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

Not Applicable
Completed
Conditions
Breastfeeding
Interventions
Behavioral: Enhanced Curriculum
Behavioral: Enhanced Curriculum +Father Support
Behavioral: Enhanced Curriculum+Breastfeeding Doula
Registration Number
NCT01272661
Lead Sponsor
University Hospitals Cleveland Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
1296
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced CurriculumEnhanced CurriculumNew Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum +Father SupportEnhanced Curriculum +Father SupportEnhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Breastfeeding DoulaEnhanced Curriculum+Breastfeeding DoulaEnhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")
Primary Outcome Measures
NameTimeMethod
Program Feasibility- Feeding Outcome Collectedby 24 months

Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome

Program Feasibility - Curriculum Modulesby 24 months from program start

Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11

Secondary Outcome Measures
NameTimeMethod
Breastfeeding Rate at One Month PostpartumAny 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.

Breastfeeding Rate at 3 Months PostpartumAny 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.

Breastfeeding RateAny 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.

Breastfeeding Rate at 6 Months PostpartumAny 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.

Trial Locations

Locations (1)

MomsFirst

🇺🇸

Cleveland, Ohio, United States

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