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\begin{document}

\title{Postpartum home blood pressure monitoring and lifestyle intervention in
the first year after a hypertensive disorder of pregnancy: A pilot
feasibility trial}



\author[1]{Alisse Hauspurg}%
\author[2]{Ellen Seely}%
\author[3]{Janet Rich-Edwards}%
\author[1]{Christina Hayduchok}%
\author[1]{Samantha Bryan}%
\author[2]{Andrea Roche}%
\author[1]{Arun Jeyabalan}%
\author[1]{Esa Davis}%
\author[1]{Renee Hart}%
\author[4]{Jada Shirriel}%
\author[1]{Janet Catov}%
\affil[1]{University of Pittsburgh School of Medicine}%
\affil[2]{Brigham and Women's Hospital}%
\affil[3]{Harvard T.H. Chan School of Public Health}%
\affil[4]{Healthy Start, Inc}%


\vspace{-1em}



  
  \date{May 21, 2024}


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\selectlanguage{english}
\begin{abstract}
Objective: To test the feasibility of a randomized trial of home blood
pressure monitoring paired with a remote lifestyle intervention vs. home
blood pressure monitoring alone vs. control in individuals with a
hypertensive disorder of pregnancy in the first year postpartum. Design:
Single-blinded randomized clinical trial Setting: Two tertiary hospitals
and a community organization Population: Overweight and obese
individuals with a hypertensive disorder of pregnancy and without
pre-pregnancy hypertension or diabetes. Methods: We assessed the
feasibility of recruitment and retention of 150 participants to study
completion at one-year postpartum with randomization 1:1:1 into each
arm. Secondary aims were to test effects of the interventions on weight,
blood pressure and self-efficacy. Results: Over 23 months, we enrolled
148 of 400 eligible, screened individuals (37\%); 28\% Black or Other
race, and mean pre-pregnancy BMI of 33.4\selectlanguage{ngerman}±6.7 kg/m2. In total, 129 (87\%)
participants completed the one-year postpartum study visit. Overall,
22\% of participants developed stage 2 hypertension {[}\selectlanguage{english}[?]140/90 mmHg or
on anti-hypertensive medications{]} by one-year postpartum. Individuals
in the lifestyle intervention arm had a greater, non-significant
decrease in mean arterial pressure (MAP) compared to individuals in the
HBPM alone and control arm {[}mean change in MAP (95\%CI) -3.7(-6.5,
-0.9), -0.5(-1.5, 2.6), -1.0(-4.1, 2.2) mmHg{]}, respectively. There
were no differences in weight or self-efficacy by study arms.
Conclusion: In this pilot, randomized trial, we demonstrate feasibility
of HBPM paired with a lifestyle intervention in the first year
postpartum. We detected high rates of ongoing hypertension emphasizing
the need for effective interventions in this population.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{INTRODUCTION}

Hypertensive disorders of pregnancy (HDP), including gestational
hypertension and preeclampsia complicate 8-10\% of pregnancies in the
United States. The association of HDP with later-life cardiovascular
disease (CVD) is well-established and has been replicated in diverse
populations across multiple studies.(1--4) Recent data suggest 30-40\%
of previously normotensive individuals progress to chronic hypertension
in the first year following HDP, which is likely a key contributor to
CVD risk.(5,6) In overweight and obese individuals, that risk is further
amplified, with prior studies demonstrating that over 50\% have
sustained hypertension at one-year postpartum.(7) Despite this, few
interventions have been studied to mitigate risk in this population.(8)

Traditional in-person interventions, such as regular appointments and
counseling from a primary care doctor or nutritionist may promote
lifestyle changes in the general adult population, but this has not been
as successful for primary prevention in a postpartum population, likely
due to competing demands and time constraints.(9--11) However, following
a pregnancy complication, the immediate postpartum period is a time when
individuals may be particularly motivated to improve their health, both
before the next pregnancy and long-term.(12,13) Self-monitoring via home
blood pressure monitoring as a tool to lower blood pressure is supported
by robust evidence in the general adult population. When self-monitoring
of home blood pressure is combined with additional support (education,
counseling, individualized feedback, patient navigator), further
lowering of blood pressure is achieved in a general hypertensive
population.(14) Internet-based lifestyle interventions implemented in
the immediate postpartum period promote weight loss in individuals with
a history of gestational diabetes and show high engagement and retention
postpartum (15,16) but these are not well-studied in individuals after
HDP. Prior postpartum intervention studies have had high attrition
rates, which suggested that postpartum individuals may not be willing to
participate in intervention studies due to the competing demands of the
immediate postpartum period, highlighting the need for a feasibility
study prior to proceeding with a large-scale randomized trial.(17,18)

