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N/A N=250 Randomized Double-blind Prevention

A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply

Breast Feeding

Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Perception of Milk Supply — 54.9; 56.2 score on a scale — p=.272

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MILK or Text4Baby text message intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of Pittsburgh
Primary completion
Jan 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Perception of Milk Supply
54.9; 56.2 .272
SECONDARY
Breastfeeding Self-efficacy
51.8; 53.2 .082
SECONDARY
Maternal Anxiety and Depression
5.6; 5.2 .355
SECONDARY
Breastfeeding Continuation
98; 93 .780
SECONDARY
Breastfeeding Exclusivity
61; 63 .588

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).

Eligibility Criteria

Inclusion Criteria

Pregnant women who:

  • are ≥ 18 years;
  • are between 13-25 gestational weeks;
  • have no prior breastfeeding experience or other living biological children;
  • have a personal cell phone with internet access and an unlimited text message plan; and
  • intend to exclusively, or nearly exclusively breastfeed (<2 ounces of artificial milk per day) for at least 2 months postpartum; (6) plan to deliver their infant at MWH.

Exclusion Criteria

  • Maternal, fetal, or neonatal conditions or complications with the potential to physiologically compromise breastfeeding or milk supply (e.g., history of breast reduction surgery, infant cardiac defects, postpartum infant ventilator dependence);
  • current gestation of ≥ 1 fetus;
  • contraindications to breastfeeding as specified by the American Academy of Pediatrics (e.g., HIV+ status).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02724969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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