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

Primary Purpose

Breastfeeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BreastFeeding Friend (BFF)
dummy app
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breastfeeding focused on measuring smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Outpatient Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BreastFeeding Friend (BFF)

dummy app

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire

Secondary Outcome Measures

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
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

Full Information

First Posted
May 15, 2017
Last Updated
July 19, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03167073
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding
Keywords
smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BreastFeeding Friend (BFF)
Arm Type
Experimental
Arm 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.
Arm Title
dummy app
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
BreastFeeding Friend (BFF)
Intervention Description
A novel android app designed to improve breastfeeding rates among low-income women
Intervention Type
Other
Intervention Name(s)
dummy app
Intervention Description
A novel android app that looks identical to the intervention app (BFF) but contains limited content.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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.
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
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
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
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
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
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
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
Other Pre-specified Outcome Measures:
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must be pregnant to participate.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam K Lewkowitz, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once unblinded, the investigators may elect to make all de-identified IPD available to other researchers.
Citations:
PubMed Identifier
33826418
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.
Results Reference
derived
PubMed Identifier
33345878
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.
Results Reference
derived
PubMed Identifier
33085510
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.
Results Reference
derived

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

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