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

January 13, 2015 updated by: Karen Bonuck, Albert Einstein College of Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

666

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Comprehensive Family Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding duration and intensity
Time Frame: Assessed at 1,3, and 6 months
Assessed at 1,3, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Infant health visits
Time Frame: 12 months
12 months
Patient and provider experiences of the interventions
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Montefiore Medical Center

Investigators

  • Principal Investigator: Karen A. Bonuck, PhD, Albert Einstein College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 06-08-364
  • NIH R01 HD04976301A2
  • Montefiore IRB= 06-08-364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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