Texting to Promote Breastfeeding (TOPS)
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
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedResults Posted
Study results publicly available
November 18, 2025
CompletedNovember 18, 2025
November 1, 2025
1.1 years
April 16, 2024
September 5, 2025
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes.
Up to 6 months postpartum
Number of Participants Who Would Refer a Friend/Family to the Texting Program
This will be a yes/no answer
Up to 6 months postpartum
Secondary Outcomes (3)
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
Study Arms (2)
Team2BF
EXPERIMENTALTeam2BF 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.
Bright By Text
ACTIVE COMPARATORBright 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Committed to feeding formula only to their infant
- No mobile phone with text capability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahuja Rainbow Center for Women and Children
Cleveland, Ohio, 44103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Furman
- Organization
- University Hospitals Cleveland Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lydia Furman, MD
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 19, 2024
Study Start
July 15, 2024
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
November 18, 2025
Results First Posted
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share