|
|
|
|
|
|
Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University Montefiore Medical Center National Institute of Child Health and Human Development (NICHD) |
Information provided by: | Albert Einstein College of Medicine of Yeshiva University |
ClinicalTrials.gov Identifier: | NCT00619632 |
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
Condition | Intervention |
Breastfeeding Breastfeeding, Exclusive |
Behavioral: Lactation Consultant Behavioral: Provider Prompt Behavioral: LC+ Provider Prompt Other: Control |
MedlinePlus related topics: | Breast Feeding Prenatal Care |
ChemIDplus related topics: | Phenytoin Phenytoin sodium BaseLine |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment |
Official Title: | Boosting Breastfeeding in Low-Income, Multi-Ethnic Women: A Primary Care Based RCT |
Estimated Enrollment: | 666 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
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.
|
2: Experimental
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
|
3: Experimental
LC+Provider Prompt
|
Behavioral: LC+ Provider Prompt
Participants in this group receive both the LC and Provider Prompt interventions.
|
4: No Intervention
Control standard of care
|
Other: Control
Participants in this group do not receive any intervention. They receive the same baseline and post-partum outcomes assessments as those in the Intervention groups.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen A Bonuck, PhD | 718 430 4085 | kbonuck@montefiore.org |
Contact: Jenny Lischewski, MPH | 718 430 2298 | jlischew@aecom.yu.edu |
United States, New York | |||||
Comprehensive Family Care Center | Recruiting | ||||
Bronx, New York, United States, 10461 | |||||
Principal Investigator: Karen A Bonuck, PhD |
Albert Einstein College of Medicine of Yeshiva University |
Montefiore Medical Center |
National Institute of Child Health and Human Development (NICHD) |
Principal Investigator: | Karen A. Bonuck, PhD | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Department of Family and Social Medicine, Albert Einstein College of Medicine of Yeshiva Univeristy ( Karen Bonuck, PhD ) |
Study ID Numbers: | 2007-031, NIH R01 HD04976301A2, Montefiore IRB= 06-08-364 |
First Received: | February 4, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00619632 |
Health Authority: | United States: Institutional Review Board |
|