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

Breastfeeding Clinical Trial

— BFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272661
• Other study ID #: BFS-1
• Status: Completed
• Phase: N/A
• First received: December 27, 2010
• Last updated: December 11, 2014
• Start date: June 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1296
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Enhanced Curriculum
Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
• 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
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.

Locations

Country	Name	City	State
United States	MomsFirst	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	American Academy of Pediatrics, Mt. Sinai Health Care Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Breastfeeding Rate	Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.	Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours	No
Secondary	Breastfeeding Rate at One Month 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.	Any and exclusive breastfeeding at one month, between 21-38 days postpartum	No
Secondary	Breastfeeding Rate at 3 Months Postpartum	Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.	Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum	No
Secondary	Breastfeeding Rate at 6 Months Postpartum	Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.	Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum	No