A Proposed Randomized Clinical Trial of the Effectiveness of a New Breastfeeding- Supportive Texting Program Designed Specifically for African-American/Black Expectant Women, as Compared to a National Maternal Health Texting Program, on Rates of Exclusive Breastfeeding at 2 Months
Phase: NA
Conditions: Increased Breastfeeding
Sponsor: Case Western Reserve University

A proposed randomized clinical trial of the effectiveness ofa new breastfeeding- supportive 
texting program designed specifically for African-American/Black expectant women, as 
compared to a national maternal health texting program, on rates of exclusive breastfeeding at 
2months; Short title: TOPS – Texting to Promote Breastfeeding). 
 
NCT06376566 
 
01/19/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT06375655
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Objectives  
Specific Aims  
1. Demonstrate the feasibility and acceptability of a scaled-up program to deliver Team2BF 
text messages to AA/B expectant women considering breastfeeding.  
2. Compare breastfeeding outcomes in the group receiving Team2BF with rates among 
those receiving Bright By Text.  
3. Compare breastfeeding related knowledge and self-efficacy and social support as 
moderators of the relationship between the texting intervention and breastfeeding 
outcomes. (Exploratory aim)  
4. Compare other key health outcomes (appointment attendance and vaccine receipt and 
book reading to infant) between the groups to verify that a focus on breastfeeding 
enhances rather than detracts from general maternal-infant health outcomes. 
(Exploratory aim) 
Study Hypotheses  
1. Participants will find the Team2BF intervention acceptable as measured by >90% 
continuation, by >75% top score helpfulness of messages for breastfeeding and >75% 
endorsement of friend and family referral.  
2. Participants receiving Team2BF will have significantly higher exclusive breastfeeding 
rates at 2 months as compared to participants receiving Bright By Text.  
3. Breastfeeding knowledge, perceived social support for exclusive breastfeeding and self-
efficacy will positively moderate the relationship between texting and breastfeeding 
outcomes, with those in the Team2BF group demonstrating a significantly greater 
increase in these domains with time as compared to the Bright By Text group.  
4. Participants in both groups will have >75% rates of attendance among mothers at the (2-
6 weeks) postpartum obstetrical visit and >75% rates of attendance and vaccine receipt 
for infants at the 2 month (6-12 weeks) well care visit. 
Background  
Exclusive breastfeeding at 6 months is recommended by professional bodies worldwide, 
with profound health benefits for mothers, infants and society, yet achievement continues to be 
an elusive goal with profound national racial inequities persisting. [1-5] Nationally 83.9% of all 
mothers but just 75.5% of African American/Black (AA/B) mothers initiate breastfeeding; with 
respect to the HealthyPeople 2030 goal for 6 months exclusive breastfeeding of 42.4%, 24.9% of 
all mothers but just 19.8% of AA/B mothers are achieving this goal. [6,7] The state of Ohio faces 
similar racial breastfeeding inequities, in that 75,4% of all infants, but just 68.8% of AA/B 
infants, are breastfed at discharge from hospital (2020 data). [8] In specific counties targeted by 

the Ohio Equity Institute (OEI, Ohio Department of Health, Bureau of Maternal Child and Family 
Health) for improvement in birth outcomes, our own Cuyahoga County reports rates of 
continuing breastfeeding at 8 weeks postpartum of 65.8% among AA/B mothers and 73.9% 
among all others. [9] 
These continuing racial inequities in breastfeeding rates create opportunities for new 
ways of supporting and promoting breastfeeding for AA/B mothers. Smart phone technology 
may provide a way to reach and engage AA/B women who otherwise face barriers related to 
racism in accessing resources for breastfeeding. [10] Approximately 83% of AA/Bs, 76% of those 
with income < $30,000 and 95-96% of those ages 18-49 years own a smartphone. [11] There is 
evidence that mobile health (m-health) applications including telephone support, SMS text 
messaging and internet-based support can increase rates of postpartum exclusive 
breastfeeding, however the total number of studies is limited (n=15) with just one focused 
solely on SMS text messaging. [12] With respect to m-health apps, though, most are solely 
informational, few are tailored or personalized [13] and very few are designed specifically for 
AA/B mothers [14]. This gap in m-health products designed with AA/B women’s breastfeeding 
concerns and needs in mind creates another racial inequity; research is needed to overcome 
this barrier. In prior work we elucidated topics and features that AA/B expectant women 
intending to or considering breastfeeding would like to see in a phone app [15], and 
texting/messaging was one specifically endorsed. 
In this research, we follow up on prior work that assessed the feasibility and 
acceptability and content of a culturally-tuned Breastfeeding-supportive Text Messaging Library 
intended for AA/B women. That work (TEAM2BF, STUDY20221270) demonstrated that 
expectant and delivered AA/B women found the text messaging process and content acceptable 
and helpful. None stopped any or all of the messaging, and approximately 6 messages were 
revised as recommended by participants. In this current study we aim to obtain preliminary 
efficacy data by comparing this texting library aimed at promoting breastfeeding to a 
professionally endorsed national maternal child health texting program, Bright By Text, whose 
focus is not breastfeeding. By comparing the TEAM2BF texting program to Bright By Text, we can 
compare whether message content impacts breastfeeding initiation and exclusivity at 2 months. 
The study design is equitable for participants in that both programs use a similar approach 
(texting), both are designed to be accessible to minoritized women of low socioeconomic status, 
and the comparator (Bright By Text) has demonstrated benefits.[16] This study aims to address 
identified gaps in breastfeeding support for AA/B women that we hope can ultimately reduce 
racial inequities in breastfeeding rates. 
 