The initial Heart Health 4 Moms study developed a remote lifestyle
intervention that was internet-based and mobile-device compatible which
demonstrated improvement in knowledge of CVD risk and self-efficacy to
achieve a healthy diet and decreased physical inactivity among
predominantly white and highly educated postpartum individuals within
the first five years following a pregnancy complicated by
preeclampsia.(8) Our primary aim in this three-arm trial was to examine
the feasibility of conducting a randomized controlled trial comparing
home blood pressure monitoring plus the internet-based lifestyle
intervention, Heart Health 4 New Moms (HH4NM) compared to home blood
pressure monitoring alone compared to a control arm, in a racially and
socioeconomically diverse sample of overweight and obese individuals
with a hypertensive disorder of pregnancy in the first year postpartum.
Our secondary aims were to test whether the interventions (HH4NM +HBPM
or HPBM alone) would lower weight and blood pressure compared to
controls.

\textbf{METHODS}

\emph{Study recruitment}

Between June 2019 and May 2021, we recruited adult postpartum
individuals who had delivered within the past six months at one of two
tertiary care hospitals within a single hospital system (Magee-Womens
Hospital in Pittsburgh or Magee-Womens Hospital in Erie) or through our
partner community organization, Healthy Start, Inc. Healthy Start, Inc.
is a community-based organization that seeks to improve maternal and
child health, reduce poor birth outcomes and infant mortality as well as
eliminate perinatal health disparities in the Pittsburgh community.
Individuals were eligible if they had a pre-pregnancy body mass index
(BMI) in the overweight or obese range ([?]25 kg/m\textsuperscript{2}). If
pre-pregnancy weight was unknown, we used a weight measured clinically
in the first trimester of pregnancy. We enrolled participants between 6
weeks and 6 months postpartum if they had a pregnancy complicated by
gestational hypertension or preeclampsia according to American College
of Obstetricians and Gynecologists' (ACOG) criteria (19), were [?]18 years
of age, English-speaking and had access to a device with internet
connectivity. Individuals were excluded if they had a pre-pregnancy
history of diabetes, chronic hypertension or were noted to have elevated
blood pressure ([?]140 / 90 mmHg) before 20 weeks gestation, known
coronary artery disease, underlying chronic kidney disease
pre-pregnancy, autoimmune disease requiring medications, multifetal
gestation, stillbirth or neonatal death or were pregnant at the time of
enrollment. Inclusion criteria were evaluated through a phone or
in-person screen and medical record review by research staff.
Participants who became pregnant during the intervention were asked to
discontinue the intervention and were withdrawn from the study.

Participants who met inclusion criteria were either identified at the
time of delivery by the research study staff or in the postpartum period
during home visits by Community Health Workers at Health Start, Inc.
Eligible participants were identified by medical record review by the
study physician (AH) and pregnancy outcomes were adjudicated by two
independent physicians (AH\& AJ) using ACOG criteria for diagnosis of
gestational hypertension and preeclampsia.(19) Before March 2020,
eligible participants were recruited during their postpartum
hospitalization. After March 2020, due to the Covid-19 pandemic and
restrictions on in-person research activities at our institution, all
recruitment and study procedures were conducted remotely via phone and
video visits. Individuals who were eligible following medical record
review were contacted either in person or via a recruitment letter
(after March 2020). All participants provided written informed consent.

\emph{Control arm intervention}

The control arm received access to the Heart Health 4 New Moms control
website, which included publicly available information regarding
cardiovascular risk associated with preeclampsia and gestational
hypertension and lifestyle recommendations to prevent cardiovascular
disease from the American Heart Association and the Preeclampsia
Foundation.

\emph{HBPM arm intervention}

Participants in this arm received resources on the HH4NM website
available to the control arm plus a blood pressure monitor (iHealth,
Wireless Blood Pressure Monitor BP5). Arm circumference was measured at
the initial study visit and individuals received an appropriately sized
cuff. Participants received instruction from study staff on home
measurement of blood pressure and were asked to measure blood pressure
daily for one week out of each month, two measures in the morning and
two measures in the evening.(20) Participants were instructed on proper
measurement technique, including measuring in the seated position after
five minutes at rest. We used automated text messaging for reminders.
Individuals received summative information through the iHealth
application, as well as monthly summaries from study staff outlining the
number of measures provided, mean blood pressure values and their
comparisons to prior months.

