Prenatal Interventions to Promote Exclusive Breastfeeding

Relevance:

This research is aligned with efforts to decrease infant mortality and associated racial
disparities via culturally competent interventions, and our aim is that it will be possible
to model a larger intervention trial using the data generated in this pilot study. The
project showcases work which is clinically meaningful, addresses an important racial health
disparity in a vulnerable population (predominantly African-American expectant women) and is
allied with hospital quality measures (PC-05, exclusive breastfeeding in hospital).

Background:

Exclusive breastfeeding through age 6 months is the optimal infant feeding method due to
lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding
in-hospital is critical because in-hospital formula supplementation doubles risk of
non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding
initiation rates have increased at our inner-city Baby Friendly - designated maternity
hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant
nutrition and care, 2015) demonstrate this is a national problem, with >50% of surveyed
hospitals endorsing supplementation of "10-49%" of breastfed infants.

Study Objective and Aims:

The study objective is to evaluate acceptance/satisfaction of 2 prenatal interventions
(breastfeeding champion and positive messaging) and to determine if these affect exclusive
breastfeeding intention and practice.

Study Aims are "1." To determine if intention to exclusively breastfeed changes from before
to after the intervention is implemented "2." To determine the acceptance and satisfaction of
the interventions "3." To determine and compare the rates of exclusive breastfeeding
in-hospital and at 2-weeks postpartum among women who received the champion and positive
messaging interventions

Methods:

Study Design: The study is a pretest-posttest sequential group design chosen to evaluate the
effect of two prenatal breastfeeding interventions on exclusive breastfeeding intention.
Intervention A (Breastfeeding Champion) and Intervention B (Positive Messaging) will be
administered during months 1 and 2, respectively, of the study.

Population and Setting: The setting is University Hospitals MacDonald Women's Hospital, an
academic tertiary care birthing center in urban Cleveland, OH with approximately 3,800
deliveries per year. The eligible population includes expectant women ages 14 years and up
(with guardian present if ages 14-17 years) who are attending a prenatal visit at an on-site
clinic and have completed required breastfeeding education presented at or before 28 weeks of
gestation. The clinics serve a predominantly African-American WIC-eligible population.

Interventions: Both interventions use a secured and protected iPad, and the total interaction
with the participant will take about 10 minutes. Intervention A utilizes information about
Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and
scroll through the content and will receive a follow up handout and encouragement to select a
Champion. Intervention B utilizes positive messaging from several sources and is modelled on
the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs
which each reveal an informational statement about exclusive breastfeeding benefits and tips,
followed by receipt of a summary handout.

Data Collection: After informed consent is obtained, sociodemographic information and a
pretest to include feeding intention will be administered. Then following the 5-8 minute
iPad-based intervention, a short posttest will be administered, which asks a Likert based
question about intervention satisfaction and about feeding intention post-intervention.
Postpartum, actual feeding method in hospital and at 2 weeks will be gathered by chart
review. REDCap will be utilized for data entry.

Outcome Measures: These will reflect the aims:

"1." Intention to exclusively breastfeed post-intervention "2." Likert-based satisfaction
with intervention received "3." Rates of exclusive breastfeeding in-hospital and at 2 weeks
post-partum

Data Collection Tools: These were created by the study team.

Data analysis and Sample Size considerations:

Sample size - Aim #1 of the study is to determine if intention to exclusively breastfeed
changes from before to after the interventions are implemented. There are no published data
on this question utilizing these interventions with which to formulate a hypothesis and
perform the requisite sample size to test that hypothesis. This will be considered a
hypothesis generating study and feasibility of enrollment will determine the sample size. We
will approach all eligible women during 2-month study period. We anticipate that
approximately 31 women per week will be eligible, of whom approximately 80% will agree to
participate, and over a 2-month study period, 250 women could be enrolled.

Data analysis - Nominal variables will be described using frequencies and percentages.
Normally distributed continuous variables will be described using means and standard
deviations, and non-normally distributed continuous variables will be described using medians
and IQRs (interquartile ranges). We will compare nominal variables, e.g. those who received
differing interventions (champion versus positive messaging) using Chi squared analyses or
Fisher's exact test as appropriate. Distributionally appropriate two-sample tests will be
used to compare continuous variables. Additional analyses may be carried out as the data
indicate, and will be considered exploratory.

Inclusion Criteria:

- Expectant women receiving prenatal care at UH MacDonald Women's Health Clinic or
MAC1200 CLinic

- Completed required breastfeeding education presented at or before 28 weeks of
gestation

- Age 14 - 17 years must have guardian/parent present who consents to teen
participation, and teen must then assent to participation

- Ages 18 years and older must consent to participate

Exclusion Criteria:

- Medical indication for use of formula only after delivery including HIV+ or will
require chemotherapy treatment