Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
BINGO
3 other identifiers
interventional
666
1 country
1
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 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
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJanuary 14, 2015
January 1, 2015
5 years
February 4, 2008
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Breastfeeding duration and intensity
Assessed at 1,3, and 6 months
Secondary Outcomes (2)
Infant health visits
12 months
Patient and provider experiences of the interventions
6 months
Study Arms (4)
1
EXPERIMENTALLC- Primary-care based lactation consultant meeting women pre- and post-natally.
2
EXPERIMENTALProvider Prompt
3
EXPERIMENTALLC+Provider Prompt
Control
NO INTERVENTIONInterventions
Lactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum.
Prompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise
Participants in this group receive both the LC and Provider Prompt interventions.
Eligibility Criteria
You may qualify if:
- Enrolled/plan to remain in care at the site throughout their pregnancy
- st 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
You may not qualify if:
- 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
- Reported use of street drugs (responds to reviewer comment of how to control for this)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comprehensive Family Care Center
The Bronx, New York, 10461, United States
Related Publications (2)
Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.
PMID: 24354834DERIVEDAndaya E, Bonuck K, Barnett J, Lischewski-Goel J. Perceptions of primary care-based breastfeeding promotion interventions: qualitative analysis of randomized controlled trial participant interviews. Breastfeed Med. 2012 Dec;7(6):417-22. doi: 10.1089/bfm.2011.0151. Epub 2012 May 23.
PMID: 22621223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen A. Bonuck, PhD
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 21, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 14, 2015
Record last verified: 2015-01