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

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.

Study Overview

• Status: Completed
• Conditions: Increased Breastfeeding
• Intervention / Treatment: Behavioral: Team2BF; Behavioral: Bright By Text

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44103
      • Ahuja Rainbow Center for Women and Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Lydia Furman, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Texting; African American; Breastfeeding
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: STUDY20240085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No