N/A
N=1,296
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT01272661 ↗Enrolled (actual)
1,296
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Program Feasibility- Feeding Outcome Collected — 287; 288; 314 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Curriculum (Behavioral); Enhanced Curriculum+Breastfeeding Doula (Behavioral); Enhanced Curriculum +Father Support (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Feasibility- Feeding Outcome Collected |
287; 288; 314 | — |
| PRIMARY Program Feasibility - Curriculum Modules |
4; 3; 2 | — |
| SECONDARY Breastfeeding Rate |
66; 98; 152 | — |
| SECONDARY Breastfeeding Rate at One Month Postpartum |
100; 95; 134 | — |
| SECONDARY Breastfeeding Rate at 3 Months Postpartum |
48; 44; 67 | — |
| SECONDARY Breastfeeding Rate at 6 Months Postpartum |
22; 18; 38 | — |
Summary
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:
1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
Eligibility Criteria
Inclusion Criteria
- pregnant woman enrolled in MomsFirst Program of Greater Cleveland
Exclusion Criteria
- incarceration
Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.
Data sourced from ClinicalTrials.gov (NCT01272661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.