Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Phase 3

Completed

• Conditions: Breastfeeding
• Interventions: Behavioral: LC and Electronic Prompt

• Registration Number: NCT00643253
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-26
• Primary Completion: 2012-09
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 299

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	LC and Electronic Prompt	Receipt of behavioral interventions to encourage breastfeeding.

Primary Outcome Measures

Name	Time	Method
Breastfeeding intensity at 1,3, and 6 months	1,3, and 6 months after birth of the baby

Secondary Outcome Measures

Name	Time	Method
Infant growth by treatment group and breastfeeding intensity	Assessed when baby is 1,3, and 6 months of age

Trial Locations

Locations (1)

Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center; 🇺🇸 Bronx, New York, United States