will be included. The study staff member will bring an iPad for the participants to use 
for  completing  pre-intervention  surveys.  All  pre-intervention  and  study  surveys  will  be 
completed by accessing the REDcap online survey link on the iPad. No survey data will be stored 
on the iPad or other computer hard-drive. Survey data entered into REDCap via the iPad will be 
stored in the REDcap’s password-encrypted server. 
Participants will complete two mood questionnaires: the EPDS and the Mood Screener. 
Participants whose survey responses suggest they meet criteria for a current depressive episode 
will be provided with education and treatment resources for area providers. An automatic pop-
up message  is  coded to appear on the iPad survey when a mother  or  partner's survey 
indicates anything other than no risk for suicide. The initial surveys are completed on iPad 
before being randomized to the intervention or usual care group. The research team member 
who consented the patient will review the completed questionnaire before continuing to 
introduce the intervention or usual care instructions. The study nurse will collect the initial 
surveys and check for the coded message as soon as the participant completes the surveys. If a 
survey shows depression or  suicide risks, the  study staff will use  the following standard  
OhioHealth protocol. A patient (included or excluded from study) who reports suicidal ideation 
(a 1, 2, or 3 on question #10 of the EPDS or yes to the suicide items on Mood Screener), an in-
hospital behavioral health consult will be arranged by the assigned clinical nurse for further 
evaluation of suicide risk and treatment need. As mentioned, these policies are consistent with 
OhioHealth’s  approach  to  depression  screening  (currently  using  the  SAD  Persons;  scale-
Appendix  B).  Additionally,  their  primary  care  physicians  will  be  notified  of  the  patient’s 
condition in order for follow up to occur post discharge. 
Partners will also complete a baseline EPDS and Mood Screener, as part of the baseline 
survey (not eligibility screening). If partners report suicidal ideation, the level of risk will be 
assessed by the study staff at the time of survey completion. All cases with low/moderate risk 
will result in referral to a suicide hotline and immediate mental health referral. High risk 
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(potential immediate threat) cases will result in an emergency mental health referral (911) 
made with the participant’s knowledge. The details of this risk protocol are attached. If the 
partner’s survey results suggest they meet the criteria for current depressive episode, we will 
ask them for their primary care provider’s contact information so that we can notify them for 
follow-up. If the patient or partner do not have a primary care provider, we will refer them to 
the emergency department for evaluation and referral to the appropriate level of care.
The six week and six month surveys will have an automatic message appear at the end of 
the survey for the mother or partner to read if the suicidal ideation or depression score is 
elevated. The message states the following: “If your survey results show an elevated depression 
score you should contact your primary healthcare provider. If your survey suggest you are at 
risks for suicide or this is an emergency you should contact 911 or the suicide hotline phone 
number  1-800-SUICIDE  1-800-784-2433.  Survey  responses  will  be  reviewed  by  the 
research team daily and phone contact will be attempted within 24 hours of the survey receipt. 
Three attempts to reach the participant will be tried within 24-48 hours. The consent form will 
remind patients and partners that referrals and physician notification may occur to ensure 
optimal care. Patients will be informed that failure to accept the notification of a health care 
provider clause will render them ineligible for the study. 
3.    Randomization and Bias Reduction: 
The  study  statistician  will  provide  a  randomization  table.  Before  beginning  the 
recruitment  process  we  will  upload  the  table  into  the  REDCap  software.  We  set  the 
randomization for two groups; one for patients receiving the intervention of mobile text 
messaging and prompts to partners about ways they can support the mother, and one group to 
serve as a control. Following the participant’s agreement and consent to participate in the 
study, the member of the study staff who obtained the consent will provide an iPad to the 
patient and open the REDCap link so that the participant can begin their surveys. When the 
patient has finished the surveys, the study staff will log back into REDCap to verify the surveys 
are complete, following verification, the study staff member will click on the randomization tool 
to determine the patient’s treatment group. 
Study staff will inform the intervention participants that they will receive text messaging 
information for 6 weeks postpartum (4 per week), mapping closely with the tablet content that 
will provide reminders, resources, and encouragement associated with the three areas of 
education. Based on participants’ responses in the tablet program, the messages will be 
personalized to the motivations, preferences, and concerns that parents indicate in the tablet 
program.  All  program  delivery  will  be  managed  through  contracted  partnership  with  3C 
Institute,  specializing  in  behavioral  health  platforms  using  HIPAA-compliant  procedures. 
