Breast for Success: A Family-Centered Intervention in Support of

Status Completed

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?

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Breastfeeding

Clinical Trial Details

NCT number	NCT01272661
Study type	Interventional
Source	University Hospital Case Medical Center
Contact
Status	Completed
Phase	N/A
Start date	June 2011
Completion date	November 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms