Novel Approach To Improving Lactation Support With Mobile Health Technology

NCT03332108 | Completed

• 1 other identifier: 201705027
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Feeding Behavior

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding duration

  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 Outcomes (2)

• Time to transition feeding status

  Six months

• Time to event

  Six months

Other Outcomes (7)

• Time from event to provider intervention

  Six months

• Time to nursing status change

  Six months

• Engagement

  Six months

Study Arms (2)

Intervention

EXPERIMENTAL

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; Other: Baby book survey

Control

OTHER

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

Interventions

EpxBreastfeeding OTHER

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.

Intervention

Baby book survey OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women having given birth with the intention to breastfeed
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator
• Washington University Institute of Clinical and Translational Sciences: collaborator

Study Sites (1)

Washington University School of Medicine, Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

• Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

  PMID: 22371471 BACKGROUND

• Hanieh S, Ha TT, Simpson JA, Thuy TT, Khuong NC, Thoang DD, Tran TD, Tuan T, Fisher J, Biggs BA. Exclusive breast feeding in early infancy reduces the risk of inpatient admission for diarrhea and suspected pneumonia in rural Vietnam: a prospective cohort study. BMC Public Health. 2015 Nov 24;15:1166. doi: 10.1186/s12889-015-2431-9.

  PMID: 26602368 BACKGROUND

• Horta BL, Loret de Mola C, Victora CG. Breastfeeding and intelligence: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):14-9. doi: 10.1111/apa.13139.

  PMID: 26211556 BACKGROUND

• Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.

  PMID: 26192560 BACKGROUND

• Patel S, Patel S. The Effectiveness of Lactation Consultants and Lactation Counselors on Breastfeeding Outcomes. J Hum Lact. 2016 Aug;32(3):530-41. doi: 10.1177/0890334415618668. Epub 2015 Dec 7.

  PMID: 26644419 BACKGROUND

• Tahir NM, Al-Sadat N. Does telephone lactation counselling improve breastfeeding practices? A randomised controlled trial. Int J Nurs Stud. 2013 Jan;50(1):16-25. doi: 10.1016/j.ijnurstu.2012.09.006. Epub 2012 Oct 17.

  PMID: 23084438 BACKGROUND

• Chung M, Ip S, Yu W, Raman G, Trikalinos T, DeVine D, Lau J. Interventions in Primary Care to Promote Breastfeeding: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Oct. Report No.: 09-05126-EF-1. Available from http://www.ncbi.nlm.nih.gov/books/NBK35168/

  PMID: 20722164 BACKGROUND

• Fiscella K, Franks P, Gold MR, Clancy CM. Inequality in quality: addressing socioeconomic, racial, and ethnic disparities in health care. JAMA. 2000 May 17;283(19):2579-84. doi: 10.1001/jama.283.19.2579.

  PMID: 10815125 BACKGROUND

• Lua PL, Neni WS. A randomised controlled trial of an SMS-based mobile epilepsy education system. J Telemed Telecare. 2013 Jan;19(1):23-8. doi: 10.1177/1357633X12473920. Epub 2013 Feb 6.

  PMID: 23390210 BACKGROUND

• Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011 Nov;85(2):323-30. doi: 10.1016/j.pec.2010.11.012. Epub 2010 Dec 13.

  PMID: 21146950 BACKGROUND

• Moniz MH, Meyn LA, Beigi RH. Text Messaging to Improve Preventive Health Attitudes and Behaviors During Pregnancy: A Prospective Cohort Analysis. J Reprod Med. 2015 Sep-Oct;60(9-10):378-82.

  PMID: 26592061 BACKGROUND

• McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.

  PMID: 28244064 BACKGROUND

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

  PMID: 32813276 DERIVED

Related Links

• Clinical guidelines: breastfeeding. American College of Obstetrics and Gynecologists

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Camaryn Chrisman Robbins, MD, MPH

  Associate Professor and Co-Medical Director of Labor and Delivery, Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: November 6, 2017
• Study Start: September 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)