Trial Outcomes & Findings for A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply (NCT NCT02724969)

Last Updated: 2025-02-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

8 weeks postpartum

Results posted on

2025-02-12

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	126	124
Overall Study COMPLETED	111	113
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	12	6
Overall Study Withdrawal by Subject	3	3
Overall Study Infant demise	0	2

Baseline Characteristics

Ethnicity assessed at baseline with n=247 participants' data available

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	MILK Intervention Group n=98 Participants 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.	Text4Baby Control Intervention Group n=93 Participants 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.
Perception of Milk Supply	54.9 score on a scale Standard Deviation 13.0	56.2 score on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: 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

assessed via 14-item Breastfeeding Self-Efficacy Scale (Likert scale) Score range 14-70, with higher scores indicative of higher breastfeeding self-efficacy

Outcome measures

Outcome measures
Measure	MILK Intervention Group n=98 Participants 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.	Text4Baby Control Intervention Group n=92 Participants 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.
Breastfeeding Self-efficacy	51.8 score on a scale Standard Deviation 11.7	53.2 score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 8 weeks postpartum

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

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)

Outcome measures

Outcome measures
Measure	MILK Intervention Group n=104 Participants 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.	Text4Baby Control Intervention Group n=99 Participants 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.
Maternal Anxiety and Depression	5.6 score on a scale Standard Deviation 2.3	5.2 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	MILK Intervention Group n=112 Participants 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.	Text4Baby Control Intervention Group n=112 Participants 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.
Breastfeeding Continuation	98 Participants	93 Participants

SECONDARY outcome

Timeframe: 8 weeks postpartum

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

Outcome measures

Outcome measures
Measure	MILK Intervention Group n=112 Participants 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.	Text4Baby Control Intervention Group n=112 Participants 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.
Breastfeeding Exclusivity	61 Participants	63 Participants

Adverse Events

MILK Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Text4Baby Control Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jill R. Demirci, PhD, RN, IBCLC

University of Pittsburgh

Phone: 412-648-9236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MILK Intervention Group n=126 Participants 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.	Text4Baby Control Intervention Group n=124 Participants 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.	Total n=250 Participants Total of all reporting groups
Age, Continuous	28.9 years STANDARD_DEVIATION 5.5 • n=126 Participants	28.7 years STANDARD_DEVIATION 5.2 • n=124 Participants	28.8 years STANDARD_DEVIATION 5.3 • n=250 Participants
Sex: Female, Male Female	126 Participants n=126 Participants	124 Participants n=124 Participants	250 Participants n=250 Participants
Sex: Female, Male Male	0 Participants n=126 Participants	0 Participants n=124 Participants	0 Participants n=250 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=124 Participants • Ethnicity assessed at baseline with n=247 participants' data available	7 Participants n=123 Participants • Ethnicity assessed at baseline with n=247 participants' data available	10 Participants n=247 Participants • Ethnicity assessed at baseline with n=247 participants' data available
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=124 Participants • Ethnicity assessed at baseline with n=247 participants' data available	116 Participants n=123 Participants • Ethnicity assessed at baseline with n=247 participants' data available	236 Participants n=247 Participants • Ethnicity assessed at baseline with n=247 participants' data available
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=124 Participants • Ethnicity assessed at baseline with n=247 participants' data available	0 Participants n=123 Participants • Ethnicity assessed at baseline with n=247 participants' data available	1 Participants n=247 Participants • Ethnicity assessed at baseline with n=247 participants' data available
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	0 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	0 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) Asian	7 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	5 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	12 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	0 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	0 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) Black or African American	25 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	22 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	47 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) White	87 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	94 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	181 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) More than one race	3 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	2 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	5 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=124 Participants • Race assessed at baseline with n=247 participants' data available	0 Participants n=123 Participants • Race assessed at baseline with n=247 participants' data available	2 Participants n=247 Participants • Race assessed at baseline with n=247 participants' data available
Region of Enrollment United States	126 participants n=126 Participants	124 participants n=124 Participants	250 participants n=250 Participants
Married	81 Participants n=124 Participants • marital status assessed at baseline with n=247 participants' data available	77 Participants n=123 Participants • marital status assessed at baseline with n=247 participants' data available	158 Participants n=247 Participants • marital status assessed at baseline with n=247 participants' data available
Education level Highschool or less	15 Participants n=124 Participants • education assessed at baseline with n=247 participants' data available	13 Participants n=123 Participants • education assessed at baseline with n=247 participants' data available	28 Participants n=247 Participants • education assessed at baseline with n=247 participants' data available
Education level Associate's degree, vocational degree, or some college	25 Participants n=124 Participants • education assessed at baseline with n=247 participants' data available	31 Participants n=123 Participants • education assessed at baseline with n=247 participants' data available	56 Participants n=247 Participants • education assessed at baseline with n=247 participants' data available
Education level Bachelor's degree	36 Participants n=124 Participants • education assessed at baseline with n=247 participants' data available	33 Participants n=123 Participants • education assessed at baseline with n=247 participants' data available	69 Participants n=247 Participants • education assessed at baseline with n=247 participants' data available
Education level Postgraduate degree	48 Participants n=124 Participants • education assessed at baseline with n=247 participants' data available	46 Participants n=123 Participants • education assessed at baseline with n=247 participants' data available	94 Participants n=247 Participants • education assessed at baseline with n=247 participants' data available
Employed at enrollment	104 Participants n=124 Participants • employment assessed at baseline with n=237 participants' data available	108 Participants n=123 Participants • employment assessed at baseline with n=237 participants' data available	212 Participants n=247 Participants • employment assessed at baseline with n=237 participants' data available
Special Supplemental Program for Women, Infants, and Children (WIC) recipient	32 Participants n=123 Participants • WIC status assessed at baseline with n=246 participants' data available	28 Participants n=123 Participants • WIC status assessed at baseline with n=246 participants' data available	60 Participants n=246 Participants • WIC status assessed at baseline with n=246 participants' data available
Infant Feeding Intentions Scale Score at enrollment	10.2 units on a scale STANDARD_DEVIATION 2.3 • n=124 Participants • Scale administered at baseline with n=246 participants' data available	10.5 units on a scale STANDARD_DEVIATION 2.2 • n=122 Participants • Scale administered at baseline with n=246 participants' data available	10.3 units on a scale STANDARD_DEVIATION 2.2 • n=246 Participants • Scale administered at baseline with n=246 participants' data available
Breastfeeding Self-Efficacy Scale (Short Form) Score Baseline	48.0 units on a scale STANDARD_DEVIATION 8.6 • n=124 Participants • Scale administered at baseline with n=247 participants' data available	48.1 units on a scale STANDARD_DEVIATION 8.9 • n=123 Participants • Scale administered at baseline with n=247 participants' data available	48.1 units on a scale STANDARD_DEVIATION 8.7 • n=247 Participants • Scale administered at baseline with n=247 participants' data available
Iowa Infant Feeding Attitude Scale	62.0 units on a scale STANDARD_DEVIATION 6.2 • n=124 Participants • Scale administered at baseline with n=247 participants' data available	62.6 units on a scale STANDARD_DEVIATION 6.6 • n=123 Participants • Scale administered at baseline with n=247 participants' data available	62.3 units on a scale STANDARD_DEVIATION 6.4 • n=247 Participants • Scale administered at baseline with n=247 participants' data available