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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02724969
Acronym
MILK
Enrollment
250
Registered
2016-03-31
Start date
2017-02-10
Completion date
2019-05-13
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding

Keywords

text messaging, short message service

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).

Detailed 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).

Interventions

BEHAVIORALMILK 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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Lactation consultant providing assistance has no knowledge of group assignment. Statistician completing final analysis of data will be blinded to group assignment.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Perception of Milk Supply8 weeks postpartumAssessed 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

Secondary

MeasureTime frameDescription
Breastfeeding Self-efficacy8 weeks postpartumassessed via 14-item Breastfeeding Self-Efficacy Scale (Likert scale) Score range 14-70, with higher scores indicative of higher breastfeeding self-efficacy
Maternal Anxiety and Depression8 weeks postpartum3-item PRAMS (Likert scale for each item 1-5; summative score range 3-15, with higher score indicative of greater depression and/or anxiety)
Breastfeeding Continuation8 weeks postpartumwhether 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
Breastfeeding Exclusivity8 weeks postpartumwhether 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

Countries

United States

Participant flow

Recruitment details

Participants were recruited between February 2017 and May 2018 at prenatal visits at a single academic medical center. Recruitment also occurred through local print advertising, a University research registry, and social media. The first participant was enrolled on February 10, 2017, and the last participant was enrolled on May 14, 2018.

Pre-assignment details

Of 413 participants assessed for eligibility, 250 met eligibility criteria, agreed to participate, and were randomized to a treatment group.

Participants by arm

ArmCount
MILK Intervention Group
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. 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.
126
Text4Baby Control Intervention Group
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. 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.
124
Total250

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyInfant demise02
Overall StudyLost to Follow-up126
Overall StudyWithdrawal by Subject33

Baseline characteristics

CharacteristicText4Baby Control Intervention GroupTotalMILK Intervention Group
Age, Continuous28.7 years
STANDARD_DEVIATION 5.2
28.8 years
STANDARD_DEVIATION 5.3
28.9 years
STANDARD_DEVIATION 5.5
Breastfeeding Self-Efficacy Scale (Short Form) Score Baseline48.1 units on a scale
STANDARD_DEVIATION 8.9
48.1 units on a scale
STANDARD_DEVIATION 8.7
48.0 units on a scale
STANDARD_DEVIATION 8.6
Education level
Associate's degree, vocational degree, or some college
31 Participants56 Participants25 Participants
Education level
Bachelor's degree
33 Participants69 Participants36 Participants
Education level
Highschool or less
13 Participants28 Participants15 Participants
Education level
Postgraduate degree
46 Participants94 Participants48 Participants
Employed at enrollment108 Participants212 Participants104 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants10 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
116 Participants236 Participants120 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Infant Feeding Intentions Scale Score at enrollment10.5 units on a scale
STANDARD_DEVIATION 2.2
10.3 units on a scale
STANDARD_DEVIATION 2.2
10.2 units on a scale
STANDARD_DEVIATION 2.3
Iowa Infant Feeding Attitude Scale62.6 units on a scale
STANDARD_DEVIATION 6.6
62.3 units on a scale
STANDARD_DEVIATION 6.4
62.0 units on a scale
STANDARD_DEVIATION 6.2
Married77 Participants158 Participants81 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants12 Participants7 Participants
Race (NIH/OMB)
Black or African American
22 Participants47 Participants25 Participants
Race (NIH/OMB)
More than one race
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
94 Participants181 Participants87 Participants
Region of Enrollment
United States
124 participants250 participants126 participants
Sex: Female, Male
Female
124 Participants250 Participants126 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Special Supplemental Program for Women, Infants, and Children (WIC) recipient28 Participants60 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1260 / 124
other
Total, other adverse events
0 / 1260 / 124
serious
Total, serious adverse events
0 / 1260 / 124

Outcome results

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

Time frame: 8 weeks postpartum

Population: Not completed by participants who indicated they stopped breastfeeding prior to 8 weeks postpartum; if more than 2 items were not answered on scale, sum scale of score was not computed; if 2 items or less were missing, the missing item(s) score was computed with the mean item score for the scale

ArmMeasureValue (MEAN)Dispersion
MILK Intervention GroupPerception of Milk Supply54.9 score on a scaleStandard Deviation 13
Text4Baby Control Intervention GroupPerception of Milk Supply56.2 score on a scaleStandard Deviation 14.6
p-value: 0.272Mixed Models Analysis
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

Time frame: 8 weeks postpartum

Population: Only includes participants with breastfeeding data available at 8 weeks (i.e., participants who completed breastfeeding survey item(s) at 8 weeks or indicated they stopped breastfeeding prior to 8 weeks); note that some participants do not have 8 week breastfeeding data or 8 week survey data, but went on to complete the study by completing subsequent study timepoints

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MILK Intervention GroupBreastfeeding Continuation98 Participants
Text4Baby Control Intervention GroupBreastfeeding Continuation93 Participants
p-value: 0.78Mixed Models Analysis
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

Time frame: 8 weeks postpartum

Population: Only includes participants with breastfeeding data available at 8 weeks (i.e., participants who completed breastfeeding survey item(s) at 8 weeks or indicated they stopped breastfeeding prior to 8 weeks); note that some participants do not have 8 week breastfeeding data or 8 week survey data, but went on to complete the study by completing subsequent study timepoints

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MILK Intervention GroupBreastfeeding Exclusivity61 Participants
Text4Baby Control Intervention GroupBreastfeeding Exclusivity63 Participants
p-value: 0.588Mixed Models Analysis
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

Time frame: 8 weeks postpartum

Population: Not completed by participants who indicated they stopped breastfeeding prior to 8 weeks postpartum; if no answer provided for more than 2 items in scale, scale score not computed and considered missing data. If \< 2 items on scale incomplete, mean individual score on the other items was imputed for the missing value

ArmMeasureValue (MEAN)Dispersion
MILK Intervention GroupBreastfeeding Self-efficacy51.8 score on a scaleStandard Deviation 11.7
Text4Baby Control Intervention GroupBreastfeeding Self-efficacy53.2 score on a scaleStandard Deviation 12.2
p-value: 0.082Mixed Models Analysis
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)

Time frame: 8 weeks postpartum

Population: Not completed by participants who indicated they had stopped breastfeeding prior to 8 weeks postpartum

ArmMeasureValue (MEAN)Dispersion
MILK Intervention GroupMaternal Anxiety and Depression5.6 score on a scaleStandard Deviation 2.3
Text4Baby Control Intervention GroupMaternal Anxiety and Depression5.2 score on a scaleStandard Deviation 2.3
p-value: 0.355Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026