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

December 11, 2014 updated by: Lydia Furman, University Hospitals Cleveland Medical Center

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44114
        • MomsFirst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
by 24 months
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
by 24 months from program start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours
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.
Any and exclusive breastfeeding at one month, between 21-38 days postpartum
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.
Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum
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.
Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

American Academy of Pediatrics
Mt. Sinai Health Care Foundation

Investigators

  • Principal Investigator: Lydia M Furman, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 27, 2010

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BFS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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