Novel Approach To Improving Lactation Support With Mobile Health Technology

June 28, 2019 updated by: Washington University School of Medicine

Novel Approach to Improving Lactation Support Using Mobile Health Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Barnes Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Those allocated to the intervention arm will be enrolled in the mHealth intervention (EpxBreastfeeding) for six months, and will also be asked about breastfeeding status at their six-week postpartum follow up visit (standard of care) as well as during phone interviews at three and six months postpartum.
Other: EpxBreastfeeding
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.
Other: Baby 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
Other: Control
Those in the control arm will be asked about breastfeeding status (exclusive, supplementing, or formula only) at their six-week postpartum follow up visit (standard of care) as well as during phone interviews at three and six months postpartum.
Other: Baby 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding duration
Time Frame: Six months
The primary outcome is the length of time mothers exclusively breastfeed (i.e. continuous length of time for which mothers only give breast milk).
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to transition feeding status
Time Frame: Six months
Time to transition from exclusive breastfeeding to partial breastfeeding (supplementing breast milk with formula) as well as supplemental nursing only.
Six months
Time to event
Time Frame: Six months
Time to reported problems with: latching, concern regarding deficiency in milk production, concern for inadequate child's weight gain
Six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from event to provider intervention
Time Frame: Six months
Time from reported lactation/nursing problem to provider intervention.
Six months
Time to nursing status change
Time Frame: Six months
Time from provider intervention to change in nursing status (exploratory analysis of each problem reported)
Six months
Engagement
Time Frame: Six months
Weekly, monthly, and gross response rate to text messages
Six months
Patient Satisfaction with Provider, Service and Survey
Time Frame: Six months
Patient 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.
Six months
Breastfeeding status at 6 weeks postpartum
Time Frame: Six weeks
Compare the proportion of mothers exclusively breastfeeding, mixed feeding, and formula feeding at 6 weeks postpartum between control and intervention arms
Six weeks
Breastfeeding status at 3 months postpartum
Time Frame: Three months
Compare the proportion of mothers exclusively breastfeeding, mixed feeding, and formula feeding at 3 months postpartum between control and intervention arms
Three months
Proportion of mothers exclusively breastfeeding at 6 months postpartum
Time Frame: Six months
Compare the proportion of mother exclusively breastfeeding at 6 months postpartum between control and intervention arms
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Barnes-Jewish Hospital
Washington University Institute of Clinical and Translational Sciences

Investigators

  • Principal Investigator: Camaryn Chrisman Robbins, MD, MPH, Associate Professor and Co-Medical Director of Labor and Delivery, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201705027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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