Clinical trial NCT01272661: Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
Official title: Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding
low-income
high-risk
African-American
health disparity
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Mt. Sinai Health Care Foundation
First posted: 2011-01-10
Enrollment: 1296
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Program Feasibility- Feeding Outcome Collected
timeFrame: by 24 months
measure: Program Feasibility - Curriculum Modules
timeFrame: by 24 months from program start
Secondary outcomes:
measure: Breastfeeding Rate
timeFrame: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours
measure: Breastfeeding Rate at One Month Postpartum
timeFrame: Any and exclusive breastfeeding at one month, between 21-38 days postpartum
measure: Breastfeeding Rate at 3 Months Postpartum
timeFrame: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum
measure: Breastfeeding Rate at 6 Months Postpartum
timeFrame: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MomsFirst
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lydia M Furman, MD
role: PRINCIPAL_INVESTIGATOR
References: