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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03167073
Enrollment
170
Registered
2017-05-25
Start date
2017-07-06
Completion date
2019-07-31
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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

OTHERBreastFeeding Friend (BFF)

A novel android app designed to improve breastfeeding rates among low-income women

OTHERdummy app

A novel android app that looks identical to the intervention app (BFF) but contains limited content.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.

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

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Breastfeeding Without Formula SupplementationPostpartum day number 2Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire

Secondary

MeasureTime frameDescription
Postpartum Weight LossParticipants 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 Supplementationpostpartum week 6Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Number of Participants Breastfeeding With or Without Formula Supplementationpostpartum day 2Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

Other

MeasureTime frameDescription
Number of Participants Reporting That App is Best Breastfeeding Resourcepostpartum week 6App is best breastfeeding resource, measured by confidential questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total169

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyStillbirth10

Baseline characteristics

CharacteristicBreastFeeding Friend (BFF)Dummy AppTotal
Age, Categorical
<=18 years
11 Participants8 Participants19 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
73 Participants77 Participants150 Participants
Age, Continuous22.7 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 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
83 Participants83 Participants166 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
71 Participants67 Participants138 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants10 Participants
Race (NIH/OMB)
White
9 Participants10 Participants19 Participants
Region of Enrollment
United States
84 participants85 participants169 participants
Sex: Female, Male
Female
84 Participants85 Participants169 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 840 / 85
other
Total, other adverse events
0 / 840 / 85
serious
Total, serious adverse events
0 / 840 / 85

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding Without Formula Supplementation30 Participants
Dummy AppNumber of Participants Breastfeeding Without Formula Supplementation30 Participants
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

Time frame: postpartum day 2

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding With or Without Formula Supplementation62 Participants
Dummy AppNumber of Participants Breastfeeding With or Without Formula Supplementation66 Participants
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

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding With or Without Formula Supplementation39 Participants
Dummy AppNumber of Participants Breastfeeding With or Without Formula Supplementation49 Participants
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

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding With or Without Formula Supplementation23 Participants
Dummy AppNumber of Participants Breastfeeding With or Without Formula Supplementation28 Participants
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

Time frame: postpartum month 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding With or Without Formula Supplementation10 Participants
Dummy AppNumber of Participants Breastfeeding With or Without Formula Supplementation16 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding Without Formula Supplementation12 Participants
Dummy AppNumber of Participants Breastfeeding Without Formula Supplementation14 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding Without Formula Supplementation10 Participants
Dummy AppNumber of Participants Breastfeeding Without Formula Supplementation10 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Breastfeeding Without Formula Supplementation5 Participants
Dummy AppNumber of Participants Breastfeeding Without Formula Supplementation7 Participants
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

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.

Other Pre-specified

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BreastFeeding Friend (BFF)Number of Participants Reporting That App is Best Breastfeeding Resource34 Participants
Dummy AppNumber of Participants Reporting That App is Best Breastfeeding Resource20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026