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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.
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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreastFeeding Friend (BFF) | Experimental | 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. |
|
| dummy app | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreastFeeding Friend (BFF) | Other | A novel android app designed to improve breastfeeding rates among low-income women |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting That App is Best Breastfeeding Resource | App is best breastfeeding resource, measured by confidential questionnaire | postpartum week 6 |
Inclusion Criteria:
Exclusion Criteria:
Participants must be pregnant to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Adam K Lewkowitz, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Outpatient Health | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33826418 | Derived | 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. | |
| 33345878 | Derived | 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. |
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Once unblinded, the investigators may elect to make all de-identified IPD available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire | Posted | Count of Participants | Participants | Postpartum day number 2 |
|
From enrollment until study completion (7 months per participant). 2 year study dureation.
Same as clinicaltrial.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Lewkowitz | Washington University of St Louis (where research was conducted). Now at Brown University | 401-274-1122 | 47447 | alewkowitz@kentri.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Jul 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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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.
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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.
| dummy app | Other | A novel android app that looks identical to the intervention app (BFF) but contains limited content. |
|
| 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 |
| 33085510 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | 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 | 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. | Posted | 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. |
|
|
| Secondary | Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire | Data were missing from 1 participant in the BFF group. Participants with missing data were excluded from analysis. | Posted | Count of Participants | Participants | postpartum week 6 |
|
|
|
| Secondary | Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire | 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. | Posted | Count of Participants | Participants | postpartum month 3 |
|
|
|
| Secondary | Number of Participants Breastfeeding Without Formula Supplementation | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire | 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. | Posted | Count of Participants | Participants | postpartum month 6 |
|
|
|
| Secondary | Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | Posted | Count of Participants | Participants | postpartum day 2 |
|
|
|
| Secondary | Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | Data were missing from 1 participants in the BFF group. Participants with missing data were excluded from analysis for this outcome. | Posted | Count of Participants | Participants | postpartum week 6 |
|
|
|
| Secondary | Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | 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. | Posted | Count of Participants | Participants | postpartum month 3 |
|
|
|
| Secondary | Number of Participants Breastfeeding With or Without Formula Supplementation | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire | Posted | Count of Participants | Participants | postpartum month 6 |
|
|
|
| Other Pre-specified | Number of Participants Reporting That App is Best Breastfeeding Resource | App is best breastfeeding resource, measured by confidential questionnaire | 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. | Posted | Count of Participants | Participants | postpartum week 6 |
|
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|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | 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. | 0 | 85 | 0 | 85 | 0 | 85 |
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| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |