Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03167073
Collaborator
(none)
170
1
2
24.8
6.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Primary Purpose:
Other
Official Title:
Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Actual Study Start Date
:
Jul 6, 2017
Actual Primary Completion Date
:
Jul 31, 2019
Actual Study Completion Date
:
Jul 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: BreastFeeding Friend (BFF)
A novel android app designed to improve breastfeeding rates among low-income women
|
| Placebo Comparator: 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. |
Other: dummy app
A novel android app that looks identical to the intervention app (BFF) but contains limited content.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Without Formula Supplementation [postpartum month 3]
Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire
- Number of Participants Breastfeeding Without Formula Supplementation [postpartum month 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
- Number of Participants Breastfeeding With or Without Formula Supplementation [postpartum week 6]
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
- Number of Participants Breastfeeding With or Without Formula Supplementation [postpartum month 3]
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
- Number of Participants Breastfeeding With or Without Formula Supplementation [postpartum month 6]
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Other Outcome Measures
- Number of Participants Reporting That App is Best Breastfeeding Resource [postpartum week 6]
App is best breastfeeding resource, measured by confidential questionnaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Outpatient Health | Saint Louis | Missouri | United States | 63108 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Adam K Lewkowitz, MD, Washington University School of Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03167073
Other Study ID Numbers:
- 201704147
First Posted:
May 25, 2017
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Period Title: Overall Study | ||
| STARTED | 85 | 85 |
| COMPLETED | 84 | 85 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | Total of all reporting groups |
| Overall Participants | 84 | 85 | 169 |
| Age (Count of Participants) | |||
| <=18 years |
11
13.1%
|
8
9.4%
|
19
11.2%
|
| Between 18 and 65 years |
73
86.9%
|
77
90.6%
|
150
88.8%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
22.7
(4.9)
|
21.6
(4.0)
|
22.2
(4.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
84
100%
|
85
100%
|
169
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
1.2%
|
2
2.4%
|
3
1.8%
|
| Not Hispanic or Latino |
83
98.8%
|
83
97.6%
|
166
98.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
2
2.4%
|
2
1.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
71
84.5%
|
67
78.8%
|
138
81.7%
|
| White |
9
10.7%
|
10
11.8%
|
19
11.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
4
4.8%
|
6
7.1%
|
10
5.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
84
100%
|
85
100%
|
169
100%
|
Outcome Measures
| Title | Number of Participants Breastfeeding Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire |
| Time Frame | Postpartum day number 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 84 | 85 |
| Count of Participants [Participants] |
30
35.7%
|
30
35.3%
|
| Title | Postpartum Weight Loss |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants Breastfeeding Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were missing from 1 participant in the BFF group. Participants with missing data were excluded from analysis. |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 83 | 85 |
| Count of Participants [Participants] |
12
14.3%
|
14
16.5%
|
| Title | Number of Participants Breastfeeding Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire |
| Time Frame | postpartum month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 76 | 76 |
| Count of Participants [Participants] |
10
11.9%
|
10
11.8%
|
| Title | Number of Participants Breastfeeding Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 60 | 67 |
| Count of Participants [Participants] |
5
6%
|
7
8.2%
|
| Title | Number of Participants Breastfeeding With or Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 84 | 85 |
| Count of Participants [Participants] |
62
73.8%
|
66
77.6%
|
| Title | Number of Participants Breastfeeding With or Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were missing from 1 participants in the BFF group. Participants with missing data were excluded from analysis for this outcome. |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 83 | 85 |
| Count of Participants [Participants] |
39
46.4%
|
49
57.6%
|
| Title | Number of Participants Breastfeeding With or Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 76 | 76 |
| Count of Participants [Participants] |
23
27.4%
|
28
32.9%
|
| Title | Number of Participants Breastfeeding With or Without Formula Supplementation |
|---|---|
| Description | Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire |
| Time Frame | postpartum month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 60 | 67 |
| Count of Participants [Participants] |
10
11.9%
|
16
18.8%
|
| Title | Number of Participants Reporting That App is Best Breastfeeding Resource |
|---|---|
| Description | App is best breastfeeding resource, measured by confidential questionnaire |
| Time Frame | postpartum week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | BreastFeeding Friend (BFF) | Dummy App |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 65 | 64 |
| Count of Participants [Participants] |
34
40.5%
|
20
23.5%
|
Adverse Events
| Time Frame | From enrollment until study completion (7 months per participant). 2 year study dureation. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Same as clinicaltrial.gov definitions | |||
| Arm/Group Title | BreastFeeding Friend (BFF) | Dummy App | ||
| Arm/Group Description | 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 | 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. | ||
All Cause Mortality |
||||
| BreastFeeding Friend (BFF) | Dummy App | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | 0/85 (0%) | ||
Serious Adverse Events |
||||
| BreastFeeding Friend (BFF) | Dummy App | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | 0/85 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| BreastFeeding Friend (BFF) | Dummy App | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | 0/85 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Adam Lewkowitz |
|---|---|
| Organization | Washington University of St Louis (where research was conducted). Now at Brown University |
| Phone | 401-274-1122 ext 47447 |
| alewkowitz@kentri.org |
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03167073
Other Study ID Numbers:
- 201704147
First Posted:
May 25, 2017
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021