Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lydia Furman, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahuja Rainbow Center for Women and Children | Cleveland | Ohio | 44103 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Enrolled participants were not removed from the study prior to assignment. Three participants delivered prematurely and 3 new participants were recruited in their places to achieve 80 total participants.
Recruitment occurred in person in obstetrical clinics at the Rainbow Ahuja Women and Children's Center from 7/1/24-11/5/24
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Team2BF | 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: 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. |
| FG001 | Bright By Text | 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: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Team2BF | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who do Not Opt Out of Receipt of Text Messages | Posted | Count of Participants | Participants | Up to 6 months postpartum |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Team2BF | 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: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Furman | University Hospitals Cleveland Medical Center | 216-844-3971 | Lydia.Furman@UHhospitals.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2024 | Sep 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2024 | Nov 4, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| BG001 | Bright By Text | 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: 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Not all participants responded | Posted | Count of Participants | Participants | Up to 6 months postpartum |
|
|
|
|
| Primary | Number of Participants Who Would Refer a Friend/Family to the Texting Program | This will be a yes/no answer | All participants did not provide a response | Posted | Count of Participants | Participants | Up to 6 months postpartum |
|
|
|
|
| Secondary | Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review | Missing information from one participant | Posted | Count of Participants | Participants | Up to 2 months postpartum |
|
|
|
|
| Secondary | Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review | None missing at 1 month, 1 missing at 3 and 6 months for Team2BF, 0 missing at 3 months and 2 at 6 months for Bright By Text | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months postpartum |
|
|
|
|
| Secondary | Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review | A different number were analyzed at each time point | Posted | Count of Participants | Participants | 1 month, 2 months, 3 months, 6 months postpartum |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Bright By Text | 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: 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. | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
| 3 months postpartum |
|
|
| 6 months postpartum |
|
|
| 0.3 |
Value at 3 months |
| Odds Ratio (OR) |
| 0.6909776 |
| 2-Sided |
| 95 |
| 0.4025454 |
| 1.1860776 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.3 | Value at 6 months | Odds Ratio (OR) | 0.6909776 | 2-Sided | 95 | 0.4025454 | 1.1860776 | Superiority |
| 2 months postpartum |
|
|
| 3 months postpartum |
|
|
| 6 months postpartum |
|
|
| 0.7 |
Value at 2 months postpartum |
| Odds Ratio (OR) |
| 2.726859 |
| 2-Sided |
| 95 |
| 1.253958 |
| 5.929833 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.3 | Value at 3 months postpartum | Odds Ratio (OR) | 2.726859 | 2-Sided | 95 | 1.253958 | 5.929833 | Superiority |
| Cochran-Mantel-Haenszel | 0.15 | Value at 6 months postpartum | Odds Ratio (OR) | 2.726859 | 2-Sided | 95 | 1.253958 | 5.929833 | Superiority |