Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers (BFS)
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|ClinicalTrials.gov Identifier: NCT01272661|
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : May 28, 2014
Last Update Posted : January 5, 2015
Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.
Research Questions to evaluate project feasibility and effectiveness are:
- Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
- Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
- Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
- What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: Enhanced Curriculum Behavioral: Enhanced Curriculum+Breastfeeding Doula Behavioral: Enhanced Curriculum +Father Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Active Comparator: Enhanced Curriculum
New Enhanced Breastfeeding Curriculum with 11 brief modules
Behavioral: Enhanced Curriculum
Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
Active Comparator: Enhanced Curriculum+Breastfeeding Doula
Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Behavioral: 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.
Active Comparator: 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
Behavioral: Enhanced Curriculum +Father Support
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 [ Time Frame: by 24 months ]Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome
- Program Feasibility - Curriculum Modules [ Time Frame: by 24 months from program start ]Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11
- Breastfeeding Rate [ Time Frame: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours ]Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.
- Breastfeeding Rate at One Month Postpartum [ Time Frame: Any and exclusive breastfeeding at one month, between 21-38 days postpartum ]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.
- Breastfeeding Rate at 3 Months Postpartum [ Time Frame: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum ]Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.
- Breastfeeding Rate at 6 Months Postpartum [ Time Frame: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum ]Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272661
|United States, Ohio|
|Cleveland, Ohio, United States, 44114|
|Principal Investigator:||Lydia M Furman, MD||University Hospitals Cleveland Medical Center|