We will conduct a randomized, controlled, single-center, single-blind, 2x2 factorial design trial to assess breastfeeding (BF) intensity up to 6 months in low-income multiethnic women, stratifying by foreign birth. Prenatal patients from a large Bronx health center will be randomized into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC+LC, or; (d) Control standard of care. PNCs will use a brief, electronically prompted protocol with women in the PNC and PNC+LC groups throughout pregnancy. Study LCs at the center will conduct individualized pre-natal sessions, hospital and home visits, and phone support with women in the LC and PNC+LC groups. Primary Outcomes: Breastfeeding Differences Among Four Treatment Groups 1) Breastfeeding Intensity at 1,3, and 6 Months- assessed via 7 day recall of breastmilk/other liquid + solids. 2) Exclusive Breastfeeding at 1, 3, and 6 Months- assessed as above. Secondary Outcomes (Descriptive): Infant Health, and Participant & Provider Experiences 3) To describe infant health care use, by treatment group. 4) To describe infant health care use by intensity of BF, regardless of group assignment. 5) To describe participant and provider experience of the interventions. This is the first US trial to assess routine provider, primary-care based BF interventions. Thus, it responds to the US Preventive Services Task Force call for such trials, and, those analyzing the unique and synergistic effects of combined interventions. The National BF Awareness Campaign message-reduced infant illness with 6 months exclusive BF- will be applied. This should yield greater BF intensity, and thus progress towards proposed Healthy People 2010 exclusive BF goals. The design differs from, but builds upon our recent trial of an LC intervention alone. Interviews at 1,3, and 6 months post-partum will assess infant feeding, infant illness, and infant medical visits. Infant's medical center MIS data will be collected. Enthusiastic support (see letters) from perinatal nursing, physician, and lactation specialist groups (American College of Nurse Midwives, American College of Obstetrics & Gynecology, American Academy of Pediatrics, and others) increases the likelihood that effective interventions will be translated into practice. ? ? ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
7R01HD049763-02
Application #
7485354
Study Section
Nursing Science: Children and Families Study Section (NSCF)
Program Officer
Raju, Tonse N
Project Start
2007-07-01
Project End
2012-04-30
Budget Start
2007-09-01
Budget End
2008-04-30
Support Year
2
Fiscal Year
2007
Total Cost
$570,151
Indirect Cost
Name
Albert Einstein College of Medicine
Department
Family Medicine
Type
Schools of Medicine
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
Barnett, Josephine; Aguilar, Stephanie; Brittner, Mindy et al. (2012) Recruiting and retaining low-income, multi-ethnic women into randomized controlled trials: successful strategies and staffing. Contemp Clin Trials 33:925-32
Bonuck, Karen A; Lischewski, Jennifer; Brittner, Mindy (2009) Clinical translational research hits the road: RCT of breastfeeding promotion interventions in routine prenatal care. Contemp Clin Trials 30:419-26
Brittner, Mindy; Lischewski, Jennifer; Bonuck, Karen A (2009) Breastfeeding workshop attracts diverse group of providers. J Hum Lact 25:137-8