Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support

Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya

To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and self-efficacy. This randomized controlled trial (RCT) aims to determine the effect and mechanisms of a two- way mobile health (mHealth) SMS intervention, Mobile WACh NEO, on neonatal mortality, essential newborn practices, care-seeking and maternal mental health at four sites in Kenya.

Study Overview

• Status: Completed
• Conditions: Depression; Perinatal Death; Neonatal Death
• Intervention / Treatment: Behavioral: Interactive two-way SMS dialogue

Detailed Description

High-impact essential newborn care practices and interventions are available to support neonatal survival, but coverage remains a challenge in sub-Saharan Africa, where neonatal mortality is unacceptably high. Many newborns continue to die at home without health care services being sought. The reasons are multifactorial, at the societal, health system, and family levels. Decisions made within the household and the family's ability to reach care play a large part in determining neonatal outcomes. It is estimated that up to 80% of neonatal and child deaths may have delays in recognition of infant illness and decision to seek care. Two-way mobile health (mHealth) communication strategies can enable mothers to remotely interact with a healthcare worker (HCW) and receive real-time education, counseling, encouragement, motivation and decisional guidance to support care-seeking decisions and ultimately neonatal health and survival.

The investigators developed a unique two-way SMS platform (Mobile WACh) that combines automated SMS messaging and dialogue with a HCW. The team adapted this approach for intensive neonatal support and evaluations (Mobile WACh NEO). Mobile WACh NEO (MWN) enhances the benefits of SMS messaging by engaging mothers with SMS communication and bringing timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions.

This is a randomized controlled trial of the MWN intervention among 5,020 participants (2,510 MWN arm, 2,510 control arm) to determine the effect of MWN on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first 6 weeks postpartum.

Aim 1: To determine the effect of Mobile WACh NEO on neonatal mortality, compared to no SMS control.

Aim 2: To examine the effect of Mobile WACh NEO on maternal implementation of essential newborn care and care seeking behavior.

Aim 3: To examine the effects of Mobile WACh NEO on maternal social support, self-efficacy and depression.

Finally, investigators will explore the associations between maternal mental health, implementation of essential newborn care, neonatal care seeking and participant engagement by SMS.

• Study Type: Interventional
• Enrollment (Actual): 5020
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Bondo, Kenya
    • Bondo Sub-County Referral Hospital
  • Homa Bay, Kenya
    • Rachuonyo County Hospital
  • Kisumu, Kenya
    • Kisumu County Hospital
  • Nairobi, Kenya
    • Mathare North Health Centre
  • Nairobi, Kenya
    • Riruta Health Center
  • Kisumu
    • Ahero, Kisumu, Kenya
      • Ahero Sub-District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant
• 28-36 weeks gestation
• Daily access to a mobile phone (own or shared) on the Safaricom network
• Willing to receive SMS
• Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help

Exclusion Criteria:

• Currently enrolled in another research study
• Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive two-way SMS dialogue; Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.	Behavioral: Interactive two-way SMS dialogue; We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
No Intervention: No SMS Control; Control receiving standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal mortality	Death during 1st 28 days of life	28 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cord care	Number of participants with no application of substances to cord	2-weeks postpartum
Early neonatal mortality	Death during 1st 7 days of life	7 days postpartum
Initiation of early breastfeeding	Number of participants initiating breastfeeding in 1st hour of life	1 hour postpartum
Exclusive breastfeeding	Cessation of exclusive breastfeeding in 1st 6 weeks of life	6-weeks postpartum
Thermal care	Number of participants giving infant a bath in 1st 24 hours of life	24 hours postpartum
Home provision of Kangaroo Mother Care	Number of participants providing any duration of skin-to-skin care on ≥10 of the first 14 days at home, among low birthweight or preterm infants	14 days at home postpartum
Maternal knowledge of neonatal danger signs	Number of danger signs or symptoms successfully named	6-weeks postpartum
Depression	Score above diagnostic threshold (>=13) for Edinburgh Postnatal Depression Scale. Possible scores are 0-30, with a higher score indicating a higher likelihood of possible depressive illness.	Enrollment through 6-weeks postpartum
Social support	Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-100, with a higher score indicating higher levels of social support.	Enrollment through 6-weeks postpartum
Self-efficacy	Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.	Enrollment through 6-weeks postpartum
Appropriate care-seeking	Proportion of illness episodes with danger signs in which the clinic was attended and/or where the infant was hospitalized irrespective of danger signs reported in 1st 18 weeks of life (study follow-up period).	18 weeks postpartum

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Kenyatta National Hospital
• Investigators: Principal Investigator: Jennifer A Unger, MD, MPH, Brown University; Study Director: John Kinuthia, MBChB, MMed, Kenyatta National Hospital

Publications and helpful links

General Publications

• Ronen K, Choo EM, Wandika B, Udren JI, Osborn L, Kithao P, Hedstrom AB, Masinde M, Kumar M, Wamalwa DC, Richardson BA, Kinuthia J, Unger JA. Evaluation of a two-way SMS messaging strategy to reduce neonatal mortality: rationale, design and methods of the Mobile WACh NEO randomised controlled trial in Kenya. BMJ Open. 2021 Dec 23;11(12):e056062. doi: 10.1136/bmjopen-2021-056062.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: depression; Kenya; mHealth; mortality; neonate; SMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Death; Perinatal Death
• Other Study ID Numbers: STUDY00006395; 1R01HD098105-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from Mobile WACh NEO will be available at end of the project by contacting the study team at the University of Washington (neor01@uw.edu).
• IPD Sharing Time Frame: At the end of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No