Clinical trial NCT03332108: Novel Approach To Improving Lactation Support With Mobile Health Technology
Official title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Feeding Behavior
Keywords: mobile health (mHealth)
electronic health (eHealth)
breastfeeding
infant nutrition
text messaging intervention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
name: Washington University Institute of Clinical and Translational Sciences
First posted: 2017-11-06
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding duration
timeFrame: Six months
Secondary outcomes:
measure: Time to transition feeding status
timeFrame: Six months
measure: Time to event
timeFrame: Six months
Other outcomes:
measure: Time from event to provider intervention
timeFrame: Six months
measure: Time to nursing status change
timeFrame: Six months
measure: Engagement
timeFrame: Six months
measure: Patient Satisfaction with Provider, Service and Survey
timeFrame: Six months
measure: Breastfeeding status at 6 weeks postpartum
timeFrame: Six weeks
measure: Breastfeeding status at 3 months postpartum
timeFrame: Three months
measure: Proportion of mothers exclusively breastfeeding at 6 months postpartum
timeFrame: Six months
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Associate Professor and Co-Medical Director of Labor and Delivery, Washington University School of Medicine
name: Camaryn Chrisman Robbins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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