Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
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
- 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.
- 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
Standard of Care
1
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
Karen Bonuck
Professor
Albert Einstein College of Medicine
