Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
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.


Options:
A: Arm Label: Breast feeding optimization; Type: EXPERIMENTAL; Interventions: Behavioral: Breast feeding optimization, Behavioral: Usual care | Arm Label: Usual/routine care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual care | Intervention Type: BEHAVIORAL; Name: Breast feeding optimization; Assigned to Arm(s): Breast feeding optimization | Intervention Type: BEHAVIORAL; Name: Usual care; Assigned to Arm(s): Breast feeding optimization, Usual/routine care
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Low Intensity; Type: OTHER; Interventions: Other: Telephone-based breastfeeding peer counseling | Arm Label: High Intensity; Type: ACTIVE_COMPARATOR; Interventions: Other: Telephone-based breastfeeding peer counseling | Intervention Type: OTHER; Name: Telephone-based breastfeeding peer counseling; Assigned to Arm(s): High Intensity, Low Intensity
C: Arm Label: Breastfeeding promotion intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Breastfeeding promotion intervention | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Breastfeeding promotion intervention; Assigned to Arm(s): Breastfeeding promotion intervention
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: LC and Electronic Prompt | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: LC and Electronic Prompt; Assigned to Arm(s): 1

Answer: D