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Novel Approach To Improving Lactation Support With Mobile Health Technology

Novel Approach to Improving Lactation Support Using Mobile Health Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03332108
Enrollment
218
Registered
2017-11-06
Start date
2017-09-01
Completion date
2018-12-30
Last updated
2019-07-02

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

Conditions

Breastfeeding, Feeding Behavior

Keywords

mobile health (mHealth), electronic health (eHealth), breastfeeding, infant nutrition, text messaging intervention

Brief summary

This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.

Detailed description

Immediately following delivery, mothers are given the task of learning to care for a newborn, coping with rapid hormone changes, and in many cases, learning to breastfeed, all with minimal contact with their obstetric provider. Traditionally, women are not seen by their obstetrician until 6 weeks postpartum, increasing the likelihood that they will switch to formula feeding despite a clear antenatal intent to breastfeed. Data suggests that exclusive breastfeeding for the first six months of life is associated with lower rates of respiratory and ear infections in babies with fewer required hospitalizations, due to the protective effect of maternal antibodies in breast milk. Fewer children go on to develop asthma and allergies. Additionally, adolescents who were breastfed demonstrate higher intelligence quotient (IQ) averages that their peers who were not. The benefits of breastfeeding for mothers include healthy weight loss and protection against ovarian and breast cancer, as well as psychological wellness through maternal-infant bonding. The World Health Organization (WHO) has published extensive data to support recommendations for exclusive breastfeeding in the first 6-month period. Exclusive breastfeeding is defined as the infant's only source of nutrition being human breast milk (along with vitamins, minerals, and medications). While the WHO and the American Congress of Obstetricians and Gynecologists (ACOG) recommend 6 months of exclusive breastfeeding, data published by the Centers for Disease Control (CDC) in 2016 show that only 81.1% of mothers ever try breastfeeding, only 44.4% exclusively breastfeed through 3 months, and only 22.3% exclusively breastfeed over 6 months. In Missouri, the CDC's report card data shows that 85.4% of mothers ever breastfed, and rates of exclusive breastfeeding were 49.7% and 24.7% at 3 and 6 months respectively. At the investigators' local hospital, a recent chart review as part of the Barnes Jewish Hospital's Baby Friendly designation process demonstrated that only 45% of mothers who received prenatal care at the Center for Advanced Medicine (CAM) or the Center for Outpatient Health (COH) were exclusively breastfeeding at 6 weeks postpartum (unpublished data). In order to reach the Healthy People 2020 goals of 42.6% breastfeeding at 3 months and 60.6% at 6 months, it is important to identify modifiable barriers to optimal breastfeeding practices and create innovative solutions to address them. One of these barriers is access to lactation support. Mothers frequently have difficulty becoming familiar with the process of breastfeeding during the immediate postpartum period. Difficulty latching or inadequate milk production are the most common causes of concern, driving mothers to supplement with or switch to milk formula products. Once efforts to breastfeed cease, mammary milk production slows and cannot be restarted. Mothers who have started formula feeds at time of discharge from the hospital are five times more likely to stop breastfeeding completely in the first week. The ACOG strongly supports breastfeeding, recognizing it as a public health priority, and has promoted the implementation of clinical resources in hospital systems nationwide. Many hospitals employ dedicated professionals trained in breastfeeding (lactation consultants and obstetric and postpartum nurses trained specifically in lactation support) to counsel and assist mothers, and the use of lactation consultants has been shown to significantly increase breastfeeding rates. Unfortunately, trends show that after mothers and infants are discharged from the hospital, they lose connection with these providers. The lack of support is one of many factors that may lead to cessation of exclusive breastfeeding. In typical postpartum practice, patients return to their obstetrics provider for a visit at 6 weeks. This is inadequate for addressing breastfeeding concerns, as it occurs too late to promote a return to a breastfeeding. Proactive outreach in busy obstetrics practices is expensive, time-consuming and inefficient due to challenges with identifying and targeting resources to mothers who are most in need of a help achieving their breastfeeding goals. Postpartum visits are, by default, included in a patient's global obstetric package and providers are in many cases unable to bill separately for lactation support visits, which can make it harder for mothers and providers to address issues earlier postpartum. Ideally, an approach to improving patient/provider communication in the 2 postpartum weeks when most breastfeeding challenges arise would provide support out of the office setting, with follow up through 6 months. The system must ideally be low cost, low tech, and efficient enough to be implemented widely. Short message service (SMS) texting interventions mark a novel entry point to the healthcare field and enable targeting to patients across the socioeconomic spectrum. Every cell phone is equipped for SMS texting. This form of communication also allows the patient to respond to prompt messages, thereby reducing the burden on patients to initiate communication. Breastfeeding improves maternal and infant health. Most expert bodies recommend at least 6 months of exclusive breastfeeding. Unfortunately, breastfeeding can be difficult to start and sustain due to a variety of mostly treatable factors; many mothers are currently left to navigate these difficulties on their own. The investigators hypothesize that close and individualized assistance will increase the rates of exclusive breastfeeding. To achieve this, a novel, automated, two-way text messaging platform has been developed. This system offers encouragement and education but perhaps more importantly, it collects and categorizes feedback from each mother to identify those that may benefit from personalized follow-up by a trained professional. This system was developed by a team of students and healthcare professionals. The investigators propose implementing it in obstetrics clinics at BJH, and will study its impact through quantitative measures and feedback. If successful, this proposal will create a scalable technological solution to improve breastfeeding adherence. Hypothesis: An automated bidirectional communication tool (EpxBreastfeeding) to monitor nursing status and assess for common problems related to breastfeeding will improve provider awareness and expedite personal follow-up with patients identified as at risk of stopping breastfeeding, and will improve breastfeeding adherence over time compared to controls. Specific Aims: 1. Determine if exclusive breastfeeding duration can be improved by using an automated bidirectional communication tool compared to standard of care through six months postpartum. 2. Compare time-to-event incidence reporting and subsequent provider response time to duration of breastfeeding status (intervention cohort only). 3. Collect subjective data from mothers receiving the intervention, as well as ancillary professionals who are designated for notification and follow-up to consider the feasibility and acceptance of an automated bidirectional mHealth lactation support intervention in the clinical setting.

