Clinical trial NCT03167073: Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Official title: Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: smartphone application
low-income women
breastfeeding
health education
health disparities
postpartum weight loss
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive a complementary android phone with 3 months of complementary internet service upon enrollment at approximately 36 weeks gestation. Women will be randomized to receiving Breastfeeding Friend (BFF; the intervention) or a dummy app (control), which looks identical to BFF but contains limited breastfeeding content available during routine prenatal care.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* nulliparous women with non-anomalous singleton pregnancies who speak English and do not have contraindication for breastfeeding. They must receive prenatal care at the Washington University in St. Louis's Center for Outpatient Health, the Medicaid clinic. Recruitment will occur at around 36 weeks gestation.

Exclusion Criteria:

* multiparous women with contraindications to breastfeeding, multiple gestations, an anomalous fetus, or who do not speak English

Primary outcomes:
measure: Number of Participants Breastfeeding Without Formula Supplementation
timeFrame: Postpartum day number 2
Secondary outcomes:
measure: Postpartum Weight Loss
timeFrame: Participants will be weighed in-person on postpartum day 2. Survey at postpartum month 6 will prompt participant to weigh herself and include this weight on the survey.
measure: Number of Participants Breastfeeding Without Formula Supplementation
timeFrame: postpartum week 6
measure: Number of Participants Breastfeeding Without Formula Supplementation
timeFrame: postpartum month 3
measure: Number of Participants Breastfeeding Without Formula Supplementation
timeFrame: postpartum month 6
measure: Number of Participants Breastfeeding With or Without Formula Supplementation
timeFrame: postpartum day 2
measure: Number of Participants Breastfeeding With or Without Formula Supplementation
timeFrame: postpartum week 6
measure: Number of Participants Breastfeeding With or Without Formula Supplementation
timeFrame: postpartum month 3
measure: Number of Participants Breastfeeding With or Without Formula Supplementation
timeFrame: postpartum month 6
Other outcomes:
measure: Number of Participants Reporting That App is Best Breastfeeding Resource
timeFrame: postpartum week 6
Locations:
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Adam K Lewkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffin LB, Lopez JD, Ranney ML, Macones GA, Cahill AG, Lewkowitz AK. Effect of Novel Breastfeeding Smartphone Applications on Breastfeeding Rates. Breastfeed Med. 2021 Aug;16(8):614-623. doi: 10.1089/bfm.2021.0012. Epub 2021 Apr 7.
citation: Lewkowitz AK, Lopez JD, Carter EB, Duckham H, Strickland T, Macones GA, Cahill AG. Impact of a novel smartphone application on low-income, first-time mothers' breastfeeding rates: a randomized controlled trial. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100143. doi: 10.1016/j.ajogmf.2020.100143. Epub 2020 May 17.
citation: Lewkowitz AK, Lopez JD, Werner EF, Ranney ML, Macones GA, Rouse DJ, Savitz DA, Cahill AG. Effect of a Novel Smartphone Application on Breastfeeding Rates Among Low-Income, First-Time Mothers Intending to Exclusively Breastfeed: Secondary Analysis of a Randomized Controlled Trial. Breastfeed Med. 2021 Jan;16(1):59-67. doi: 10.1089/bfm.2020.0240. Epub 2020 Oct 20.