Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT (BINGO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Montefiore Medical Center
Information provided by (Responsible Party):
Karen Bonuck, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00619632
First received: February 4, 2008
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.

Condition Intervention
Breastfeeding
Breastfeeding, Exclusive
Behavioral: Lactation Consultant
Behavioral: Provider Prompt
Behavioral: LC+ Provider Prompt
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Breastfeeding duration and intensity [ Time Frame: Assessed at 1,3, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant health visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient and provider experiences of the interventions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 666
Study Start Date: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LC- Primary-care based lactation consultant meeting women pre- and post-natally.
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.
Experimental: 2
Provider Prompt
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
Experimental: 3
LC+Provider Prompt
Behavioral: LC+ Provider Prompt
Participants in this group receive both the LC and Provider Prompt interventions.
No Intervention: 4
Control standard of care
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619632

Locations
United States, New York
Comprehensive Family Care Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
Investigators
Principal Investigator: Karen A. Bonuck, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by Albert Einstein College of Medicine of Yeshiva University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Bonuck, PI, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00619632     History of Changes
Other Study ID Numbers: 06-08-364, NIH R01 HD04976301A2, Montefiore IRB= 06-08-364
Study First Received: February 4, 2008
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014