NCT06375655

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

April 16, 2024

Results QC Date

September 5, 2025

Last Update Submit

November 4, 2025

Conditions

Keywords

African AmericanTextingBreastfeeding

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

EXPERIMENTAL

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

Bright By Text

ACTIVE COMPARATOR

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

Interventions

Team2BFBEHAVIORAL

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
Bright By TextBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr. Furman
Organization
University Hospitals Cleveland Medical Center

Study Officials

  • Lydia Furman, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations