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OpenTrials
Completed

NCT Number: NCT06375655

Texting to Promote Breastfeeding (TOPS)

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.

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Key information

Conditions

Increased Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahuja Rainbow Center for Women and Children

Cleveland, Ohio, 44103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Team2BF

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Number of Participants Who do Not Opt Out of Receipt of Text Messages

    Time frame: Up to 6 months postpartum

  2. Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire

    Time frame: Up to 6 months postpartum

    Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes.

  3. Number of Participants Who Would Refer a Friend/Family to the Texting Program

    Time frame: Up to 6 months postpartum

    This will be a yes/no answer

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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