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Clinical Trials/NCT06375655
NCT06375655
Completed
N/A

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

Case Western Reserve University1 site in 1 country83 target enrollmentJuly 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Increased Breastfeeding
Sponsor
Case Western Reserve University
Enrollment
83
Locations
1
Primary Endpoint
Number of Participants Who do Not Opt Out of Receipt of Text Messages
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2024
End Date
August 8, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Up to 6 months postpartum

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.

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

  • 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 Sites (1)

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