Interventions

OTHEREpxBreastfeeding

We developed an algorithm using the Epharmix platform, an automated toll-free phone and text message-based system that can programmatically query patients via their personal phones and subsequently collect response data, allowing clinically-relevant responses to trigger alerts to designated healthcare providers. The intervention for breastfeeding, hereafter referred to as EpxBreastfeeding, was built using significant clinical and patient input to only ask the most clinically-relevant questions for breastfeeding in a multiple-choice manner, such as In the past \[x\] days, have you fed your baby 1) breast milk only, 2) breast milk and formula or 3) formula only?. These communications elicit patient-reports of breastfeeding at intervals of interest for the provider, which is, on average, every 2 days in the first three weeks postpartum and every 5 days subsequently. All data is filtered by clinician-designed algorithms to stratify patients into categories.

OTHERBaby book survey

We developed a baby book template that will be given to mothers allowing them to make note of dates related to their child's development during the first year. Examples include: When was baby's first appointment with his/her pediatrician? When did you add formula into baby's feeding? When did you start feeding baby only formula? When did you introduce solid food into baby's diet? When did baby first smile? When did you start reading to baby? What was the first book you read to baby? Whe

Sponsors

Barnes-Jewish Hospital
CollaboratorOTHER
Washington University Institute of Clinical and Translational Sciences
CollaboratorUNKNOWN
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Pregnant women age 18 to 40 years * Singleton birth (e.g. no twins or triplets) * Prenatal intention to breastfeed * Have a mobile phone capable of receiving SMS text messages and phone calls * Know how to send a text message * ≥4th grade literacy level

Exclusion criteria

* Non-fluent in English * Known fetal anomaly * Infant delivery \<37 weeks * \>3 days in neonatal intensive care unit (NICU) * Medical history: pre-pregnancy BMI \>50, history of thyroid disorders, failed one hour and three hour glucola test or if they ever needed oral hypoglycemic, hypertension (HTN) before/during pregnancy, postpartum hemorrhage * Medically contraindicated for breastfeeding (provider's judgment) * Women who will breastfeed but not from their own breast (e.g. buy breast milk on the Internet/milk bank) * Women who are hesitant about answering a series of text messages regularly * Women who are unable to be contacted by SMS text message or are unwilling to provide their contact number * Women with neurologic, anatomic, or cognitive disorders that are unable to consent and/or answer text messages

Design outcomes

Primary

MeasureTime frameDescription
Exclusive breastfeeding durationSix monthsThe primary outcome is the length of time mothers exclusively breastfeed (i.e. continuous length of time for which mothers only give breast milk).

Secondary

MeasureTime frameDescription
Time to transition feeding statusSix monthsTime to transition from exclusive breastfeeding to partial breastfeeding (supplementing breast milk with formula) as well as supplemental nursing only.
Time to eventSix monthsTime to reported problems with: latching, concern regarding deficiency in milk production, concern for inadequate child's weight gain

Other

MeasureTime frameDescription
Patient Satisfaction with Provider, Service and SurveySix monthsPatient satisfaction with provider, communication with provider, frequency of messages, and how likely to recommend the service to a friend measured by automated quality surveys sent each month, with quality ratings of 1-9.
Breastfeeding status at 6 weeks postpartumSix weeksCompare the proportion of mothers exclusively breastfeeding, mixed feeding, and formula feeding at 6 weeks postpartum between control and intervention arms
Time from event to provider interventionSix monthsTime from reported lactation/nursing problem to provider intervention.
Proportion of mothers exclusively breastfeeding at 6 months postpartumSix monthsCompare the proportion of mother exclusively breastfeeding at 6 months postpartum between control and intervention arms
Breastfeeding status at 3 months postpartumThree monthsCompare the proportion of mothers exclusively breastfeeding, mixed feeding, and formula feeding at 3 months postpartum between control and intervention arms
Time to nursing status changeSix monthsTime from provider intervention to change in nursing status (exploratory analysis of each problem reported)
EngagementSix monthsWeekly, monthly, and gross response rate to text messages

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026