Clinical trial NCT00619632: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Official title: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-02-21
Enrollment: 666
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

   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.

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 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)

Primary outcomes:
measure: Breastfeeding duration and intensity
timeFrame: Assessed at 1,3, and 6 months
Secondary outcomes:
measure: Infant health visits
timeFrame: 12 months
measure: Patient and provider experiences of the interventions
timeFrame: 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Comprehensive Family Care Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Karen A. Bonuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Andaya 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.