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

NCT02724969 | Completed Results

• 2 other identifiers: PRO160200075R00NR015106
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Feeding

Keywords

text messaging; short message service

Outcome Measures

Primary Outcomes (1)

• Perception of Milk Supply

  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

  8 weeks postpartum

Secondary Outcomes (4)

• Breastfeeding Self-efficacy

  8 weeks postpartum

• Maternal Anxiety and Depression

  8 weeks postpartum

• Breastfeeding Continuation

  8 weeks postpartum

• Breastfeeding Exclusivity

  8 weeks postpartum

Study Arms (2)

MILK intervention group

EXPERIMENTAL

Semi-automated text messages sent to participants' cellular phones 3-5 times per week beginning Week 25 of pregnancy, through 8 weeks postpartum, specific to breastfeeding support and prevention of perceived insufficient milk supply.

Behavioral: MILK or Text4Baby text message intervention

Text4Baby control intervention group

ACTIVE COMPARATOR

Text4Baby automated texts sent to participants' cellular phones 3-5 times per week from Week 25 of pregnancy through the postpartum period from the national Text4Baby system. Messages provide general prenatal and postpartum support, including breastfeeding.

Behavioral: MILK or Text4Baby text message intervention

Interventions

MILK or Text4Baby text message intervention BEHAVIORAL

MILK text message intervention encompasses prenatal and postpartum breastfeeding support and education text messages. Text4Baby text message intervention encompasses prenatal and postpartum text messages about pregnancy, infant care, and postpartum issues.

MILK intervention group; Text4Baby control intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• Demirci JR, Suffoletto B, Doman J, Glasser M, Chang JC, Sereika SM, Bogen DL. The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 29;8(4):e17328. doi: 10.2196/17328.

  PMID: 32347815 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Milk

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Results Point of Contact

• Title: Jill R. Demirci, PhD, RN, IBCLC
• Organization: University of Pittsburgh

jvr5@pitt.edu

412-648-9236

Study Officials

• Jill Demirci, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Lactation consultant providing assistance has no knowledge of group assignment. Statistician completing final analysis of data will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: March 31, 2016
• Study Start: February 10, 2017
• Primary Completion: January 4, 2019
• Study Completion: May 13, 2019
• Last Updated: February 12, 2025
• Results First Posted: February 21, 2023

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)