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NCT02724969 · ClinicalTrials.gov registry record · NA
A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT02724969: Completed NA study, sponsored by University of Pittsburgh.
NCT02724969 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02724969, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study 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
Primary Outcome
Assessed via the H \& H Lactation Scale (21-item Likert scale) Used items 11-20 (the PIBSS (Perceived Infant Breastfeeding Satiety Subscale) and the MIBSS (Maternal-Infant Breastfeeding Satisfaction Subscale); each item score 1-7, with total possible summative score 10-70; higher scores indicative of better outcome (lowered perception of insufficient milk); items 12-15 reverse scored
Interventions
- BEHAVIORAL MILK or Text4Baby text message intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2017-02-10 |
| Est. Completion | 2019-05-13 |
| Phase | NA |
What the finished NCT02724969 record still lists
NCT02724969 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which MILK or Text4Baby text message intervention is the first listed.
NCT02724969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02724969 about?
NCT02724969 is a clinical study titled "A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply". 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 ...
What is the current status of trial NCT02724969?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2017-02-10. Estimated completion is 2019-05-13.
What interventions are being tested in trial NCT02724969?
The interventions under investigation include: MILK or Text4Baby text message intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02724969?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02724969's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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