An interventional study of Lactation Consultant and Provider Prompt in Breastfeeding and Breastfeeding, Exclusive, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-14.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Health services research
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
Exclusive Breastfeeding at 1,3, and 6 Months
Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience
Primary Outcomes (Hypotheses): Breastfeeding
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
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.
Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LC- Primary-care based lactation consultant meeting women pre- and post-natally.
Behavioral: Lactation Consultant
Provider Prompt
Behavioral: Provider Prompt
LC+Provider Prompt
Behavioral: LC+ Provider Prompt
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.
Breastfeeding duration and intensity
Time frame: Assessed at 1,3, and 6 months
Infant health visits
Time frame: 12 months
Patient and provider experiences of the interventions
Time frame: 6 months
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Albert Einstein College of Medicine