Official Title: “Boosting Breastfeeding in Low-Income, Multi-Ethnic Women: A Primary Care Based RCT”

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 low-income multiethnic women, with stratification for maternal country of birth.

The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions will be tested, compared to a Control standard of care. The intervention and design build upon our prior trial of an LC intervention alone.

PNCs— certified nurse midwives and ob/gyns-- will use a brief, electronically prompted protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will collect infant feeding, and health visit data outside the medical center. Medical center visit data will be obtained from MIS data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months

2. Exclusive Breastfeeding at 1,3, and 6 Months

Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience

3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses

4. To describe participant and provider (LC and PNC) experience of the interventions.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment

Study Primary Completion Date: February 2012

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 that intensity will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.

2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences in the rate of exclusive breastfeeding among the 4 treatment groups. We expect that rates of exclusive breastfeeding will be greatest in the PNC+LC group, followed by the LC, then the PNC, and Control groups, respectively.

Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience

3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses (i.e., otitis media, gastrointestinal, and respiratory infections) by treatment group.

4. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses by intensity of breastfeeding regardless of group assignment.

5. To describe participant and provider (LC and PNC) experience of the interventions.

BINGO is the first RCT in the US of routine provider, primary-care based interventions to increase breastfeeding (BF). Government task forces in the US3 and Canada specifically call for such trials, as well as trials to assess independent effects of combined interventions.

BINGO is the first trial to apply strategies derived from the current National Breastfeeding Awareness Campaign (NBAC). BINGO will employ the NBAC message-- that exclusive BF for 6 months reduces infant ear infections, diarrhea, respiratory illness, and perhaps childhood obesity. We expect this message will yield greater BF intensity, and thus progress toward pending Healthy People 2010 goals for exclusive BF.

BINGO uses evidence-based strategies in practice, consistent with the NIH roadmap. Its interventions are logistically and economically sustainable in clinical practice. They support women pre- and post-natally, across multiple care settings (clinic, hospital, home).

Both Certified Nurse Midwives and Ob/Gyns, deliver the PNC intervention, thus increasing generalizability. BINGO now has the enthusiastic support of perinatal nursing, physician, and lactation specialist groups. This support, at the outset, provides the foundation for effective BINGO interventions to be translated into practice.

Intervention(s) in this Clinical Trial

• Behavioral: Lactation Consultant
  • Lactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum.
• Behavioral: Provider Prompt
  • Prompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise
• Behavioral: LC+ Provider Prompt
  • Participants in this group receive both the LC and Provider Prompt interventions.
• Other: Control
  • Participants in this group do not receive any intervention. They receive the same baseline and post-partum outcomes assessments as those in the Intervention groups.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • LC- Primary-care based lactation consultant meeting women pre- and post-natally.
• Experimental: 2
  • Provider Prompt
• Experimental: 3
  • LC+Provider Prompt
• No Intervention: 4
  • Control standard of care

Primary Measures

• Breastfeeding duration and intensity
  • Time Frame: Assessed at 1,3, and 6 months
    Safety Issue?: No

Secondary Measures

• Infant health visits
  • Time Frame: 12 months
    Safety Issue?: No
• Patient and provider experiences of the interventions
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Albert Einstein College of Medicine of Yeshiva University

Overall Clinical Trial Officials and Contacts

Karen A. Bonuck, PhD Principal Investigator Albert Einstein College of Medicine of Yeshiva University  

Overall Contact: Karen A Bonuck, PhD 718 430 4085 kbonuck@montefiore.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619632

Study ID Number: 2007-031

ClinicalTrials.gov Identifier: NCT00619632

Health Authority: United States: Institutional Review Board