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OpenTrials
Completed

NCT Number: NCT03167073

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Outpatient Health

St Louis, Missouri, 63108, United States

About this study

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 Unpublished internal data suggest that, while the breastfeeding initiation rate for women receiving prenatal care at Barnes-Jewish Hospital's Medicaid clinic is higher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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BreastFeeding Friend (BFF)

Other

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

dummy app

Other

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

Primary outcomes

  1. Number of Participants Breastfeeding Without Formula Supplementation

    Time frame: Postpartum day number 2

    Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire

Secondary outcomes

  1. Postpartum Weight Loss

    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.

    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

  2. Number of Participants Breastfeeding Without Formula Supplementation

    Time frame: postpartum week 6

    Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire

  3. Number of Participants Breastfeeding Without Formula Supplementation

    Time frame: postpartum month 3

    Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire

  4. Number of Participants Breastfeeding Without Formula Supplementation

    Time frame: postpartum month 6

    Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire

  5. Number of Participants Breastfeeding With or Without Formula Supplementation

    Time frame: postpartum day 2

    Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

  6. Number of Participants Breastfeeding With or Without Formula Supplementation

    Time frame: postpartum week 6

    Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

  7. Number of Participants Breastfeeding With or Without Formula Supplementation

    Time frame: postpartum month 3

    Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

  8. Number of Participants Breastfeeding With or Without Formula Supplementation

    Time frame: postpartum month 6

    Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire

Other outcomes

  1. Number of Participants Reporting That App is Best Breastfeeding Resource

    Time frame: postpartum week 6

    App is best breastfeeding resource, measured by confidential questionnaire

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 25, 2017
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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