 

Inclusion and Exclusion Criteria 
 
 
Number of Research Participants  
We will enroll up to 80 participants. Infants are a secondary population and we will enroll up to 
85 infants (85 not 80 to allow for inclusion of multiples if this occurs). 
Recruitment Methods  
Maternal participants will be recruited via OB provider schedules at Ahuja Rainbow Center for 
Women and Children (ARCWC- Midtown location) and MacDonald 1200. Women will be 
approached in person before or after clinic visits with the permission of the OB provider. The 
study may be introduced in a group setting (CenteringPregnancy) but all consent procedures will 
be individual and private. 
Setting  
Expectant women will be recruited at UHCMC locations ARCWC and Mac1200. The intervention 
itself is virtual so following the consent process and enrollment there will not be inperson 
contact (except for the optional interview which can be by telephone or in person as preferred). 

Consent Process  
Potential participants will be recruited as above and approached in person before or after clinic 
visits with the permission of the OB provider. Signed consent will be obtained in person 
following an informed consent procedure with time for questions. The potential participant’s 
exam room is a private place and if this is not available, we will find an unused office or 
conference space to have a private consent process. Potential participants who are interested 
will discuss the research with a study team member using the informed consent document. 
Family or friends may join the discussion if the potential participant chooses, and all questions 
will be answered. The potential participant can decide to participate and sign the informed 
consent or can decide to not join or can think about it further and call the study team if she 
decides to join. 
Sharing of Results with Research Participants 
☒ Results will not be shared with research participants.  
Results are very preliminary and the number of participants is small so to avoid identifiability we 
will not provide results.  
☒ Results will not be shared with research participants’ doctors 
Study Design  
A prospective block-randomized two arm unblinded cohort study. 
Study Procedures 
1- Intervention – study procedures. In summary these include receiving texts, completing 
surveys and interviews, and permitting review of the medical record. 
The study intervention is texting of health information from 28 weeks gestation or from time 
of enrollment (24-34 weeks) through one year postnatally. Participants will be block randomized 
to either Bright By Text or Team2BF. Blocks will be by CenteringPregnancy group for those in this 
program and in sequential blocks of the same number of participants for those in individual 
obstetrical care.  
Those randomized to Bright By Text begin receiving texts as soon as they sign up, and those 
randomized to Team2BF begin receiving texts at 28 weeks or at the time of enrollment if after 
28 weeks.  
Bright By Text sends messages total from the first trimester through eight years postpartum, 
with 2-4 messages per week about a wide range of maternal and child health topics as outlined 
on their website; there are in total 8 messages about breastfeeding from the prenatal period to 
4 months postpartum.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. 
We are not able to collect user interactions with the SMS system (were texts read or not, 
was message link clicked or not) within the TEAM2BF REDCap/Twilio system; Bright By Text does 
have ability to collect user interactions but there is no plan to collect this information for the 
research and no ability for the study team to receive or access it. For TEAM2BF, participants can 
text STOP ALL or STOP SO MANY (to receive only one message per time point [by week 
prenatally or by day postpartum]) and for Bright By Text, participants can text STOP at any time 
to discontinue receiving texts. At the point of any unsubscribe, and at the 6 months postpartum 
time point, the participant will be invited by text to participate in a 10-15 minute interview 
about their experience The interview will be audio recorded and the transcript destroyed once 
call notes are verified against the recording. 
For those who do not respond to the surveys, we will send one automated reminder text, 
and call up to 3 times, to make sure there are not technical difficulties. For those who STOP ALL 
or STOP SO MANY (to receive only one message per time point (by week prenatally or by day 
postpartum), we will ask, “Why unsubscribe?” If the participant does not respond, or does not 
respond to any of the surveys, we will call or email (two tries only) to understand why. 
Mothers can continue to receive monthly messages for months 6-12 postpartum for 
TEAM2BF and up to 8 years postpartum for Bright By Text but this will not be incentivized. 
Mothers will be asked to enter their delivery date; as a backup plan we are requesting to 
check both Delivery Logs (the PI receives these daily weekdays – they include all UHCMC 
MacDonald Women’s deliveries) and the maternal EMR (electronic medical record) to make 
sure we do not miss this date if a mother forgets to enter her delivery date, since a different set 
of text messages is delivered postpartum and the postpartum surveys begin. 
2- Research participants’ safety and comfort will be protected by their ability to text 
“STOP” to end all messaging. Additionally in the informed consent we will have contact 
information for the study team, and the participant can call or email the study team with 
any concerns or questions. 
3- Participants will use their own smartphones for the study. The smartphone is a device 
but it is not being studied. The text messages are being studied. Given the definition of 
software as a medical device (The term “Software as a Medical Device” (SaMD) is 
defined as software intended to be used for one or more medical purposes that perform 
these purposes without being part of a hardware medical device. Reference- 
https://www.fda.gov/medical-devices/digitalhealth-center-excellence/software-medical-

device-samd ), the text messaging does not appear to be SaMD because it is not being 
used to treat, diagnose or manage a condition or disease. 
4- The source records for the study will be the survey data that participants provide and 
the electronic medical record. 
Study Timeline 
 
 
 
Data to be Collected for your study 
Outcome Measures  
Aim #1 - Acceptability  
Receipt of messages measures acceptability because participants can easily end messaging; if at 
least 90% of Team2BF participants continue receipt this will indicate acceptability of the 
intervention. This outcome will be enhanced by asking (a) a single 4 point Likert-scaled question 

about the helpfulness of the texts for breastfeeding and (b) whether the participant would or 
would not refer a friend or family member to Team2BF. 
Aim #2 – Breastfeeding Outcomes  
The main outcome will be exclusive breastfeeding at 2 months because this is a meaningful 
milestone toward the public health goal of 6 months exclusive breastfeeding. We will assess 
partial and exclusive breastfeeding at hospital discharge and at 1, 2, 3 and 6 months post 
delivery using the World Health Organization definitions for exclusive and partial breastfeeding. 
We will also assess timing of discontinuation of breastfeeding if this occurs. 
Aim #3 – Moderators of Breastfeeding Outcomes (Exploratory aim) 
By measuring breastfeeding knowledge at enrollment and again at 2 months we will assess for 
change in knowledge and for relationship to the main breastfeeding outcome. By measuring 
self-efficacy at enrollment and 2 months we will assess for changes in self-efficacy and 
relationship to the main breastfeeding outcome. We will assess perceived social support for 
exclusive breastfeeding at 2 months to compare those who did and did not achieve this goal. 
Aim #4 – Non-breastfeeding Health Outcomes (Exploratory aim) 
We will compare other key health outcomes between the groups that have been documented 
as relevant Bright By Text outcomes, as a direct Bright By Text outcome and a proxy to verify 
that a focus on breastfeeding enhances rather than detracts from general maternal-infant 
health outcomes. Attendance at the maternal postpartum check and attendance at the infant 2, 
4 and 6 months well care appointments, including whether age-appropriate vaccines were 
received, will be assessed, as well as a measure of literacy (number of days per week reading 
books to baby). 
Management of surveys – Generally participants will complete the enrollment timepoint 
surveys electronically, but if their phone is not able to photograph the QR codes that lead to the 
enrollment surveys, these will be administered on paper. The documents will be maintained on 
and transferred on the person of the study team member to the CCHP (Center for Child Health 
Policy) Office MCCO 650. The surveys will be kept in a locked cabinet with study team member 
access only, and after entry into REDCap will be retained until data analysis is complete. 
Data Analysis Plan 
Populations of each group will be compared using descriptive statistics (means and 
ranges, percents and frequencies). The main outcome of breastfeeding exclusively at 2 months 
will be compared between the two arms (texting groups) controlling for factors known to 
impact breastfeeding rates, as well as site of enrollment. 

