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

Breast Feeding Clinical Trial

— MILK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724969
• Other study ID #: PRO16020007
• Secondary ID: 5R00NR015106
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: May 13, 2019

Study information

• Verified date: February 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The purpose of the MILK Trial is to examine and compare the effectiveness, feasibility, and acceptability of a semi-automated, text-based, theory-driven intervention ("MILK" intervention) to prevent perceived insufficient milk and its potential inter-related sequelae, including maternal anxiety and early breastfeeding cessation, among mothers without breastfeeding experience who intend to exclusively or nearly exclusively breastfeed. Specifically, the investigators will:

1. Determine the effect of the MILK intervention on perceived insufficient milk supply (PIM) and related maternal psychological and behavioral sequelae.

Compared to the control intervention group ("Text4Baby"), the investigators hypothesize that MILK participants will have a perception of greater breast milk volume/supply, higher self-reported breastfeeding confidence, lower anxiety scores, and longer duration of exclusive breastfeeding.

2. Assess the feasibility of a semi-automated text-based PIM intervention (MILK) for mothers.

The investigators will compare characteristics of women who are and who are not eligible for, chose to participate in, and complete this randomized pilot intervention study. The investigators will also conduct post-study individual interviews with mothers to determine how the interventions were used and perceived (e.g., burden, challenges).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 13, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Pregnant women who:

1. are = 18 years;

2. are between 13-25 gestational weeks;

3. have no prior breastfeeding experience or other living biological children;

4. have a personal cell phone with internet access and an unlimited text message plan; and

5. 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:

1. 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);

2. current gestation of = 1 fetus;

3. contraindications to breastfeeding as specified by the American Academy of Pediatrics (e.g., HIV+ status).

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Behavioral:
• MILK or Text4Baby text message intervention
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breastfeeding Self-efficacy	assessed via 14-item Breastfeeding Self-Efficacy Scale (Likert scale) Score range 14-70, with higher scores indicative of higher breastfeeding self-efficacy	8 weeks postpartum
Secondary	Maternal Anxiety and Depression	3-item PRAMS (Likert scale for each item 1-5; summative score range 3-15, with higher score indicative of greater depression and/or anxiety)	8 weeks postpartum
Secondary	Breastfeeding Continuation	whether participant is doing any breastfeeding at 8 week assessment; dichotomous (yes/no); count represents "yes," participants indicating they are doing any breastfeeding at 8 weeks; abstracted from survey item assessing all feeding method(s) at 8 weeks	8 weeks postpartum
Secondary	Breastfeeding Exclusivity	whether participant is feeding 100% breast milk; dichotomous (yes/no), count represents "yes", exclusive breastfeeding/100% breast milk; abstracted from survey item assessing all feeding method(s) at 8 weeks	8 weeks postpartum