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Clinical Trials/NCT00643253
NCT00643253CompletedPhase 3

Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Albert Einstein College of Medicine1 site in 1 country299 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
299
Locations
1
Primary Endpoint
Breastfeeding intensity at 1,3, and 6 months

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

2

No Intervention

Standard of Care

1

Experimental

Receipt of behavioral interventions to encourage breastfeeding.

Intervention: LC and Electronic Prompt (Behavioral)

Outcomes

Primary Outcomes

Breastfeeding intensity at 1,3, and 6 months

Time Frame: 1,3, and 6 months after birth of the baby

Secondary Outcomes

  • Infant growth by treatment group and breastfeeding intensity(Assessed when baby is 1,3, and 6 months of age)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen Bonuck

Professor

Albert Einstein College of Medicine

Study Sites (1)

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