Development  of  the  initial  tablet-based  prototype  was  designed  in  consultation  with  an 
instructional technologist at Denison University who contributed to a user-friendly tool. The 
control  group  activities  consist  of  usual  care  at  RMH,  GMC,  and  DH  along  with  non-
breastfeeding text messages reporting infant developmental milestones over the first 6 weeks 
postpartum. All patients receive access to a lactation consultant during the hospital stay along 
with optional in-person class, instructional video, and information packet about breastfeeding. 
The remaining surveys will be pushed out through email automatically through REDCap six-
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weeks and six months after the first message treatment. 
After the participants complete the initial education modules and pre-surveys have 
finished, the study staff will set up the automated, one-way text program. Mothers and their 
participating  partners  will  receive  a  $25  pre-paid  gift card  following  the  initial  survey  
completion, a second $25 gift card following the 6-week follow up survey completion, and a  
third $25 gift card following the 6-months follow up survey completion. Therefore, each  
participant is eligible for a total of $75 in gift cards if they complete all surveys ($150 total per 
couple).
4. Intervention:
Happy Health Loved (Experimental Condition). The HHL program is comprised of the 
three topical areas described in Table 2. This information will be delivered via tablet to both 
parents during the postpartum hospital stay. For the next 6 weeks text messages (4 per week) 
mapping closely with the tablet content will provide reminders, resources, and encouragement 
associated with the three areas of education. Based on participants’ responses in the tablet 
program, the messages will be personalized to the motivations, preferences, and concerns that 
parents indicate in the tablet program. Example content is provided in Figure 2. All program 
delivery  will  be  managed  through  contracted  partnership  with  3C  Institute  (OhioHealth 
approved), specializing in behavioral health platforms using HIPAA-compliant procedures. 3C 
Institute is an award-winning research and development company founded in 2001 that brings 
research to practice to improve the health and well-being of people. The Institute creates, test 
and disseminates evidence-based programs and has received the Tibbetts Award from the Small 
Business Administration for technological excellence in 2014. 3C provides the platform for the 
tailored, automated text messaging for the study. 
Participants will be asked one yes/no question each week (“still breastfeeding? Text Y for 
yes, N for no”). Once a “no” response has been received from a participant, all remaining text 
messages will emphasize coping and partner support only rather than breastfeeding, in order to 
minimize any guilt or distress a mother may feel for discontinuing breastfeeding. This will occur 
automatically within the program. 
Data security. Participants assigned to the intervention condition will complete questions 
and activities within the online platform of Happy Healthy Loved, delivered on the HIPAA 
compliant, secure, encrypted platform delivered by 3C Institute (see support letter for details). 
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Goals
Example Activities
Viewing breastfeeding as learned skill
Other mothers’ modeling of challenge management  
Reflecting on successes and growth
Accomplishment feedback on breastfeeding success
Increase perceived support
Prompt partner to show active support 
Mutual support of self-care 
Prompts to both partners to mutually support self-care 
Behavioral activation
Prompt mother’s preferred rewarding activity
Realistic expectations of self 
Strategies for challenging negative thoughts 
modeling & 
feedback
partner 
support 
stress 
coping
Table 2: Outline of HHL goals and activities
 
Approved Date: October 5, 2020
Expiration Date: May 7, 2021
OhioHealth Corporation
Institutional Review Board 2

We  will  obtain  survey  data  from  mothers  and  their  partners  via  online  questionnaires 
completed using OhioHealth approved REDCcap software (https://www.project-redcap.org/). 
Participants will complete the surveys using iPads provided by the research team. 
Only the Principal Investigator (PI) and certain members of the research staff (e.g., study  
coordinator)  will  know  of  or  have  access  to  the  participants’  identities.  Privacy  and 
confidentiality will be maintained by assigning a study number to each participating mother-
partner dyad. HIPAA compliant, password protected REDCap database will be used to store 
participant survey information. Only approved study personnel will have access to study data 
and individually identifiable private information about human subjects. All study personnel with 
access to study data will be certified to conduct research with human subjects, and will be 
aware  of  the  importance  of  maintaining  strict  confidentiality.  REDCap  and  3C  Institute 
intervention data will not be linked online; rather, the four-digit participant ID number will be 
the only link between the two sources of information. REDCap and the 3C Institute platform will 
be password protected, and accessing the iPad without the correct password would not allow 
an unauthorized person to access participant data. 
