Status:
COMPLETED
Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Montefiore Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Breastfeeding
Breastfeeding, Exclusive
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in lo...
Detailed Description
Primary Outcomes (Hypotheses): Breastfeeding 1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences in breastfeeding intensity among the 4 treatment groups. We expect ...
Eligibility Criteria
Inclusion
- Enrolled/plan to remain in care at the site throughout their pregnancy
- 1st or 2nd trimester (randomization will include trimester as a blocking factor)
- Aged 18 or older
- Can provide a reliable phone number and at least 2 alternative contacts
- Are carrying a singleton pregnancy
- Can communicate in English or Spanish
Exclusion
- High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
- Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
- On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
- Enrolled in site's Group Pre-natal Care (app. 60 women/year)
- Previously enrolled in MILK study
- Craniofacial or neurological conditions that prevent an infant from BF (post-partum exclusion)
- Reported use of street drugs (responds to reviewer comment of how to control for this)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT00619632
Start Date
February 1 2008
End Date
February 1 2013
Last Update
January 14 2015
Active Locations (1)
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1
Comprehensive Family Care Center
The Bronx, New York, United States, 10461