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

NCT04598165 | Completed Results DMC

• 2 other identifiers: STUDY000063951R01HD098105-01
• Study Type: interventional
• Target: 5,020
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Neonatal Death; Perinatal Death; Depression

Keywords

SMS; mHealth; neonate; mortality; depression; Kenya

Outcome Measures

Primary Outcomes (1)

• Neonatal Mortality

  Death during 1st 28 days of life

  28 days postpartum

Secondary Outcomes (11)

• Early Neonatal Mortality

  7 days postpartum

• Initiation of Early Breastfeeding

  1 hour postpartum

• Exclusive Breastfeeding

  6-weeks postpartum

• Thermal Care

  24 hours postpartum

• Cord Care

  2-weeks postpartum

Study Arms (2)

Interactive two-way SMS dialogue

EXPERIMENTAL

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

No SMS Control

NO INTERVENTION

Control receiving standard of care.

Interventions

Interactive two-way SMS dialogue BEHAVIORAL

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.

Interactive two-way SMS dialogue

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Kenyatta National Hospital: collaborator

Study Sites (6)

Ahero Sub-District Hospital

Ahero, Kisumu County, Kenya

Location

Bondo Sub-County Referral Hospital

Bondo, Kenya

Location

Rachuonyo County Hospital

Homa Bay, Kenya

Location

Kisumu County Hospital

Kisumu, Kenya

Location

Mathare North Health Centre

Nairobi, Kenya

Location

Riruta Health Center

Nairobi, Kenya

Location

Related Publications (2)

• 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.

  PMID: 34949631 BACKGROUND

• Unger JA, Kinuthia J, Wandika B, Hedstrom A, Wetzler E, Udren JI, Masinde M, Choo EM, Schultes O, Kithao P, Moraa J, Akinyi E, Osborn L, Nzove E, Richardson BA, Kumar M, Wamalwa D, Ronen K. The impact of interactive text communication on neonatal mortality in Kenya: a randomized controlled trial. Nat Med. 2025 Jun;31(6):1847-1854. doi: 10.1038/s41591-025-03576-z. Epub 2025 Mar 12.

  PMID: 40075230 DERIVED

MeSH Terms

Conditions

Perinatal Death; Depression

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

The individual rather than cluster level randomization may have led to contamination. Nurse text responses came mostly during the day and thus limited the intervention's ability to address time-sensitive concerns. Limited access to facility records also posed challenges to understanding details of clinical care. The study was not powered to find a mortality difference between the arms among babies who died after discharge from delivery hospitalization, for whom the intervention was designed.

Results Point of Contact

• Title: Jennifer Unger, MD, MPH. Associate Professor, Department of Obstetrics and Gynecology
• Organization: Women and Infants Hospital of Rhode Island

jennifer_unger@brown.edu

(401) 274-1122

Study Officials

• Jennifer A Unger, MD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

• John Kinuthia, MBChB, MMed

  Kenyatta National Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics and Gynecology

Model Details: Participants will be randomized to 1) Interactive two-way SMS dialogue or 2) Control (no SMS), using 1:1 allocation.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 22, 2020
• Study Start: September 7, 2020
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the end of the project.

Locations

KE (6)