The content and delivery of the text-message follow up will map closely with the content 
provided in the tablet-based materials. The intention is to provide reminders, resources, and 
encouragement associated with the three areas of education. Texts will be matched to mothers’ 
response  to questions  in the  educational module designed to identify her  strengths and 
preferred coping strategies. For example, a mother who identified during the initial module that 
walking has been a positive coping strategy for managing stress and mood in the past would get 
a text specifically encouraging her to make time for a walk, with or without baby. The partner 
would receive a corresponding text suggesting that walking is helpful for the mother, and 
encouraging the partner to provide support for this activity in one of two ways: offer to watch 
the baby while mother walks or go for a walk with the mother and baby. Messages will be sent 
four times per week.
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Participants will be instructed on how to unsubscribe from the program at any time 
using a text response of “unsubscribe.” Participants who unsubscribe will still receive the 6 week 
survey and will be contacted by the research team to learn whether they would like to withdraw 
from the study entirely or simply unsubscribe from the messages. 
Control group activities. The control group activities consist of usual care at the RMH, 
GMC, and DH care sites. The videos are part of the subscription program The Newborn Channel, 
and parents can choose videos on demand to watch on topics covering a variety of topics from 
postpartum depression to safely bathing a newborn and recovery steps post-cesarean section. 
Control group participants will document with a signature after they have watched Newborn 
Channel videos on breastfeeding, infant care basics, and postpartum depression (currently 
required of mothers before hospital discharge). The control group participants will be sent four 
text messages per week for the first six weeks as well, but the content of the texts will be non-
breastfeeding related. The content will instead summarize infant development facts. The text 
messages will be sent in order to separate the effect of receiving text messages from the effect 
of the active intervention content.
5. Confidentiality and Data Management: 
3C Institute privacy protections are included as an appendix detailing specific technology 
safeguards. All study personnel will be trained in ethical conduct of research and data will be 
protected  in  the  REDCap  and  3C  Institute  platforms.  Participants  would  be  informed 
immediately if such a breach were to occur and we would take every effort to recover and 
protect  the  information.  3C  Institute  specializes  in  mental  health  education  and  support 
applications, and has a history of creating secure platforms for individual use that are HIPAA 
compliant. OhioHealth Information Security (IS) is reviewing the 3C contract and platform to 
ensure privacy protections meet OhioHealth strict IS security mandates. 
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All paper informed consent documents and study log book materials will be stored in a 
locked file cabinet at each hospital location within a secured room in the maternity floor. The 
approved study staff will hold the key to the file cabinet. 
E. Statistical Analysis 
The intervention’s impact on the study’s primary outcomes will be evaluated using 
intent-to-treat  analysis  with  multiple  imputation  for  missing  follow  up  cases.  Outcomes, 
adjusting for baseline variables, will be analyzed using ANCOVA for continuous variables (self-
efficacy, partner support, and coping) and logistic regression for categorical variables (exclusive 
breastfeeding). To examine the extent in which increased partner support, and lower levels of 
stress would explain the effects of the intervention, two criteria will be used to establish 
whether  there  is  statistically  significant  mediation  in  the  model(MacKinnon,  Lockwood, 
Hoffman,  West, & Sheets, 2002; MacKinnon, Fairchild, & Fritz, 2007)  including  the joint 
significance of paths a ( i.e., the path from predictor to mediator) and b (i.e., the path from 
mediator to outcome variable) and the asymmetric distribution of the product confidence 
interval test for the product (a*b) of the coefficients a and b, which have both shown the best 
combination of power and avoidance of type 1 error compared to 12 alternative tests of 
mediation(MacKinnon et al., 2002; MacKinnon et al., 2007).
 We will use the regression-based approach described by Hayes to develop models that 
allow us to evaluate mediation (Hayes, 2008). The bootstrapping resampling method available 
in this approach provides an opportunity to run analyses that will approximate the sampling 
distribution to obtain confidence intervals (CIs) when variables are not normally distributed. 
With  regards  to  aims  3  and  4,  regression  (logistic  regression  for  dichotomous  outcome 
variables) analyses controlling for relevant covariates will be used to examine relations between 
hair cortisol levels and partner support, coping, self-efficacy, and breastfeeding rates. Because 
both high and low levels of cortisol have been indicated as signs of dysregulation (Miller, Chen, 
&  Zhou,  2007) ,  a  quadratic  term  will  be  added  to  the  model  to  examine  non-linear 
relationships. In addition, to these analyses, we will also use the mediation approach described 
above to explore the extent to which maternal mood may mediate the relations between 
cortisol and breastfeeding behaviors. 
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III.
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