To calculate sample size both current and near past breastfeeding rates are relevant. At 
the Rainbow Pediatric Practice (RPP, IRB # 11-16-07, using a 3 month annual snapshot) data 
from 2016-2020 inclusive years for full term and late preterm infants not admitted to Neonatal 
Intensive Care Unit who have an appointment in RPP in first month of life: 89/808 infants (11%) 
were exclusively breastfed at 2 months. Women Infants and Children Supplemental Feeding 
Program (WIC) Cuyahoga County data aligns with this estimate, showing “Fully Breastfed 
Infants” (defined as infants of participating breastfeeding women do not receive formula from 
the WIC Program) for the fiscal year 2021 with 594/5188 infants (11.4%) fully breasted. An 
increase from 11% to 14% would be clinically meaningful, and to achieve this with 80% power, 
alpha 0.05 (SD of not more than 5%) we need 36 mother-infant dyads per group, which is 72; 
and allowing for 10% attrition we aim to enroll 40 mothers per group (80 total). 
Without published data on breastfeeding from Bright By Text participants, a 5% point 
difference between the two arms in this outcome can be considered clinically meaningful. The 
timing of breastfeeding cessation is the inverse of partial or exclusive breastfeeding and will be 
compared between the two arms at end of study (6 months); a 1 month difference between the 
groups can be considered clinically meaningful. 
Risks to Research Participants 
There is a risk of breach of confidentiality due to ongoing text messaging but this will be 
protected against by careful management of the texting system by study team members and by 
protecting and securing the data received. There is a risk of emotional distress if a participant’s 
anxiety about breastfeeding is increased by receiving messages about breastfeeding from either 
texting program – this will be mitigated by providing resources through the messages, by the 
ability to unsubscribe promptly, and in the informed consent by emphasizing that this is a 
research study and breastfeeding help can be obtained from her health providers or the Ohio 
Breastfeeding Hotline. There is a risk of data overage or charge depending on what plan a 
participant is on – we cannot mitigate this, but all participants can unsubscribe whenever they 
choose. All participants can text STOP to unsubscribe at any point with either study arm and 
withdraw themselves from the research. 
Provisions to Protect the Privacy Interests of Research Participants 
The privacy of participants will be protected. The consent process will occur in a private space 
or virtually where the potential participant can protect their own privacy. All interventions occur 
virtually on a personal phone, so participants are not exposed to others. 
Potential Benefit to Research Participants 
There are no direct benefits guaranteed to participants. Participants may benefit if the 
TEAM2BF messaging helps them with their breastfeeding and may benefit if Bright By Text 

increases their wellness, but this cannot be guaranteed. We hope the information gained will 
help future women, their families and their health providers with breastfeeding and ultimately 
reduce racial inequities in breastfeeding. 
Withdrawal of Research Participants 
All participants can text STOP to unsubscribe at any point and withdraw themselves from the 
research and from each of the texting programs. A participant would be withdrawn is if there is 
any abuse of the texting system with receipt of inappropriate or profane messages. Mother 
participants who deliver prior to 36 weeks (35 and 6/7 weeks or before) will be exited from the 
study since the postnatal messaging is not tuned for prematurity. 
Alternatives to Participation 
The alternative to participation is simply not to participate. The research is not a substitute for 
clinical care. 
Costs to Research Participants 
There could be a cost for the texting for participants depending on their phone plan. The study 
team cannot be responsible for these costs. 
Research Participant Compensation 
At enrollment, at 1 week postpartum and at 1, 2, 3 and 6 months we will give $25 gift card and a 
tangible gift (diapers+wipes or onesies). 
Provisions to Monitor the Data to Ensure the Safety of Research Participants 
The PI and research coordinator will meet at least every other week to review for adherence to 
protocol, trouble shooting, and any events. We will not convene a DSMB. 
Drugs or Devices 
Participants will use their own smartphones for the study. The smartphone is a device but it is 
not being studied. The text messages are being studied. Given the definition of software as a 
medical device (The term “Software as a Medical Device” (SaMD) is defined as software 
intended to be used for one or more medical purposes that perform these purposes without 
being part of a hardware medical device. Reference- https://www.fda.gov/medical-
devices/digitalhealth-center-excellence/software-medical-device-samd ), the text messaging 
does not appear to be SaMD because it is not being used to treat, diagnose, cure, mitigate or 
manage a condition or disease. There are no drugs involved in this study. 
 

Additional Information  
The program that is used for the TEAM2BF texting is currently Twilio via REDCap. Twilio, a third-
party web service, allows SMS text messages to be sent via REDCap Links within the messages 
go to free content – most content is publicly available, and for those PDFs that are not publicly 
available, we have used a REDCap function called “Dashboard” that permits us to create an URL 
for each of the PDFs. Bright By Text (https://brightbytext.org/ ) is commercially available– when 
signing up, participants provide due date, zip code, language preference (English or Spanish) 
and phone number to the site. Research surveys will be sent from REDCap for all participants. 
Regarding the study title: The CTSC funding submission long title, “A proposed randomized 
clinical trial of the effectiveness of a new breastfeeding-supportive texting program designed 
specifically for African-American/Black expectant women, as compared to a national maternal 
health texting program, on rates of exclusive breastfeeding at 2 months” has been added to 
both the Protocol and the Supplemental form. Due to the complexity and length of the formal 
title, we are requesting to retain the shorter title, “TOPS – Texting to Promote Breastfeeding,” as 
the header in the informed consent. The reason for this request is that the population of 
interest may have low health literacy and may have negative perceptions of very academic 
descriptors; the study is the same and is described equally by both the short and long titles. 
Community-Based Participatory Research – NA 
International information – NA 
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