Breastfeeding
Conditions
Keywords
smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss
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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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.
Interventions
A novel android app designed to improve breastfeeding rates among low-income women
A novel android app that looks identical to the intervention app (BFF) but contains limited content.
Sponsors
Study design
Masking description
The coding team has labeled BFF and the dummy app as BFF-1 and BFF-2. The research team is blinded to which app is BFF-1 and which is BFF-2. Sprint Telecommunications will receive the .apks files for both apps and load one app to each research phone according to the randomization algorithm that researchers at Washington University will provide to them. This algorithm has been created to randomize participants in blocks of four. Sprint will then send the phones to the research team with labels on the box that state the research phone number and app number (ie, phone 18, BFF-2). Participants will be given the phones in a sequential manner. After the study is completed, the researchers will contact the coding team, and the study will be un-blinded.
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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Breastfeeding Without Formula Supplementation | Postpartum day number 2 | Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Weight Loss | 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. | 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 |
| Number of Participants Breastfeeding Without Formula Supplementation | postpartum week 6 | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire |
| Number of Participants Breastfeeding With or Without Formula Supplementation | postpartum day 2 | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting That App is Best Breastfeeding Resource | postpartum week 6 | App is best breastfeeding resource, measured by confidential questionnaire |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BreastFeeding Friend (BFF) 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.
BreastFeeding Friend (BFF): A novel android app designed to improve breastfeeding rates among low-income women | 84 |
| Dummy App 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.
dummy app: A novel android app that looks identical to the intervention app (BFF) but contains limited content. | 85 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Stillbirth | 1 | 0 |
Baseline characteristics
| Characteristic | BreastFeeding Friend (BFF) | Dummy App | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 77 Participants | 150 Participants |
| Age, Continuous | 22.7 years STANDARD_DEVIATION 4.9 | 21.6 years STANDARD_DEVIATION 4 | 22.2 years STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 83 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 67 Participants | 138 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United States | 84 participants | 85 participants | 169 participants |
| Sex: Female, Male Female | 84 Participants | 85 Participants | 169 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 85 |
| other Total, other adverse events | 0 / 84 | 0 / 85 |
| serious Total, serious adverse events | 0 / 84 | 0 / 85 |
Outcome results
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire
Time frame: Postpartum day number 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding Without Formula Supplementation | 30 Participants |
| Dummy App | Number of Participants Breastfeeding Without Formula Supplementation | 30 Participants |
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding With or Without Formula Supplementation | 62 Participants |
| Dummy App | Number of Participants Breastfeeding With or Without Formula Supplementation | 66 Participants |
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum week 6
Population: Data were missing from 1 participants in the BFF group. Participants with missing data were excluded from analysis for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding With or Without Formula Supplementation | 39 Participants |
| Dummy App | Number of Participants Breastfeeding With or Without Formula Supplementation | 49 Participants |
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum month 3
Population: Data were missing from 8 participants in the BFF group and 9 participants in the dummy app group. Participants with missing data were excluded from analysis for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding With or Without Formula Supplementation | 23 Participants |
| Dummy App | Number of Participants Breastfeeding With or Without Formula Supplementation | 28 Participants |
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding With or Without Formula Supplementation | 10 Participants |
| Dummy App | Number of Participants Breastfeeding With or Without Formula Supplementation | 16 Participants |
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum week 6
Population: Data were missing from 1 participant in the BFF group. Participants with missing data were excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding Without Formula Supplementation | 12 Participants |
| Dummy App | Number of Participants Breastfeeding Without Formula Supplementation | 14 Participants |
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire
Time frame: postpartum month 3
Population: Data were missing from 8 participants in the BFF group and 9 participants in the dummy app group. Participants with missing data were excluded from analysis for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding Without Formula Supplementation | 10 Participants |
| Dummy App | Number of Participants Breastfeeding Without Formula Supplementation | 10 Participants |
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Time frame: postpartum month 6
Population: Data were missing from 24 participants in the BFF group and 18 participants in the dummy app group. Participants with missing data were excluded from analysis for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Breastfeeding Without Formula Supplementation | 5 Participants |
| Dummy App | Number of Participants Breastfeeding Without Formula Supplementation | 7 Participants |
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
Time frame: 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.
Population: Data were not collected for this outcome because owning a home scale was not a requirement for study eligibility, and women in our study population did not own scales at home so were unable to provide weights at 6 months postpartum.
Number of Participants Reporting That App is Best Breastfeeding Resource
App is best breastfeeding resource, measured by confidential questionnaire
Time frame: postpartum week 6
Population: Data were missing from 19 participants in the BFF group and 21 participants in the dummy app group. Participants with missing data were excluded from analysis for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BreastFeeding Friend (BFF) | Number of Participants Reporting That App is Best Breastfeeding Resource | 34 Participants |
| Dummy App | Number of Participants Reporting That App is Best Breastfeeding Resource | 20 Participants |