\emph{HBPM + lifestyle intervention}

Participants in this arm received all interventions outlined above for
the HPBM arm, plus an electronic scale (iHealth Lite Wireless Scale,
model HS4) plus access to the HH4NM lifestyle program website, which
includes: audiovisual modules on healthy eating, modeled on the Dietary
Approaches to Stop Hypertension (DASH) diet, increasing physical
activity and identifying barriers to adopting a healthy lifestyle.(21)
Participants received online badges for completing modules and setting
goals through action plans and received personalized lifestyle coaching
from a registered dietician (ATR). Coaching was provided through six
scheduled calls and three scheduled emails, with interim communication
as initiated by participants. Interested participants were also enrolled
in a study-specific Facebook group to allow for peer support through
communication with each other and the lifestyle coach. Finally,
participants received access to a toolbox of additional resources,
including meal plans, recipes and instructional exercise videos that
could be done with an infant.

\emph{Randomization and Blinding}

Once the questionnaire and initial measurements were completed,
participants were randomized to either a control arm, HBPM alone or HBPM
plus HH4NM intervention in a 1:1:1 allocation. We utilized a block
randomization schema with block sizes of six generated by a blinded
statistician using the procedure PLAN in the statistical software
package SAS (SAS Institute, Inc., Cary, NC). Study staff and study
physicians and investigators interacting with prospective participants
during recruitment were blinded to which arm a participant would be
randomized. Study staff, who conducted the study visits and instructed
participants on study protocols were unblinded at the time of
randomization. Study physicians, investigators and the statistician
remained blinded until completion of all study visits.

\emph{Follow up and assessment of outcomes}

All participants underwent two assessments: baseline (pre-randomization;
6 weeks to 6 months postpartum) and at study completion (8-12 months
postpartum) after completing at least 6 months in the study. Enrolled
participants were emailed a link to a questionnaire, which was completed
before or at the time of the first two study visits. Before March 2020,
all participants underwent a study visit either in the Magee-Womens
Clinical and Translational Research Center (CTRC) or via home research
study visits, per participant preference. After March 2020 (due to COVID
pandemic restrictions), study visits were conducted remotely. At the
time of each assessment, participants completed online questionnaires
and measured blood pressure at rest, while sitting for at least 5
minutes. Blood pressure measures were either collected by study staff
(pre-pandemic) or observed by study staff virtually using a secured Zoom
room and were repeated three times. Blood pressures were measured using
either an iHealth, Wireless Blood Pressure Monitor BP5 or an A\&D UA-651
(A\&D Medical; San Jose, California) automatic upper arm blood pressure
monitor, both validated by Dabl Educational Trust and the British
Society for Hypertension for use in postpartum individuals. The mean of
the three measures was used in analysis. Mean arterial pressure was
calculated with the formula {[}systolic BP+(2*diastolic BP)/3{]}. Weight
measures were collected either by study staff during an in-person visit,
pre-pandemic, or were directly observed during a remote study visit
using a study-provided iHealth or Etekcity Digital Body Weight scale.
Individuals were weighed in light clothing without shoes at the time of
the study visit for both in-person and remote study visits. Participants
in all three arms received monthly emails thanking them for their
ongoing participation.

The primary objective of this pilot study was to evaluate the
feasibility of a randomized trial of home blood pressure monitoring vs
home blood pressure monitoring plus a lifestyle intervention vs control
in the first year postpartum. Feasibility of recruitment and retention
(proportion and 95\% CI) was assessed to study completion. Our
predefined measures for feasibility success included randomization of
8-10 participants per month and retention of [?]80\% of participants to
one-year postpartum, with a target to complete all recruitment at the
primary site during an 18-month period and recruitment at both sites
over a 24-month period. Our primary efficacy outcome was participant
weight at the second study visit, which was chosen as a patient-centered
outcome for postpartum individuals. Secondary outcomes included: 1)
blood pressure and change in blood pressure parameters across the study;
2) participant BMI and weight change across the study, 3) adherence to
intervention, 4) self-efficacy 5) prevalence of stage 1 and 2 HTN, 6)
use of anti-hypertensive medications at study completion and 7)
prevalence of lifestyle behaviors. Stage 1 and stage 2 hypertension were
defined using the 2017 American College of Cardiology / American Heart
Association guidelines - stage 1 hypertension: systolic BP 130-139 mmHg
or diastolic BP 80-89 mmHg and stage 2 hypertension: systolic BP [?]140
mmHg, diastolic BP [?]90 mmHg or requiring anti-hypertensive
medications.(22)

Self-efficacy towards achieving a healthy diet and level of physical
activity was assessed using an adapted version of the validated Sallis
Eating Habits Confidence Survey and Exercise Confidence Survey
scales.(23) We used the Pregnancy Physical Activity Questionnaire to
assess physical activity (type, duration, and frequency) and inactivity
(sedentary behavior), which is a validated questionnaire for women that
includes activities related to caring for young children. Time spent in
each activity weekly is multiplied by its intensity to yield the average
weekly energy expenditure.(24) Sodium intake was quantified using an
adapted version of the validated Sodium Screener developed by Block
(\selectlanguage{ngerman}©NutritionQuest 2011) to assess sodium intake as a continuous variable.
The Sodium Screener includes foods contributing to 80\% of sodium intake
in which there are five frequency response categories---from rarely or
never (assigned a value of 0) to every day (assigned a value of 4). The
cumulative score ranges from 0 to 67, with higher scores signifying
higher sodium intakes. For women, sodium intake less than 2300 mg per
day corresponds to scores between 18-24.(25)

A core outcome set (COS) does not exist for this research subject area,
thus a COS was not used when designing the trial.

\emph{Study sites}

As noted above, participants were enrolled from one of two hospital
sites or through Healthy Start, Inc. The initial trial protocol aimed to
enroll participants from a single, urban site. After the trial and
intervention were converted to be delivered fully remotely as a result
of the COVID-19 pandemic, the opportunity arose to enroll participants
from a second site (with a more rural population). As the primary
intention of this trial was feasibility, we opted to enroll 30
additional participants from this second site within our hospital system
to assess the feasibility of conducting this research at more than one
study location.

\emph{Patient involvement}

Preeclampsia survivors affiliated with the Preeclampsia Foundation were
involved in the design of all intervention content and website layouts
for the HH4NM intervention and adapted with key stakeholders at Healthy
Start, Inc. Study participants were involved in the review and
interpretation of results following study completion.

\emph{Statistical analysis}

We followed the intention-to-treat principle and included all randomized
participants. The target sample size for enrollment was 150 participants
to establish feasibility and given cost constraints, with 120 from the
primary site and 30 from the second site (as described above), for a
target of 50 in each of the three arms, following published guidelines
for feasibility studies.(26) A formal sample size calculation was not
performed as the primary objective of this study was to assess
feasibility. All analyses were performed in Stata IC 16 software package
(StataCorp LP, College Station, TX). Continuous variables are reported
as means with 95\% CI or SD (or medians with interquartile ranges
{[}IQR{]}) and categorical variables are reported as count and
proportions. Differences between arms were reported with 95\% confidence
intervals (95\% CI). An interim analysis was performed following
completion of the study at the primary study site as was initially
outlined in the study protocol prior to adding the second study site. To
evaluate the effect of the interventions (HH4NM + HBPM vs. HBPM alone
vs. control), we compared continuous variables between the three arms at
the second study visit (follow-up) using standard ANOVA. We also
compared the change in outcomes of interest between arms using ANOVA. At
the same time points, categorical data were compared between arms using
logistic regression and \selectlanguage{greek}χ\selectlanguage{english}\textsuperscript{2} test. In sub-group
analyses, we evaluated the feasibility and effects of the interventions
by race, pre-pregnancy BMI category, and type of hypertensive disorder
of pregnancy. We used all data available from randomized participants
without replacement of missing data.

\emph{Institutional approval}

The protocol was approved by the Institutional Review Board of the
University of Pittsburgh (STUDY18080007) and all participants provided
written informed consent. Study data were collected and managed using
REDCap electronic data capture tools hosted at the University of
Pittsburgh. The study protocol was registered with Clinicaltrials.gov
(NCT03749746) before any enrollment of participants. A data safety and
monitoring committee provided study oversight. There were no adverse
events reported.

\textbf{RESULTS}

\emph{Enrollment feasibility}

Between January 2019 and March 2021, 613 individuals were screened for
eligibility (Figure 1). Nine individuals were ineligible because they
did not meet study criteria, recruitment closed before screening was
done on 204 participants. Of the remaining individuals (n=400), 166
declined to participate and 86 were lost to follow up during the
recruitment process. We enrolled 148 of 400 eligible, screened
individuals (recruitment 37\%; 95\%CI 32.2\%, 41.9\%) over a 23-month
period (June 2019-May 2021). Demographic characteristics were overall
similar between enrolled versus unenrolled participants (Table S1).

