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

This study has been completed.
Sponsor:
Collaborators:
Mt. Sinai Health Care Foundation
American Academy of Pediatrics
Information provided by (Responsible Party):
Lydia Furman, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01272661
First received: December 27, 2010
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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?

Condition Intervention
Breastfeeding
Behavioral: Enhanced Curriculum
Behavioral: Enhanced Curriculum+Breastfeeding Doula
Behavioral: Enhanced Curriculum +Father Support

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Program Feasibility- Feeding Outcome Collected [ Time Frame: by 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11


Secondary Outcome Measures:
  • Breastfeeding Rate [ Time Frame: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.


Enrollment: 1296
Study Start Date: June 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272661

Locations
United States, Ohio
MomsFirst
Cleveland, Ohio, United States, 44114
Sponsors and Collaborators
University Hospitals of Cleveland
Mt. Sinai Health Care Foundation
American Academy of Pediatrics
Investigators
Principal Investigator: Lydia M Furman, MD University Hospitals of Cleveland Case Medical Center
  More Information

No publications provided

Responsible Party: Lydia Furman, Associate Professor of Pediatrics, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01272661     History of Changes
Other Study ID Numbers: BFS-1
Study First Received: December 27, 2010
Results First Received: March 25, 2014
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
breastfeeding
low-income
high-risk
African-American
health disparity

ClinicalTrials.gov processed this record on October 01, 2014