Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers

NCT01272661 | Completed Results DMC

• 1 other identifier: BFS-1
• Study Type: interventional
• Target: 1,296
• Locations: 1 country
• Sites: 1

Brief 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. 1.Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
2. 2.Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
3. 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. 4.What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?

Conditions

Breastfeeding

Keywords

breastfeeding; low-income; high-risk; African-American; health disparity

Outcome Measures

Primary Outcomes (2)

• Program Feasibility- Feeding Outcome Collected

  Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome

  by 24 months

• Program Feasibility - Curriculum Modules

  Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11

  by 24 months from program start

Secondary Outcomes (4)

• Breastfeeding Rate

  Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours

• Breastfeeding Rate at One Month Postpartum

  Any and exclusive breastfeeding at one month, between 21-38 days postpartum

• Breastfeeding Rate at 3 Months Postpartum

  Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum

• Breastfeeding Rate at 6 Months Postpartum

  Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum

Study Arms (3)

Enhanced Curriculum

ACTIVE COMPARATOR

New Enhanced Breastfeeding Curriculum with 11 brief modules

Behavioral: Enhanced Curriculum

Enhanced Curriculum+Breastfeeding Doula

ACTIVE COMPARATOR

Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")

Behavioral: Enhanced Curriculum+Breastfeeding Doula

Enhanced Curriculum +Father Support

ACTIVE COMPARATOR

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

Interventions

Enhanced Curriculum BEHAVIORAL

Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers

Enhanced Curriculum

Enhanced Curriculum+Breastfeeding Doula BEHAVIORAL

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+Breastfeeding Doula

Enhanced Curriculum +Father Support BEHAVIORAL

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.

Enhanced Curriculum +Father Support

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant woman enrolled in MomsFirst Program of Greater Cleveland

You may not qualify if:

• incarceration
• Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• American Academy of Pediatrics: collaborator
• Mt. Sinai Health Care Foundation: collaborator

Study Sites (1)

MomsFirst

Cleveland, Ohio, 44114, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Lydia Furman MD, PI
• Organization: UHospitalsCleveland; Rainbow Babies and CHildren's Hospital

Lydia.Furman@uhhospitals.org

216-844-8260

Study Officials

• Lydia M Furman, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: January 10, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 5, 2015
• Results First Posted: May 28, 2014

Record last verified: 2014-12

Locations

US (1)