\emph{Baseline characteristics}

Baseline characteristics of the 148 study participants are summarized in
Table 1. Participants were on average 30.8\selectlanguage{ngerman}± 5.1 years of age, 28\%
self-identified as Black or Other race with a mean pre-pregnancy BMI in
the obese range, 33.4±6.7 kg/m\textsuperscript{2} and 37\% were insured
through public health insurance. Participants delivered at 37.2 ± 3.1
weeks gestation (range 26.6-41.3 weeks) and mean infant birthweight was
2969 ± 786 grams. Mean gestational weight gain was 31.9 ± 18.7 pounds.
The majority of participants had a diagnosis of preeclampsia (n=93;
63\%) with 61\% (n=57) of these having severe features and 24\% (n=36)
delivered preterm (\textless{}37 weeks gestation). Additionally, 17
(12\%) individuals had pregnancies complicated by gestational diabetes.

Participants were enrolled at a mean of 10.5±6.1 weeks postpartum, with
101/148 (68\%) participants enrolled in the first three months
postpartum. Mean MAP at enrollment was 96±11mmHg (Table 2). Mean blood
pressure was 124±14 mmHg systolic and 82±10mmHg diastolic. Thirty-seven
(25\%) participants were on anti-hypertensive medications at the time of
enrollment, with a total of 99 (67\%) meeting criteria for stage 1
hypertension or greater at enrollment. Mean BMI at enrollment was
33.9±6.3 kg/m\textsuperscript{2}. At enrollment, 83 (56\%) participants
reported that they were feeding their baby breastmilk (expressed or
direct breastfeeding any amount).

\emph{Retention and adherence}

129 of 148 participants completed the second study visit (87.1\%
retention; 95\%CI 80.6\%, 91.6\%) at a mean of 10.9 ± 2.1 months
postpartum, with a mean participation time of 8.5 ± 2.0 months, which
did not differ by study arm (p=0.8). Four (3\%) participants became
pregnant before study completion. Retention ranged from 76\% in the
HH4NM +HBPM arm to 86\% in HBPM alone arm to 100\% in the control arm
and did not differ by self-reported race, type of hypertensive disorder,
pre-pregnancy BMI or study site. No difference was seen in the mean
number of blood pressures reported per month between the HBPM arm (mean
11.2± 9.9) and the HH4NM +HBPM arm (mean 10.9± 8.6; p=0.9). Participants
in the HH4NM +HBPM arm had a mean of 4.9 ± 3.3 phone contacts with the
lifestyle coach and 45 of 51 individuals (88\%) had at least one contact
with the lifestyle coach. During the study period, 44 of 51 participants
(86\%) accessed the study website at least once.

\emph{Effect of intervention weight and blood pressure}

There were no statistical differences in weight, BMI at follow up visit
or weight change from enrollment by study arm (Table 3). Overall,
participants retained a mean of 9.5 ± 18.5 pounds above their
pre-pregnancy weight. Thirty-eight (29\%) participants were back to
their pre-pregnancy weight by study completion. HBPM plus HH4NM
intervention led to a greater but not statistically significant decrease
in systolic, diastolic and mean arterial pressure (MAP) between the two
study visits (Table 3) when compared to HBPM alone and control {[}mean
change in MAP (95\%CI) -3.7(-6.5, -0.9), -0.4(-6.6, 1.0), -1.0(-4.1,
2.2) mmHg{]}, respectively. Differences in SBP and DBP were similar.
Overall, 75 (58\%) participants met criteria for stage 1 hypertension or
greater and 28 (22\%) met criteria for stage 2 hypertension with 13
(10\%) participants on anti-hypertensive medication at one-year
postpartum with no difference by study arm. Because of the small sample
size, the arms appeared to be less balanced by race and type of HDP.
Post-hoc, we examined whether these factors may have influenced our
findings. Adjustment for type of hypertensive disorder and race did not
change our estimates.

