BreastfeedingNCT03167073
Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
A study testing BreastFeeding Friend (BFF) and dummy app in people with Breastfeeding, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- BreastFeeding Friend (BFF) and dummy app
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- multiparous women with contraindications to breastfeeding, multiple gestations, an anomalous fetus, or who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Outpatient Health
St Louis, Missouri, 63108
About this study
Official title: Impact of a Novel 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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- BreastFeeding Friend (BFF), dummy app
- Keywords
- smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss
- Medical subject headings
- Breast Feeding, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastFeeding Friend (BFF)Other
A novel android app designed to improve breastfeeding rates among low-income women
dummy appOther
A novel android app that looks identical to the intervention app (BFF) but contains limited content.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: dummy app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire
Measured: Postpartum day number 2
Secondary outcomes (8)
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
Measured: 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
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum week 6
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire
Measured: postpartum month 3
Number of Participants Breastfeeding Without Formula Supplementation
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum month 6
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum day 2
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum week 6
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum month 3
Number of Participants Breastfeeding With or Without Formula Supplementation
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Measured: postpartum month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start6 Jul 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam K Lewkowitz, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167073
- Sponsor's protocol ID
- 201704147
- Status last verified
- Jul 2021
- First submitted
- 15 May 2017
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once unblinded, the investigators may elect to make all de-identified IPD available to other researchers.
Publications
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.
PubMed 33826418Lewkowitz 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.
PubMed 33345878Lewkowitz 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.
PubMed 33085510
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
- ClinicalTrials.gov ID
- NCT03167073
- Acronym / sponsor ID
- 201704147
- Conditions
- Breastfeeding
- Keywords
- smartphone application, low-income women, breastfeeding, health education, health disparities, postpartum weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BreastFeeding Friend (BFF) | Experimental | Other: 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. |
| dummy app | Placebo comparator | Other: dummy appThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- multiparous women with contraindications to breastfeeding, multiple gestations, an anomalous fetus, or who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastFeeding Friend (BFF)A novel android app designed to improve breastfeeding rates among low-income women | Other | BreastFeeding Friend (BFF) |
| dummy appA novel android app that looks identical to the intervention app (BFF) but contains limited content. | Other | dummy app |
Primary outcome
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
8 secondary outcomes
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.
Number of Participants Breastfeeding Without Formula Supplementation
Time frame: postpartum week 6
Number of Participants Breastfeeding Without Formula Supplementation
Time frame: postpartum month 3
Number of Participants Breastfeeding Without Formula Supplementation
Time frame: postpartum month 6
Number of Participants Breastfeeding With or Without Formula Supplementation
Time frame: postpartum day 2
Number of Participants Breastfeeding With or Without Formula Supplementation
Time frame: postpartum week 6
Number of Participants Breastfeeding With or Without Formula Supplementation
Time frame: postpartum month 3
Number of Participants Breastfeeding With or Without Formula Supplementation
Time frame: postpartum month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33826418Griffin 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.
- Derived from this study: PubMed 33345878Lewkowitz 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.
- Derived from this study: PubMed 33085510Lewkowitz 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.
- Individual participant dataSharing planned: Undecided. Once unblinded, the investigators may elect to make all de-identified IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam K Lewkowitz, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreastFeeding Friend (BFF) and dummy app in people with Breastfeeding, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Breastfeeding Without Formula Supplementation (time frame: Postpartum day number 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167073, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.