Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Phase: NA
Conditions: Breastfeeding
Sponsor: Washington University School of Medicine

 
 
Official Title of the Study:  Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates 
among Low-income Urban Women 
 
NCT ID: 201704147 
 
Principal Investigator: Adam Lewkowitz, MD, Maternal-Fetal Medicine Fellow at Washington University School of 
Medicine in St. Louis 
Co-Investigator: Alison Cahill, MD, MSCI, Associate Professor, Director, Division of Maternal-Fetal Medicine, Department 
of Obstetrics & Gynecology at Washington University School of Medicine in St. Louis 
 
 
 
 

Adam Lewkowitz, MD, Maternal-Fetal Medicine Fellow 
Alison Cahill, MD, MSCI, Associate Professor, Director, Division of Maternal-Fetal Medicine, Department of Obstetrics & 
Gynecology 
 
Final version: June 15, 2017 
 
BACKGROUND AND OVERVIEW 
The high rate of obesity in the United States is a significant health concern for people of all ages. For example, 
nearly 1 in 3 children ages 2–19 and roughly half of reproductive-age women are overweight or obese. Notably, these 
rates are highest among low-income populations. Obesity and overweight put women and children at increased risk of 
numerous poor health outcomes, including cardiovascular disease and diabetes. Thus, we must identify interventions 
that can promote weight loss and improve health, especially among low-income populations.  
Breastfeeding is a simple intervention that is protective against childhood obesity and beneficial for long-term 
neurodevelopment, immunity, nutrition, and overall health. Breastfeeding is also beneficial to mothers: women who 
breastfeed have long-term cardiovascular health benefits and lose more weight by six months postpartum than those 
who don’t breastfeed. For these and many other reasons, numerous public health organizations are focused on 
increasing initiation and continuation of breastfeeding, particularly exclusive breastfeeding. However, although 75% of 
women initiate breastfeeding nationally, only 59% of African-American women and 53% of teenagers do so, and these 
rates may be even lower among low-income urban women. For example, our unpublished data demonstrate that only 
34% of Medicaid recipients receiving prenatal care at Barnes-Jewish Hospital (BJH) exclusively breastfeed by two days 
postpartum. This low rate of exclusive breastfeeding is particularly notable given that BJH is a Baby Friendly Hospital, 
which means the BJH Obstetrics unit has met a rigorous international standard shown to optimize breastfeeding 
initiation and continuation. 
The low breastfeeding rate among low-income women is attributed, in part, to misconceptions about 
breastfeeding benefits and poor social support. To overcome these barriers, we propose the first-ever randomized 
controlled trial assessing the impact of a smart phone application (app) on breastfeeding rates among low-income 
women. We chose an app because nearly 66% of American adults and 90% of those under the age of 29 have smart 
phones, and over 66% of Americans with smart phones use them to obtain health information via new media (blogs, 
websites, and apps). Additionally, physician-designed new media interventions for low-income women have improved 
intrauterine device uptake rates, increased weight loss, and decreased rates of postpartum smoking. To develop our app 
– Breastfeeding Friend (BFF) – we first used a well-validated survey to identify barriers low-income urban women 
perceive as preventing them from breastfeeding. Next, we used these data, and input from neonatologists, certified 
lactation consultants, and focus groups of low-income pregnant women, to create BFF. BFF functions as a virtual 
lactation consultant, increasing breastfeeding knowledge while providing interactive assistance and access to in-person 
resources. Here, we will test the ability of BFF to increase rates of breastfeeding and promote postpartum weight loss. 
 
RESEARCH DESIGN 
Objective(s): To assess the effects that a novel smartphone application has on breastfeeding rates and postpartum 
weight loss among low-income women 
 
Background: Prior metaanalyses have demonstrated that the highest increases in breastfeeding rates occur from 
individual-level breastfeeding education and support interventions available both during pregnancy and after delivery. 
Thus, we will recruit women during their third trimester of pregnancy and expose half of them to BFF, which provides 
individual-level educational and support, for one month during pregnancy and three months postpartum. Our overall 
hypothesis is that BFF users will have higher rates of breastfeeding and more postpartum weight loss than those in the 
control group. To provide the first data on the ability of a new media intervention to increase breastfeeding and 
postpartum weight loss among low-income women, we will pursue three specific aims: 
Specific Aim 1: Determine the effects of BFF on exclusive breastfeeding rates at two days postpartum.  
Hypothesis: Exposure to BFF will increase rates of exclusive breastfeeding at two days postpartum.  
Specific Aim 2: Assess the ability of BFF to increase postpartum weight loss.  
Hypothesis: Exposure to BFF will increase maternal weight loss by six months postpartum. 
Specific Aim 3: Determine the impact of BFF on breastfeeding from two days to six months postpartum.  

Adam Lewkowitz, MD, Maternal-Fetal Medicine Fellow 
Alison Cahill, MD, MSCI, Associate Professor, Director, Division of Maternal-Fetal Medicine, Department of Obstetrics & 
Gynecology 
 
Final version: June 15, 2017 
Hypothesis: Exposure to BFF will increase rates of non-exclusive breastfeeding at two days postpartum and 
exclusive breastfeeding at three weeks, three months, and six months postpartum. 
 
 
Study Design: Randomized controlled trial. 
 
Primary Outcome: Exclusive breastfeeding on postpartum day 2 
 
Secondary Outcomes: Breastfeeding initiation; exclusive and non-exclusive breastfeeding at 6 weeks, 3 months, and 6 
months after delivery; non-exclusive breastfeeding at 2 days postpartum; timing of formula initiation; postpartum 
weight loss; patient-reported best breastfeeding or pumping support tool during and after hospitalization 
 
Subject selection: Women will be included if they are nulliparous, plan to deliver at the clinical site and have singleton 
pregnancies without known severe fetal malformations or genetic conditions at 36 weeks’ gestation. Women will be 
excluded if they have a contraindication to breastfeeding.  
 
Randomization and Treatment: Patients meeting inclusion criteria will be enrolled, provided a complimentary 
smartphone, and randomized in a 1:1 ratio using computer generated randomizaed sequence to one of the two 
treatment protocols: 
1) BreastFeeding Friend (BFF): a novel smartphone application with on-demand videos on breastfeeding and 
educational support for infant development. 
2) A skeleton app: designed to look similar to BFF, the skeleton app will contain only digital breastfeeding handouts 
provided in routine prenatal care 
Methods: Nulliparous women with singleton pregnancies will be recruited at 36 weeks’ gestation at their routine 
Obstetric appointments at the prenatal clinic at the Center for Outpatient Health. Consenting women will complete an 
intake questionnaire to obtain sociodemographic information as well as self-reported prepregnancy weight, height, and 
breastfeeding intentions. They will then be randomized into two groups: BFF and a dummy app. The dummy app looks 
identical to BFF but contains only the limited breastfeeding content available during routine prenatal care. Each 
participant will receive a complimentary Android phone with three months of prepaid internet service. Sprint has heavily 
discounted smart phones and internet plans for use in this study. At two days, three weeks, three months, and six 
months postpartum, participants will complete telephone questionnaires derived from the Infant Feeding Practices 
Study II, a well-validated survey created by the Centers for Disease Control. This survey has been slightly modified to 
better target the study’s breastfeeding and weight-loss aims. Women will also be weighed on postpartum day two to 
obtain data on their gestational weight gain. The six-month follow-up questionnaire prompts participants to weigh 
themselves during the survey. Postpartum weight loss will be obtained by subtracting the reported weight at six months 
postpartum from the weight measured in the hospital on postpartum day two.  
 
Sample size: 170 women over an estimated 12 months 
 
Sample size justification: Our study will include 170 patients: 85 randomized to BFF and 85 randomized to a dummy 
app. Our statistical power estimates assumed a baseline rate of exclusive breastfeeding of 34%. A sample size of 79 
women in each group (anticipating 6 will be lost to follow-up) will afford 80% power to detect a 65% increase in 
exclusive breastfeeding at two days postpartum. Assuming a baseline postpartum weight loss of 10 kilograms by six 
months postpartum, our study population will also afford us 80% power to detect a difference in weight loss of two 
kilograms between women randomized to BFF and those randomized to the dummy app.  
 
Statistical Analysis Plan: Primary analysis will follow intention-to-treat analysis. Dichotomous endpoints including 
breastfeeding at two days postpartum and exclusive breastfeeding will be analyzed by using chi-square tests. 
Continuous measures including duration of exclusive breastfeeding, duration of any breastfeeding, and maternal weight 

Adam Lewkowitz, MD, Maternal-Fetal Medicine Fellow 
Alison Cahill, MD, MSCI, Associate Professor, Director, Division of Maternal-Fetal Medicine, Department of Obstetrics & 
Gynecology 
 
Final version: June 15, 2017 
loss will be analyzed by using Student’s t-test. We will calculate crude and unadjusted risk estimates and differences. We 
will use multivariable logistic regression to adjust for potential confounders.  
 
COMMUNITY BASIS 
Our study takes place in the predominantly low-income population of women who receive prenatal care at the Center 
for Outpatient Health. These women have significantly lower rates of breastfeeding than do higher-income women and 
have higher rates of obesity, putting them and their infants at increased risk of adverse health outcomes. If the trial 
proposed here demonstrates that Breastfeeding Friend improves breastfeeding rates among low-income women, then 
the Missouri Foundation for Health has encouraged us to apply to them for funding to provide the app free-of-charge to 
low-income women throughout Missouri. Because breastfeeding has significant health benefits extending beyond 
infancy, including lower rates of childhood obesity and higher rates of postpartum weight loss, widespread 
implementation of BFF could improve long-term health for low-income women and their children in our state. 
 
RELATIONSHIP TO OBESITY PREVENTION OR TREATMENT 
Obesity is a substantial public health problem in the United States that disproportionately affects low-income women. 
Compared to infants born to normal-weight women, those born to obese mothers have a higher risk of becoming obese, 
developing early-onset insulin resistance and diabetes, and having early cardiovascular disease, resulting in a cycle of 
maternal and offspring obesity and metabolic disease. Breastfeeding has significant benefits for infant health outcomes, 
including appropriate growth and weight gain, and has been proposed as a mechanism to decrease child obesity. 
Breastfeeding also increases rates of maternal weight loss postpartum. However, low-income women are less likely than 
moderate- and high-income women to breastfeed. This proposal—the first of its kind—will test an intervention to 
increase breastfeeding rates in this high-needs population, potentially resulting in improved neonatal and maternal 
health outcomes. If this study demonstrates that BFF improves breastfeeding rates, future work will be directed toward 
statewide dissemination, thereby improving the health of Missouri's low-income women and their children.