Clinical trial NCT00643253: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
Official title: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breastfeeding
Keywords: exclusive breastfeeding
breastfeeding promotion
health promotion
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-03-26
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Breastfeeding intensity at 1,3, and 6 months
timeFrame: 1,3, and 6 months after birth of the baby
Secondary outcomes:
measure: Infant growth by treatment group and breastfeeding intensity
timeFrame: Assessed when baby is 1,3, and 6 months of age
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Karen A. Bonuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.
citation: Andaya E, Bonuck K, Barnett J, Lischewski-Goel J. Perceptions of primary care-based breastfeeding promotion interventions: qualitative analysis of randomized controlled trial participant interviews. Breastfeed Med. 2012 Dec;7(6):417-22. doi: 10.1089/bfm.2011.0151. Epub 2012 May 23.