Trial Outcomes & Findings for Texting to Promote Breastfeeding (TOPS) (NCT NCT06375655)
NCT ID: NCT06375655
Last Updated: 2025-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Up to 6 months postpartum
Results posted on
2025-11-18
Participant Flow
Recruitment occurred in person in obstetrical clinics at the Rainbow Ahuja Women and Children's Center from 7/1/24-11/5/24
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
premature delivery (prior to 35 weeks GA)
|
2
|
1
|
Baseline Characteristics
Texting to Promote Breastfeeding (TOPS)
Baseline characteristics by cohort
| Measure |
Team2BF
n=40 Participants
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.
|
Bright By Text
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=202 Participants
|
40 Participants
n=283 Participants
|
80 Participants
n=120 Participants
|
|
Age, Continuous
|
26.68 Years
STANDARD_DEVIATION 5.55 • n=202 Participants
|
25.78 Years
STANDARD_DEVIATION 5.34 • n=283 Participants
|
26.23 Years
STANDARD_DEVIATION 5.43 • n=120 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=202 Participants
|
40 Participants
n=283 Participants
|
80 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=202 Participants
|
40 Participants
n=283 Participants
|
80 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months postpartumOutcome measures
| Measure |
Team2BF
n=40 Participants
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.
|
Bright By Text
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants Who do Not Opt Out of Receipt of Text Messages
|
40 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months postpartumPopulation: Not all participants responded
Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes.
Outcome measures
| Measure |
Team2BF
n=26 Participants
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.
|
Bright By Text
n=27 Participants
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.
|
|---|---|---|
|
Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire
|
22 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months postpartumPopulation: All participants did not provide a response
This will be a yes/no answer
Outcome measures
| Measure |
Team2BF
n=26 Participants
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.
|
Bright By Text
n=26 Participants
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.
|
|---|---|---|
|
Number of Participants Who Would Refer a Friend/Family to the Texting Program
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 2 months postpartumPopulation: Missing information from one participant
Outcome measures
| Measure |
Team2BF
n=39 Participants
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.
|
Bright By Text
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months postpartumPopulation: 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
Outcome measures
| Measure |
Team2BF
n=40 Participants
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.
|
Bright By Text
n=40 Participants
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.
|
|---|---|---|
|
Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review
1 month postpartum
|
18 Participants
|
22 Participants
|
|
Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review
3 months postpartum
|
10 Participants
|
15 Participants
|
|
Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review
6 months postpartum
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 month, 2 months, 3 months, 6 months postpartumPopulation: A different number were analyzed at each time point
Outcome measures
| Measure |
Team2BF
n=35 Participants
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.
|
Bright By Text
n=37 Participants
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.
|
|---|---|---|
|
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
1 month postpartum
|
10 Participants
|
3 Participants
|
|
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
2 months postpartum
|
8 Participants
|
7 Participants
|
|
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
3 months postpartum
|
7 Participants
|
4 Participants
|
|
Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review
6 months postpartum
|
8 Participants
|
4 Participants
|
Adverse Events
Team2BF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bright By Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Furman
University Hospitals Cleveland Medical Center
Phone: 216-844-3971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place