Increased Breastfeeding
Conditions
Keywords
African American, Texting, Breastfeeding
Brief summary
The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Bright By Text), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC.
Interventions
BEHAVIORALTeam2BF
Team2BF includes 3-4 breastfeeding-supportive messages per time interval, sent weekly from 28 weeks gestation through delivery, daily through 2 weeks postpartum, weekly from 2 to 10 weeks, and then monthly to one year. Other maternal health topics are not addressed.
BEHAVIORALBright By Text
Bright By Text sends 2-4 messages per week from the first trimester through and beyond one year postpartum about a wide range of maternal and child health topics as outlined on their website; 8 messages are specifically about breastfeeding.
Sponsors
University Hospitals Cleveland Medical Center
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Expectant women initiating obstetrical care \<34 weeks or at any prenatal visit up to 34 weeks gestation * Daily access to a mobile phone with text message capabilities, * Self-identify as African-American/Black, * English speaking, and * Infant feeding plan of might or will breastfeed * Receive care at Ahuja Midtown or MAC1200
Exclusion criteria
* Committed to feeding formula only to their infant * No mobile phone with text capability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who do Not Opt Out of Receipt of Text Messages | Up to 6 months postpartum | — |
| Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire | Up to 6 months postpartum | Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes. |
| Number of Participants Who Would Refer a Friend/Family to the Texting Program | Up to 6 months postpartum | This will be a yes/no answer |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review | Up to 2 months postpartum |
| Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 1 month, 3 months, 6 months postpartum |
| Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 1 month, 2 months, 3 months, 6 months postpartum |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in person in obstetrical clinics at the Rainbow Ahuja Women and Children's Center from 7/1/24-11/5/24
Pre-assignment details
Enrolled participants were not removed from the study prior to assignment. Three participants delivered prematurely and 3 new participants were recruited in their places to achieve 80 total participants.
Participants by arm
| Arm | Count |
|---|---|
| Team2BF Team2BF includes 3-4 breastfeeding-supportive messages per time interval, sent weekly from 28 weeks gestation through delivery, daily through 2 weeks postpartum, weekly from 2 to 10 weeks, and then monthly to one year. Other maternal health topics are not addressed.
Team2BF: Team2BF includes 3-4 breastfeeding-supportive messages per time interval, sent weekly from 28 weeks gestation through delivery, daily through 2 weeks postpartum, weekly from 2 to 10 weeks, and then monthly to one year. Other maternal health topics are not addressed. | 40 |
| Bright By Text Bright By Text sends 2-4 messages per week from the first trimester through and beyond one year postpartum about a wide range of maternal and child health topics as outlined on their website; 8 messages are specifically about breastfeeding.
Bright By Text: Bright By Text sends 2-4 messages per week from the first trimester through and beyond one year postpartum about a wide range of maternal and child health topics as outlined on their website; 8 messages are specifically about breastfeeding. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | premature delivery (prior to 35 weeks GA) | 2 | 1 |
Baseline characteristics
| Characteristic | Bright By Text | Total | Team2BF |
|---|---|---|---|
| Age, Continuous | 25.78 Years STANDARD_DEVIATION 5.34 | 26.23 Years STANDARD_DEVIATION 5.43 | 26.68 Years STANDARD_DEVIATION 5.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 40 Participants | 80 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 80 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Participants Who do Not Opt Out of Receipt of Text Messages
Time frame: Up to 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Team2BF | Number of Participants Who do Not Opt Out of Receipt of Text Messages | 40 Participants |
| Bright By Text | Number of Participants Who do Not Opt Out of Receipt of Text Messages | 40 Participants |
p-value: 1Fisher Exact
Primary
Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire
Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes.
Time frame: Up to 6 months postpartum
Population: Not all participants responded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Team2BF | Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire | 22 Participants |
| Bright By Text | Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire | 20 Participants |
Comparison: This analysis did not power the studyp-value: 0.500795% CI: [0.41, 10.25]Fisher Exact
Primary
Number of Participants Who Would Refer a Friend/Family to the Texting Program
This will be a yes/no answer
Time frame: Up to 6 months postpartum
Population: All participants did not provide a response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Team2BF | Number of Participants Who Would Refer a Friend/Family to the Texting Program | 25 Participants |
| Bright By Text | Number of Participants Who Would Refer a Friend/Family to the Texting Program | 22 Participants |
p-value: 0.349795% CI: [0.3986, 232.3218]Fisher Exact
Secondary
Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review
Time frame: 1 month, 3 months, 6 months postpartum
Population: None missing at 1 month, 1 missing at 3 and 6 months for Team2BF, 0 missing at 3 months and 2 at 6 months for Bright By Text
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team2BF | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 1 month postpartum | 18 Participants |
| Team2BF | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 3 months postpartum | 10 Participants |
| Team2BF | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 6 months postpartum | 7 Participants |
| Bright By Text | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 1 month postpartum | 22 Participants |
| Bright By Text | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 3 months postpartum | 15 Participants |
| Bright By Text | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | 6 months postpartum | 11 Participants |
p-value: 0.230295% CI: [0.4025454, 1.1860776]Cochran-Mantel-Haenszel
p-value: 0.395% CI: [0.4025454, 1.1860776]Cochran-Mantel-Haenszel
p-value: 0.395% CI: [0.4025454, 1.1860776]Cochran-Mantel-Haenszel
Secondary
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
Time frame: 1 month, 2 months, 3 months, 6 months postpartum
Population: A different number were analyzed at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team2BF | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 1 month postpartum | 10 Participants |
| Team2BF | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 2 months postpartum | 8 Participants |
| Team2BF | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 3 months postpartum | 7 Participants |
| Team2BF | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 6 months postpartum | 8 Participants |
| Bright By Text | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 6 months postpartum | 4 Participants |
| Bright By Text | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 1 month postpartum | 3 Participants |
| Bright By Text | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 3 months postpartum | 4 Participants |
| Bright By Text | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | 2 months postpartum | 7 Participants |
p-value: 0.0169295% CI: [1.253958, 5.929833]Cochran-Mantel-Haenszel
p-value: 0.795% CI: [1.253958, 5.929833]Cochran-Mantel-Haenszel
p-value: 0.395% CI: [1.253958, 5.929833]Cochran-Mantel-Haenszel
p-value: 0.1595% CI: [1.253958, 5.929833]Cochran-Mantel-Haenszel
Secondary
Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review
Time frame: Up to 2 months postpartum
Population: Missing information from one participant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Team2BF | Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review | 16 Participants |
| Bright By Text | Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review | 18 Participants |
p-value: 0.7Chi-squared