\emph{Effect of intervention on activity and diet}

Self-efficacy for healthy eating and physical activity levels was high
across all study arms at baseline (mean 4.27; 95\%CI 4.16, 4.39 for
healthy eating and mean 3.76; 95\%CI 3.62, 3.89 for activity). There was
no difference in self-efficacy for healthy eating and physical activity
levels at enrollment and follow up by study arm and no difference in the
change in self-efficacy towards healthy eating and activity across the
study. Participants in all three arms had a decrease in physical
inactivity time and increase in physical activity across the study
period with no difference by arm. Mean score on the Block Sodium
Screener increased during the study period in the control and HBPM alone
arm by 2.2±13.0, but decreased in the HH4NM + HBPM arm; -3.9 ± 12.2,
p=0.02 in post-hoc analysis of HH4NM + HBPM vs. other arms (HBPM alone
and control).

\textbf{DISCUSSION}

\emph{Main findings}

We demonstrate feasibility and high retention in a randomized trial of
postpartum home blood pressure monitoring plus a lifestyle intervention
among a diverse sample of overweight and obese individuals with HDP.
Importantly, while our study is not powered to show a statistical
difference in efficacy, we note that home blood pressure monitoring and
home blood pressure monitoring plus our lifestyle intervention arms had
lower mean arterial blood pressure compared to controls at one-year
postpartum and we detected statistically significant decreases in sodium
consumption associated with the full intervention. We also demonstrate a
high proportion of participants with ongoing hypertension at one-year
postpartum, with over half meeting criteria for stage 1 hypertension,
over 20\% with stage 2 hypertension and 10\% of participants still
requiring anti-hypertensive agents. We showed no statistical difference
in weight change across study arms, suggesting that any changes in blood
pressure were not secondary to weight loss in the intervention arms.
Particularly relevant in this population of overweight and obese
participants is the significant weight retention at one-year postpartum,
with less than 30\% of individuals returning to their pre-pregnancy
weight by study completion.

\emph{Interpretation}

Hypertensive disorders of pregnancy are associated with increased CVD
risk across multiple studies in diverse populations.(1,2) There is
compelling evidence that hypertension accounts for much of the CVD risk
following a hypertensive disorder of pregnancy, yet few interventions
have been studied to reduce progression to hypertension after a
hypertensive disorder of pregnancy.(27--29) Our previous work has
demonstrated that overweight and obese individuals have high rates of
ongoing hypertension at one-year postpartum and that overall individuals
may be particularly motivated to lower blood pressure following a
hypertensive disorder of pregnancy.(7)

Prior postpartum intervention studies have had high attrition rates,
which suggested that postpartum individuals may not be willing to
participate in intervention studies or engage in follow up care due to
the competing demands of the immediate postpartum period.(17,18) We
enrolled participants within the first six months postpartum and
retained almost 90\% to one-year. Our study design was adapted to meet
institutional regulatory requirements in the setting of the COVID-19
pandemic, and a remote approach to recruitment and study visits may in
fact be well suited to this population. Before transitioning to a remote
approach, we offered individuals two options for the first study visit,
in-office study visit or a home visit. Among these early participants,
58\% (n=26) opted for a home study visit, highlighting the potential
utility and desirability of this approach in the postpartum period as
well as the synergy of community partnering. Our overall enrollment
rates are in line with other studies of remote lifestyle interventions
for weight loss postpartum, but future work is warranted to understand
barriers to broaden enrollment of eligible participants. (30,31) Of the
individuals who declined to participate, reasons cited included that
being too busy or having the perception that their HDP ``wasn't that
bad'' so they didn't need an intervention. Future work should focus on
additional education and risk counseling in the postpartum period to
enhance understanding of future CV risk following a HDP. Additionally,
consideration of enhanced recruitment methods such as the use of social
media platforms or using technology to identify and recruit participants
and the use of community-based enrollment (e.g Women, Infants, Children
{[}WIC{]} or doula community programs) or integration with a clinical
postpartum visit may improve uptake of our intervention.

The parent Heart Health 4 Moms trial demonstrated improvement in
knowledge of CVD risk and self-efficacy to achieve a healthy diet and
decrease physical inactivity among predominantly white and highly
educated individuals within the first five years following a pregnancy
complicated by preeclampsia(8). The parent trial excluded individuals
with BP \selectlanguage{english}[?]140/90 mmHg, who were on anti-hypertensive agents or had a BMI
\selectlanguage{english}[?]40 kg/m\textsuperscript{2}. Compared to the initial trial, by design,
we enrolled a more diverse, higher-risk population, with 25\% on
anti-hypertensive agents and 25\% with a BP \selectlanguage{english}[?]140/90 mmHg at enrollment.
Importantly, we note that the majority of participants were able to come
off anti-hypertensive agents during the trial period.

