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

NCT03167073 | Completed Results DMC

• 1 other identifier: 201704147
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

smartphone application; low-income women; breastfeeding; health education; health disparities; postpartum weight loss

Outcome Measures

Primary Outcomes (1)

• Number of Participants Breastfeeding Without Formula Supplementation

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

  Postpartum day number 2

Secondary Outcomes (8)

• 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.

• Number of Participants Breastfeeding Without Formula Supplementation

  postpartum week 6

• Number of Participants Breastfeeding Without Formula Supplementation

  postpartum month 3

• Number of Participants Breastfeeding Without Formula Supplementation

  postpartum month 6

• Number of Participants Breastfeeding With or Without Formula Supplementation

  postpartum day 2

Other Outcomes (1)

• Number of Participants Reporting That App is Best Breastfeeding Resource

  postpartum week 6

Study Arms (2)

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.

Other: BreastFeeding Friend (BFF)

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.

Other: dummy app

Interventions

BreastFeeding Friend (BFF) OTHER

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

BreastFeeding Friend (BFF)

dummy app OTHER

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

dummy app

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be pregnant to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• multiparous women with contraindications to breastfeeding, multiple gestations, an anomalous fetus, or who do not speak English

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Center for Outpatient Health

St Louis, Missouri, 63108, United States

Location

Related Publications (3)

• 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.

  PMID: 33826418 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.

  PMID: 33345878 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.

  PMID: 33085510 DERIVED

MeSH Terms

Conditions

Breast Feeding; Health Education

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Dr. Adam Lewkowitz
• Organization: Washington University of St Louis (where research was conducted). Now at Brown University

alewkowitz@kentri.org

401-274-1122

Study Officials

• Adam K Lewkowitz, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 25, 2017
• Study Start: July 6, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-07

Locations

US (1)