Provider Approaches to Improved Rates of Infant Nutrition and Growth Study (PAIRINGS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Bonuck, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00643253
First received: March 24, 2008
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.

Condition Intervention Phase
Breastfeeding
Behavioral: LC and Electronic Prompt
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Breastfeeding intensity at 1,3, and 6 months [ Time Frame: 1,3, and 6 months after birth of the baby ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant growth by treatment group and breastfeeding intensity [ Time Frame: Assessed when baby is 1,3, and 6 months of age ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: March 2008
Study Completion Date: July 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receipt of behavioral interventions to encourage breastfeeding.
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.
Other Names:
  • breastfeeding promotion
  • lactation consultant intervention
  • electronic health promotion
No Intervention: 2
Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643253

Locations
United States, New York
Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Karen A. Bonuck, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by Albert Einstein College of Medicine of Yeshiva University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Bonuck, Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00643253     History of Changes
Other Study ID Numbers: 2007-490-000, 1P60MD00516
Study First Received: March 24, 2008
Last Updated: July 9, 2013
Health Authority: United States: National Institutes of Health
United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
exclusive breastfeeding
breastfeeding promotion
health promotion

ClinicalTrials.gov processed this record on August 19, 2014