Recent work has demonstrated that pharmaceutical interventions in the
immediate postpartum period may improve blood pressure and
cardiovascular function in the first year postpartum.(32,33) The SNAP-HT
trial randomized postpartum individuals who were on anti-hypertensive
agents following a hypertensive disorder of pregnancy to usual care with
in-office blood pressure assessments versus home blood pressure
monitoring plus management with systematic titration of
anti-hypertensive medications in the postpartum period. Cairns and
colleagues found that this approach was feasible and resulted in
improved diastolic blood pressure with a lowering of 4.5mmHg seen in the
intervention group up to 6 months postpartum.(33) Similarly, individuals
with preterm preeclampsia randomized to postpartum enalapril have
improved diastolic function and left ventricular remodeling at 6 months
postpartum when compared to individuals randomized to placebo.(32) These
studies suggest that the immediate postpartum period may be particularly
important for cardiovascular remodeling and that interventions in this
period may improve both short and long-term cardiovascular risk.

Despite promising data in the non-pregnant population, few studies have
investigated self-monitoring of BP combined with additional support. Our
study found a modest lowering of blood pressure in the intervention
arms. Given the evidence that modest BP elevations among young adults
(\textless{}40 years) are linked to significantly higher risk for
subsequent CV disease events when compared with those with normal BP,
modest BP improvements may be important.(34) Although our findings are
promising, the ongoing high rates of hypertension and need for
anti-hypertensive medication suggest the potential need for
interventions beyond home monitoring and lifestyle support in a
proportion of this population. Thus, postpartum monitoring may help
stratify groups for lifestyle versus more intensive follow-up to improve
BP control. Our findings support the need for larger studies with longer
follow up postpartum. One major limitation to interventions beyond the
immediate postpartum period is access to care. For individuals with
public health insurance, in many states within the United States,
Medicaid coverage lasts only through sixty days postpartum. The high
rates of ongoing hypertension in our population highlight the critical
need for Medicaid expansion to at least one year postpartum and the
importance of successful transitions of care postpartum from the
obstetrician to the primary care physician.

We saw no improvement in self-efficacy towards healthy diet and activity
or levels of physical activity and inactivity in the HH4NM + HBPM arm,
perhaps related to the high levels of self-efficacy at baseline. We also
saw no significant effect of our intervention on weight change. Prior
studies have shown that diet alone and diet paired with exercise after
delivery lead to greater weight loss compared to usual care in a general
postpartum population, not specifically in overweight or obese
individuals following a hypertensive disorder of pregnancy. A
meta-analysis of 7 trials demonstrated that diet combined with exercise
was significantly associated with postpartum weight loss with a mean
difference of 1.93 kg.(35) The dietary counseling in our intervention
was centered around implementing a DASH diet, as such, we note that
total daily sodium consumption, as measured by the Block Sodium Screener
decreased in the HH4NM + HBPM arm compared to the other two arms.
Consistent with a non-pregnant and postpartum population, we found that
higher sodium intake as assessed with the Sodium Screener was associated
with higher blood pressure and that individuals with persistent
hypertension at the conclusion of the study reported higher sodium
intake.(36--38) These findings support the possibility of lower sodium
intake leading to a greater reduction in blood pressure in the
intervention arm of our study and warrant further investigation with
more robust assessments such as urinary sodium excretion. This could be
relevant, as a recent study in individuals approximately five years
postpartum found that those with a history of preeclampsia have an
impaired ability to adapt their arterial stiffness (as assessed by pulse
wave velocity) in response to a change in sodium intake when compared to
those with a history of normal pregnancy.(39)

