Trial Outcomes & Findings for Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers (NCT NCT01272661)
NCT ID: NCT01272661
Last Updated: 2015-01-05
Results Overview
Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1296 participants
Primary outcome timeframe
by 24 months
Results posted on
2015-01-05
Participant Flow
Participant milestones
| Measure |
Enhanced Curriculum
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum +Father Support
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Overall Study
STARTED
|
413
|
497
|
386
|
|
Overall Study
COMPLETED
|
287
|
288
|
314
|
|
Overall Study
NOT COMPLETED
|
126
|
209
|
72
|
Reasons for withdrawal
| Measure |
Enhanced Curriculum
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum +Father Support
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Overall Study
lost to followup/case closed/ no birth
|
126
|
209
|
72
|
Baseline Characteristics
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
Baseline characteristics by cohort
| Measure |
Enhanced Curriculum
n=413 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=497 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support
n=386 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
Total
n=1296 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.2 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
23.1 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
413 Participants
n=5 Participants
|
497 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
1296 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
413 participants
n=5 Participants
|
497 participants
n=7 Participants
|
386 participants
n=5 Participants
|
1296 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: by 24 monthsPopulation: Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period
Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome
Outcome measures
| Measure |
Enhanced Curriculum
n=413 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=497 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=386 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Program Feasibility- Feeding Outcome Collected
|
287 participants
|
288 participants
|
314 participants
|
PRIMARY outcome
Timeframe: by 24 months from program startMeasure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11
Outcome measures
| Measure |
Enhanced Curriculum
n=287 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=288 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=314 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Program Feasibility - Curriculum Modules
|
4 modules presented
Interval 1.0 to 7.0
|
3 modules presented
Interval 0.0 to 6.0
|
2 modules presented
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hoursPopulation: ITT analysis was conducted on participants with available data
Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.
Outcome measures
| Measure |
Enhanced Curriculum
n=99 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=122 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=194 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Breastfeeding Rate
|
66 participants
|
98 participants
|
152 participants
|
SECONDARY outcome
Timeframe: Any and exclusive breastfeeding at one month, between 21-38 days postpartumPopulation: ITT analysis conducted on participants with available data
Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.
Outcome measures
| Measure |
Enhanced Curriculum
n=243 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=222 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=259 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Breastfeeding Rate at One Month Postpartum
|
100 participants
|
95 participants
|
134 participants
|
SECONDARY outcome
Timeframe: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartumPopulation: ITT analysis conducted on participants with available data
Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.
Outcome measures
| Measure |
Enhanced Curriculum
n=184 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=189 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=262 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Breastfeeding Rate at 3 Months Postpartum
|
48 participants
|
44 participants
|
67 participants
|
SECONDARY outcome
Timeframe: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartumPopulation: ITT analysis conducted on participants with available data
Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.
Outcome measures
| Measure |
Enhanced Curriculum
n=148 Participants
New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
|
Enhanced Curriculum+Breastfeeding Doula
n=127 Participants
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
|
Enhanced Curriculum+Father Support Program
n=237 Participants
Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
|
|---|---|---|---|
|
Breastfeeding Rate at 6 Months Postpartum
|
22 participants
|
18 participants
|
38 participants
|
Adverse Events
Enhanced Curriculum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Curriculum+Breastfeeding Doula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Curriculum+Father Support Program
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
Lydia Furman MD, PI
UHospitalsCleveland; Rainbow Babies and CHildren's Hospital
Phone: 216-844-8260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place