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Completed

NCT Number: NCT01272661

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

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?

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MomsFirst

Cleveland, Ohio, 44114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced Curriculum

Behavioral

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

Enhanced Curriculum+Breastfeeding Doula

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

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • American Academy of Pediatrics
  • Mt. Sinai Health Care Foundation

Registry information

Official study title

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

Acronym: BFS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2011
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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