Breast Feeding
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Perception of Milk Supply | 8 weeks postpartum | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Self-efficacy | 8 weeks postpartum | assessed 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 Depression | 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) |
| Breastfeeding Continuation | 8 weeks postpartum | 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 |
| Breastfeeding Exclusivity | 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 |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Infant demise | 0 | 2 |
| Overall Study | Lost to Follow-up | 12 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Text4Baby Control Intervention Group | Total | MILK Intervention Group |
|---|---|---|---|
| Age, Continuous | 28.7 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 Baseline | 48.1 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 Participants | 56 Participants | 25 Participants |
| Education level Bachelor's degree | 33 Participants | 69 Participants | 36 Participants |
| Education level Highschool or less | 13 Participants | 28 Participants | 15 Participants |
| Education level Postgraduate degree | 46 Participants | 94 Participants | 48 Participants |
| Employed at enrollment | 108 Participants | 212 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 236 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Infant Feeding Intentions Scale Score at enrollment | 10.5 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 Scale | 62.6 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 |
| Married | 77 Participants | 158 Participants | 81 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 47 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 94 Participants | 181 Participants | 87 Participants |
| Region of Enrollment United States | 124 participants | 250 participants | 126 participants |
| Sex: Female, Male Female | 124 Participants | 250 Participants | 126 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Special Supplemental Program for Women, Infants, and Children (WIC) recipient | 28 Participants | 60 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 124 |
| other Total, other adverse events | 0 / 126 | 0 / 124 |
| serious Total, serious adverse events | 0 / 126 | 0 / 124 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MILK Intervention Group | Perception of Milk Supply | 54.9 score on a scale | Standard Deviation 13 |
| Text4Baby Control Intervention Group | Perception of Milk Supply | 56.2 score on a scale | Standard Deviation 14.6 |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MILK Intervention Group | Breastfeeding Continuation | 98 Participants |
| Text4Baby Control Intervention Group | Breastfeeding Continuation | 93 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MILK Intervention Group | Breastfeeding Exclusivity | 61 Participants |
| Text4Baby Control Intervention Group | Breastfeeding Exclusivity | 63 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MILK Intervention Group | Breastfeeding Self-efficacy | 51.8 score on a scale | Standard Deviation 11.7 |
| Text4Baby Control Intervention Group | Breastfeeding Self-efficacy | 53.2 score on a scale | Standard Deviation 12.2 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MILK Intervention Group | Maternal Anxiety and Depression | 5.6 score on a scale | Standard Deviation 2.3 |
| Text4Baby Control Intervention Group | Maternal Anxiety and Depression | 5.2 score on a scale | Standard Deviation 2.3 |