Breastfeeding
Conditions
Keywords
exclusive breastfeeding, breastfeeding promotion, health promotion
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.
Interventions
BEHAVIORALLC 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.
Sponsors
National Institutes of Health (NIH)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breastfeeding intensity at 1,3, and 6 months | 1,3, and 6 months after birth of the baby |
Secondary
| Measure | Time frame |
|---|---|
| Infant growth by treatment group and breastfeeding intensity | Assessed when baby is 1,3, and 6 months of age |
Countries
United States
Outcome results
None listed