CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,296 enrolled
Drug / intervention
Enhanced Curriculum +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272661
NCT01272661N/ACompleted

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

University Hospitals Cleveland Medical Center·interventional·Posted Jan 10, 2011·Updated Jan 5, 2015

In Brief

A clinical study evaluating Enhanced Curriculum, Enhanced Curriculum+Breastfeeding Doula, and 1 other intervention for Breastfeeding. Completed, enrolled 1,296 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreastfeeding
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.5 years ago

Interventions

Enhanced Curriculumbehavioral

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

Enhanced Curriculum+Breastfeeding Doulabehavioral

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 Supportbehavioral

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.