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

NCT ID: NCT01272661

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-11-30

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. 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?

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Enhanced Curriculum

New Enhanced Breastfeeding Curriculum with 11 brief modules

Group Type: ACTIVE_COMPARATOR

Enhanced Curriculum

Intervention Type: BEHAVIORAL

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

Enhanced Curriculum+Breastfeeding Doula

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

Group Type: ACTIVE_COMPARATOR

Enhanced Curriculum+Breastfeeding Doula

Intervention Type: 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 +Father Support

Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers

Group Type: ACTIVE_COMPARATOR

Enhanced Curriculum +Father Support

Intervention Type: 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.

Interventions

Enhanced Curriculum

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Mt. Sinai Health Care Foundation

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lydia Furman

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lydia M Furman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

MomsFirst

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

BFS-1

Identifier Type: -

Identifier Source: org_study_id