Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
Brief Summary: The purpose of this pilot randomized trial is to determine the effectiveness, feasibility, and acceptability of a mobile, semi-automated text message-based intervention (MILK) to prevent perceived low or insufficient milk supply (PIM) among mothers without prior breastfeeding experience. PIM is the leading cause of premature breastfeeding cessation, and prior work shows that it is often rooted in low breastfeeding self-efficacy and misconceptions about lactation physiology and trajectory. The MILK intervention is designed to address PIM, as well as other common breastfeeding problems via semi-automated text messages of prenatal and postpartum breastfeeding education and support. Messages are time-sensitive (e.g., specific to gestational age, time since delivery) and based on the Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled from pilot work that investigated how first-time mothers view, manage and describe breastfeeding problems. Messages were vetted with clinical lactation experts, as well as pregnant and postpartum women with no other children.

The MILK intervention will be trialed against a control intervention group, who will receive general perinatal education through the national Text4Baby system. The investigators will recruit approximately 186 healthy, pregnant women at 13-25 weeks gestation from Magee Women's Hospital clinics and outpatient sites. Women will be randomized via computer-generated simple randomization to the experimental or control intervention. Both groups will receive text messages 3-5 times per week from week 25 of pregnancy through week 8 postpartum. Measured outcomes of interest will include perceived breast milk supply, breastfeeding confidence, maternal anxiety, breastfeeding exclusivity, and breastfeeding duration. Data will be collected at baseline (13-25 gestational weeks), 34-36 gestational weeks, and at 1, 2, 4, and 8 weeks postpartum via online survey or telephone call. To assess the potential longer-term impact of the intervention, breastfeeding continuation and exclusivity will be reassessed via telephone at 6 months postpartum. Between group and group x time differences in outcome measures will be examined graphically and via linear mixed modeling. To inform modifications to MILK, telephone interviews will be conducted with a subset of participants in each group to assess and compare intervention use, burdens and challenges, and suggested alterations (8 weeks).


Options:
A: Arm Label: Home-based counselling visits by volunteers; Type: EXPERIMENTAL; Interventions: Behavioral: Home-based counselling | Arm Label: Standard care through existing health system; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Home-based counselling; Assigned to Arm(s): Home-based counselling visits by volunteers
B: Arm Label: Lactation Consultant; Type: ACTIVE_COMPARATOR; Interventions: Other: Lactation Consultant support | Arm Label: current treatment for jaundice; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Lactation Consultant support; Assigned to Arm(s): Lactation Consultant
C: Arm Label: MILK intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: MILK or Text4Baby text message intervention | Arm Label: Text4Baby control intervention group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: MILK or Text4Baby text message intervention | Intervention Type: BEHAVIORAL; Name: MILK or Text4Baby text message intervention; Assigned to Arm(s): MILK intervention group, Text4Baby control intervention group
D: Arm Label: Standard well child care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Food Activity Breast feeding support; Type: EXPERIMENTAL; Interventions: Behavioral: FAB | Arm Label: Sleep; Type: EXPERIMENTAL; Interventions: Behavioral: Sleep | Arm Label: FAB + Sleep; Type: EXPERIMENTAL; Interventions: Behavioral: FAB, Behavioral: Sleep | Intervention Type: BEHAVIORAL; Name: FAB; Assigned to Arm(s): FAB + Sleep, Food Activity Breast feeding support | Intervention Type: BEHAVIORAL; Name: Sleep; Assigned to Arm(s): FAB + Sleep, Sleep

Answer: C