Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03167073 |
| Other study ID # |
201704147 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 6, 2017 |
| Est. completion date |
July 31, 2019 |
Study information
| Verified date |
July 2021 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Breastfed babies have significant health benefits extending beyond infancy, including lower
rates of childhood obesity and infection. Mothers who breastfeeding also have health
benefits, including increased rates of postpartum weight loss. Low-income women are less
likely to breastfeed comparatively; this disparity may be due to misconceptions about
breastfeeding benefits or poor social support. Based on survey results and focus groups of
low-income women, the investigators designed a novel smart-phone application to confront
barriers women perceived prevented them from breastfeeding and propose the first-ever
randomized controlled trial describing the impact a smart phone app has on postpartum weight
loss and breastfeeding rates among low-income women.
Description:
Breastfed babies have fewer childhood infections than formula-fed babies, and women who
breastfeed have a reduced risk of cardiovascular disease and increased rates of postpartum
weight loss. Thus, the American College of Obstetricians and Gynecologists (ACOG) recommends
six months of exclusive breastfeeding after birth. Nationally, 75% of women initiate
breastfeeding, but only 59% of Black women, 53% of teenagers, and 66% of women in the Special
Supplemental Nutrition Program for Women, Infants, and Children breastfeed. Unpublished
internal data suggest that, while the breastfeeding initiation rate for women receiving
prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher than the national average
(89%), by postpartum day #2, only 34% exclusively breastfeed. Reasons for this precipitous
decline in breastfeeding are not fully understood but include misconceptions about
breastfeeding benefits and poor social support.
This study would be the first-ever randomized controlled trial describing the impact that a
smart phone application (app) has on breastfeeding rates and thus postpartum weight loss
among low-income women. In this study's first phase, a previously well-validated
questionnaire was used to identify barriers that low-income urban women perceived as
preventing breastfeeding initiation or continuation. In the second phase, these data-as well
as input from neonatologists, certified lactation consultants, and focus groups of low-income
pregnant women-were used to create a smart phone application (app) to promote breastfeeding
called Breastfeeding Friend (BFF). The investigators chose an app to provide breastfeeding
support for two reasons. First, nearly two-thirds of American adults, and 90% of those under
the age of 29, have smart phones. Second, more than two-thirds of Americans with smart phones
use them to obtain health information via new media (blogs, websites, and apps). Among
low-income women, physician-designed new media have improved intrauterine device uptake rates
and decreased rates of postpartum smoking. BFF will serve as a virtual lactation consultant,
increasing breastfeeding knowledge while providing interactive assistance and access to
in-person resources. By providing women with more breastfeeding support, this app could
increase postpartum weight loss by decreasing a significant health disparity.
