Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
NCT ID: NCT00643253
Last Updated: 2013-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
299 participants
INTERVENTIONAL
2008-03-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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1
Receipt of behavioral interventions to encourage breastfeeding.
LC 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.
2
Standard of Care
No interventions assigned to this group
Interventions
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LC 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* receives prenatal care at Centennial women's center of Montefiore Medical Center
* English or Spanish speaking
Exclusion Criteria
* breastfeeding contra-indicated
18 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Karen Bonuck
Professor
Principal Investigators
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Karen A. Bonuck, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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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.
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.
Other Identifiers
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1P60MD00516
Identifier Type: -
Identifier Source: secondary_id
2007-490-000
Identifier Type: -
Identifier Source: org_study_id
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