Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Study Overview
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Brief Summary
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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 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. 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 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. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age. 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 Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.

Official Title
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Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: LC and Electronic Prompt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receipt of behavioral interventions to encourage breastfeeding. | Behavioral: LC and Electronic Prompt<br>* 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.<br>* Other names: electronic health promotion;|
| No Intervention: 2<br>Standard of Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding intensity at 1,3, and 6 months |  | 1,3, and 6 months after birth of the baby | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant growth by treatment group and breastfeeding intensity |  | Assessed when baby is 1,3, and 6 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exclusive breastfeeding, breastfeeding promotion, health promotion