Trial Outcomes & Findings for Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women (NCT NCT03167073)
NCT ID: NCT03167073
Last Updated: 2021-07-20
Results Overview
Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
Postpartum day number 2
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
COMPLETED
|
84
|
85
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Stillbirth
|
1
|
0
|
Baseline Characteristics
Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women
Baseline characteristics by cohort
| Measure |
BreastFeeding Friend (BFF)
n=84 Participants
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
|
Dummy App
n=85 Participants
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.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
22.7 years
STANDARD_DEVIATION 4.9 • n=93 Participants
|
21.6 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
22.2 years
STANDARD_DEVIATION 4.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=93 Participants
|
85 participants
n=4 Participants
|
169 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Postpartum day number 2Number of participants breastfeeding without formula supplementation. This was obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=84 Participants
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
|
Dummy App
n=85 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding Without Formula Supplementation
|
30 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postpartum week 6Population: Data were missing from 1 participant in the BFF group. Participants with missing data were excluded from analysis.
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=83 Participants
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
|
Dummy App
n=85 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding Without Formula Supplementation
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: postpartum month 3Population: 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.
Number of participants breastfeeding without formula supplementation, to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=76 Participants
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
|
Dummy App
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding Without Formula Supplementation
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: postpartum month 6Population: 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.
Number of participants breastfeeding without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=60 Participants
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
|
Dummy App
n=67 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding Without Formula Supplementation
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: postpartum day 2Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=84 Participants
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
|
Dummy App
n=85 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding With or Without Formula Supplementation
|
62 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: postpartum week 6Population: Data were missing from 1 participants in the BFF group. Participants with missing data were excluded from analysis for this outcome.
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=83 Participants
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
|
Dummy App
n=85 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding With or Without Formula Supplementation
|
39 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: postpartum month 3Population: 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.
Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=76 Participants
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
|
Dummy App
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding With or Without Formula Supplementation
|
23 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: postpartum month 6Number of participants breastfeeding with or without formula supplementation; to be obtained via confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=60 Participants
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
|
Dummy App
n=67 Participants
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.
|
|---|---|---|
|
Number of Participants Breastfeeding With or Without Formula Supplementation
|
10 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: postpartum week 6Population: 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.
App is best breastfeeding resource, measured by confidential questionnaire
Outcome measures
| Measure |
BreastFeeding Friend (BFF)
n=65 Participants
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
|
Dummy App
n=64 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting That App is Best Breastfeeding Resource
|
34 Participants
|
20 Participants
|
Adverse Events
BreastFeeding Friend (BFF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dummy App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Adam Lewkowitz
Washington University of St Louis (where research was conducted). Now at Brown University
Phone: 401-274-1122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place