\emph{Strengths and limitations}

Given the pilot nature of this study, we were not powered to detect
statistically significant changes in weight or blood pressure associated
with our intervention. As such, our study is limited by the small sample
size, and an overall enrollment of 37\% of eligible, screened
individuals, limiting its generalizability. Additionally, those who
enrolled were more likely to have a pregnancy complicated by
preeclampsia with severe features compared to those who did not enroll.
Eligibility for the study required individuals to have a device with
internet access, which may have limited the economic diversity of
individuals eligible to participate, although we note that no one who
declined to participate cited lack of access to internet as a reason at
our primary site, but two individuals of the 102 screened (2\%) at our
secondary site declined to participate due to unreliable phone /
internet service and lack of access to an appropriate device. These
issues related to lack of access to broadband internet likely
disproportionately impact rural populations and limit the
generalizability of our intervention. In the future, engagement with
such an intervention may be increased with the use of an application
(app), simple text message reporting of blood pressures or with
integration into clinical care. Much like the parent HH4M study, the
control arm likely received more information than most receive in
``usual care,'' as prior studies have demonstrated that most clinicians
and patients are either unaware or do not communicate the increased risk
of CVD to postpartum individuals with a history of hypertensive
disorder.(12,40) Our physical activity assessments were based on
participant recall and subjective report, rather than objectively
obtained data, such as using actigraphy, and may have been too
insensitive to measure modest change. Given the global COVID-19
pandemic, we chose to pivot our approach to remote recruitment and study
visits and add a second study site, with a change in our protocol after
recruitment of approximately one-third of our planned sample size. In
addition, we were unable to assess if there may have been COVID-related
impacts on our findings.

\emph{Conclusion}

Our results demonstrated high engagement and retention of overweight and
obese postpartum individuals in a randomized control trial in the first
year following a hypertensive disorder of pregnancy. We found that home
blood pressure monitoring (HBPM) in combination with a lifestyle
intervention showed a trend of lower blood pressure and significantly
greater decrease in sodium intake in this high-risk population. Our
findings warrant confirmation with a larger trial powered to show
differences in blood pressure and weight outcomes. We detected high
rates of ongoing hypertension and significant weight retention
postpartum, suggesting that interventions beyond HBPM and lifestyle
coaching may be needed to lower blood pressure and support weight loss.

\textbf{FUNDING}

This work was supported by the Jewish Healthcare Foundation, Amy Roberts
Health Promotion Award, by funds from Magee-Womens Research Institute's
Erie initiative, The Erie Community Foundation and Hamot Health
Foundation and by NIH/ORWH Building Interdisciplinary Research Careers
in Women's Health (BIRCWH) NIH K12HD043441 to AH. Dr Esa Davis is a
member of the US Preventive Services Task Force (USPSTF); this article
does not necessarily represent the views and polices of the USPSTF.



\textbf{ETHICS APPROVAL}

The protocol was approved by the Institutional Review Board of the
University of Pittsburgh (STUDY18080007) on January 9, 2019 and all
participants provided written informed consent.

\textbf{CONTRIBUTION TO AUTHORSHIP}

AH: Substantial contributions to the conception, design, acquisition,
analysis and interpretation of data. Drafting the manuscript and
manuscript revisions. Final approval of the work and agreement to be
accountable for all aspects of the work.

EWS: Substantial contributions to the design, analysis and
interpretation of data. Substantial contribution to manuscript
revisions. Final approval of the work and agreement to be accountable
for all aspects of the work.

JRE: Substantial contributions to the design, analysis and
interpretation of data. Substantial contribution to manuscript
revisions. Final approval of the work and agreement to be accountable
for all aspects of the work.

CH: Substantial contributions to the design, and acquisition of data.
Substantial contribution to manuscript revisions. Final approval of the
work and agreement to be accountable for all aspects of the work.

SB: Substantial contributions to the acquisition, analysis and
interpretation of data. Substantial contribution to manuscript
revisions. Final approval of the work and agreement to be accountable
for all aspects of the work.

ATR: Substantial contributions to the conception, design, and
acquisition of data. Substantial contribution to manuscript revisions.
Final approval of the work and agreement to be accountable for all
aspects of the work.

AJ: Substantial contributions to the design, analysis and interpretation
of data. Substantial contribution to manuscript revisions. Final
approval of the work and agreement to be accountable for all aspects of
the work.

ED: Substantial contributions to the analysis and interpretation of
data. Substantial contribution to manuscript revisions. Final approval
of the work and agreement to be accountable for all aspects of the work.

RH: Substantial contributions to the acquisition of data. Substantial
contribution to manuscript revisions. Final approval of the work and
agreement to be accountable for all aspects of the work.

JS: Substantial contributions to the conception, design, and acquisition
of data. Substantial contribution to manuscript revisions. Final
approval of the work and agreement to be accountable for all aspects of
the work.

JC: Substantial contributions to the conception, design, acquisition,
analysis and interpretation of data. Drafting the manuscript and
manuscript revisions. Final approval of the work and agreement to be
accountable for all aspects of the work.

\textbf{DISCLOSURE OF INTERESTS}

Dr Esa Davis is a member of the US Preventive Services Task Force
(USPSTF); this article does not necessarily represent the views and
polices of the USPSTF.

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