Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

NCT00643253 | Completed Phase 3 DMC

• 2 other identifiers: 2007-490-0001P60MD00516
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

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. 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. 2.Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.
3. 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. 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. 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. 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.

Conditions

Breastfeeding

Keywords

exclusive breastfeeding; breastfeeding promotion; health promotion

Outcome Measures

Primary Outcomes (1)

• Breastfeeding intensity at 1,3, and 6 months

  1,3, and 6 months after birth of the baby

Secondary Outcomes (1)

• Infant growth by treatment group and breastfeeding intensity

  Assessed when baby is 1,3, and 6 months of age

Study Arms (2)

1

EXPERIMENTAL

Receipt of behavioral interventions to encourage breastfeeding.

Behavioral: LC and Electronic Prompt

2

NO INTERVENTION

Standard of Care

Interventions

LC and Electronic Prompt BEHAVIORAL

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.

Also known as: breastfeeding promotion, lactation consultant intervention, electronic health promotion

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weeks pregnant
• receives prenatal care at Centennial women's center of Montefiore Medical Center
• English or Spanish speaking

You may not qualify if:

• pregnant with multiples
• breastfeeding contra-indicated

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (2)

• 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.

  PMID: 24354834 DERIVED

• 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.

  PMID: 22621223 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Karen A. Bonuck, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)