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

Breastfeeding Clinical Trial

— BINGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619632
• Other study ID #: 06-08-364
• Secondary ID: NIH R01 HD049763
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: January 13, 2015
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: January 2015
• Source: Albert Einstein College of Medicine of Yeshiva University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive

Intervention

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.
• 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
• LC+ Provider Prompt
Participants in this group receive both the LC and Provider Prompt interventions.

Locations

Country	Name	City	State
United States	Comprehensive Family Care Center	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine of Yeshiva University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding duration and intensity		Assessed at 1,3, and 6 months	No
Secondary	Infant health visits		12 months	No
Secondary	Patient and provider experiences of the interventions		6 months	No