Official Title: “Provider Approaches to Improved Rates of Infant Nutrition and Growth Study”

We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.

The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. 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, by treatment group, in the rate of exclusive BF.

Secondary Outcomes (Hypotheses): Infant Growth

3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits.

4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.

5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits

6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: September 2011

Intervention(s) in this Clinical Trial

• Behavioral: LC and Electronic Prompt
  • Women will receive: a) International Board of Certified Lactation Consultant (IBCLC) education/counseling during the pre-natal, intra-partum and post-hospital discharge period to promote early and continued exclusive breastfeeding. The protocol specifies 2 prenatal meetings, a hospital visit, and a home visit if indicated and accepted, and; b) Electronic Medical Record Prompts- will appear on the prenatal record 5 times throughout the pregnancy. They are brief discussion points re breastfeeding that the provider is asked to raise with their patients.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Receipt of behavioral interventions to encourage breastfeeding.
• No Intervention: 2
  • Standard of Care

Primary Measures

• Breastfeeding intensity at 1,3, and 6 months
  • Time Frame: 1,3, and 6 months after birth of the baby
    Safety Issue?: No

Secondary Measures

• Infant growth by treatment group and breastfeeding intensity
  • Time Frame: Assessed when baby is 1,3, and 6 months of age
    Safety Issue?: No

Inclusion Criteria:

• 12-30 weeks pregnant
• receives prenatal care at Centennial women's center of Montefiore Medical Center
• English or Spanish speaking

Exclusion Criteria:

• pregnant with multiples
• breastfeeding contra-indicated

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Albert Einstein College of Medicine of Yeshiva University

Overall Clinical Trial Officials and Contacts

Karen A. Bonuck, PhD Principal Investigator Albert Einstein College of Medicine of Yeshiva University  

Overall Contact: Karen A. Bonuck, PhD 718 430 4085 kbonuck@montefiore.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643253

Study ID Number: 2007-490-000

ClinicalTrials.gov Identifier: NCT00643253

Health Authority: United States: National Institutes of Health