Clinical trial NCT06375655: Texting to Promote Breastfeeding (TOPS)
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Increased Breastfeeding
Keywords: African American
Texting
Breastfeeding
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2024-04-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percentage of participants who do not opt out of receipt of text messages
timeFrame: Up to 6 months postpartum
measure: Percentage of participants who said texts were helpful as measured by questionnaire
timeFrame: Up to 6 months postpartum
measure: Percentage of participants who would refer a friend/family to the texting program
timeFrame: Up to 6 months postpartum
Secondary outcomes:
measure: Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review
timeFrame: Up to 2 months postpartum
measure: Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review
timeFrame: 1 month, 3 months, 6 months postpartum
measure: Percentage of participants who are partially breastfeeding as measured by participant report/chart review
timeFrame: 1 month, 2 months, 3 months, 6 months postpartum
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ahuja Rainbow Center for Women and Children
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lydia Furman, MD
role: PRINCIPAL_INVESTIGATOR
References: