Breast FeedingMILKNCT02724969
A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
A study testing MILK or Text4Baby text message intervention in people with Breast Feeding, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- MILK or Text4Baby text message intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 13 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
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).
Read the 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:
- 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.
- 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).
- Conditions
- Breast Feeding
- Being tested
- MILK or Text4Baby text message intervention
- Keywords
- text messaging, short message service
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILK or Text4Baby text message interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MILK or Text4Baby text message intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks postpartum
Secondary outcomes (4)
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
Measured: 8 weeks postpartum
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)
Measured: 8 weeks postpartum
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
Measured: 8 weeks postpartum
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
Measured: 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start10 Feb 2017
- Primary completion4 Jan 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh
- Investigators
- Jill Demirci, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724969
- Sponsor's protocol ID
- PRO16020007
- Other IDs
- 5R00NR015106
- Acronym
- MILK
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2016
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32347815
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
- ClinicalTrials.gov ID
- NCT02724969
- Acronym / sponsor ID
- MILK / PRO16020007
- Conditions
- Breast Feeding
- Keywords
- text messaging, short message service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MILK intervention group | Experimental | Behavioral: MILK or Text4Baby text message interventionSemi-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. |
| Text4Baby control intervention group | Active comparator | Behavioral: MILK or Text4Baby text message interventionText4Baby 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILK or Text4Baby text message interventionMILK 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. | Behavioural | MILK intervention group, Text4Baby control intervention group |
Primary outcome
Perception of Milk Supply
Time frame: 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
4 secondary outcomes
Breastfeeding Self-efficacy
Time frame: 8 weeks postpartum
Maternal Anxiety and Depression
Time frame: 8 weeks postpartum
Breastfeeding Continuation
Time frame: 8 weeks postpartum
Breastfeeding Exclusivity
Time frame: 8 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32347815Demirci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Demirci, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILK or Text4Baby text message intervention in people with Breast Feeding, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Milk Supply (time frame: 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.