Increased BreastfeedingNCT06375655
Texting to Promote Breastfeeding (TOPS)
A study testing Team2BF and Bright By Text in people with Increased Breastfeeding, run by Case Western Reserve University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Increased Breastfeeding
- What is being tested?
- Team2BF and Bright By Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Committed to feeding formula only to their infant
- No mobile phone with text capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Ahuja Rainbow Center for Women and Children
Cleveland, Ohio, 44103
About this study
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
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.
- Conditions
- Increased Breastfeeding
- Being tested
- Team2BF, Bright By Text
- Keywords
- African American, Texting, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team2BFBehavioural
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 TextBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Bright By Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who do Not Opt Out of Receipt of Text Messages
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 2 months postpartum
Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review
Measured: 1 month, 3 months, 6 months postpartum
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
Measured: 1 month, 2 months, 3 months, 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 Jul 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Increased BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
- Investigators
- Lydia Furman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375655
- Sponsor's protocol ID
- STUDY20240085
- Status last verified
- Nov 2025
- First submitted
- 16 Apr 2024
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06375655
- Acronym / sponsor ID
- STUDY20240085
- Conditions
- Increased Breastfeeding
- Keywords
- African American, Texting, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team2BF | Experimental | Behavioral: Team2BFTeam2BF 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 | Active comparator | Behavioral: Bright By TextBright 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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"
Key exclusion criteria (2 listed)
- Committed to feeding formula only to their infant
- No mobile phone with text capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team2BFTeam2BF 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. | Behavioural | Team2BF |
| Bright By TextBright 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. | Behavioural | Bright By Text |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Increased Breastfeeding
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Effectiveness of Educational Intervention on Sustainable Breastfeeding: The GREEN MOTHER Project
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Avocado Consumption, Nutrients in Human Milk, and Infant Cognitive Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Furman, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team2BF and Bright By Text in people with Increased Breastfeeding, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who do Not Opt Out of Receipt of Text Messages (time frame: Up to 6 months postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.