Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women

Study Overview
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Brief Summary
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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
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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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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.

Official Title
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Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: BreastFeeding Friend (BFF)
* Other: dummy app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BreastFeeding Friend (BFF)<br>BFF is a novel android app initially created in Microsoft PowerPoint with the results of a well-validated questionnaire administered to the target patient population, in which participants identified barriers preventing them from starting or continuing breastfeeding. The app was then modified by a multidisciplinary team of neonatologists, perinatologists, and certified lactation consultants. The finalized prototype was presented to three focus groups of test users sociodemographically similar to the target population. This approach allowed BFF to be adjusted to maximize the users' experience per their opinions. Once the focus groups' feedback was consistent, the app prototype was provided to a freelance coding team at Washington University of St. Louis, which built a native android app. | Other: BreastFeeding Friend (BFF)<br>* A novel android app designed to improve breastfeeding rates among low-income women<br>|
| Placebo Comparator: dummy app<br>The dummy app looks identical to BFF but is limited to a few pages of information on breastfeeding that is provided in hand-out form during routine prenatal care. | Other: dummy app<br>* A novel android app that looks identical to the intervention app (BFF) but contains limited content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire | Postpartum day number 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum Weight Loss | Postpartum weight loss will be measured by subtracting reported weight at postpartum month 6 obtained from confidential postpartum month 6 survey from measured weight obtained in-person at hospital on postpartum day 2 | 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. | 
| Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire | postpartum week 6 | 
| Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire | postpartum month 3 | 
| Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire | postpartum month 6 | 
| Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | postpartum day 2 | 
| Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | postpartum week 6 | 
| Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | postpartum month 3 | 
| Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | postpartum month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss