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CompletedNCT04598165Updated Aug 15, 2024Results posted

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

An interventional study of Interactive two-way SMS dialogue in Neonatal Death, Perinatal Death and Depression, sponsored by Women and Infants Hospital of Rhode Island. Completed at 6 sites in Kenya. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
5,020
Allocation
Randomized
Ages
14 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Neonatal Death
  • Perinatal Death
  • Depression

Keywords

  • SMS
  • mHealth
  • neonate
  • mortality
  • depression
  • Kenya
03

In context

Perinatal Death

85 studies on the registry are indexed under Perinatal Death; 20 are open to participants now.

This study's enrollment of 5,020 is above the median of 500 across 58 interventional studies indexed under Perinatal Death.

Browse Perinatal Death studies →

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Currently enrolled in another research study
  • Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,020 participants (actual)

Study arms

  • 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

  • No intervention
    No SMS Control

    Control receiving standard of care.

Interventions

  • BehavioralInteractive 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.

06

What researchers measure

Primary outcomes

  1. Neonatal Mortality

    Death during 1st 28 days of life

    Time frame: 28 days postpartum

Secondary outcomes

  1. Early Neonatal Mortality

    Death during 1st 7 days of life

    Time frame: 7 days postpartum

  2. Initiation of Early Breastfeeding

    Number of participants initiating breastfeeding in 1st hour of life

    Time frame: 1 hour postpartum

  3. Exclusive Breastfeeding

    Exclusive breastfeeding at 6-week visit

    Time frame: 6-weeks postpartum

  4. Thermal Care

    Number of participants not giving infant a bath in 1st 24 hours of life

    Time frame: 24 hours postpartum

  5. Cord Care

    Number of participants with no application of substances to cord

    Time frame: 2-weeks postpartum

  6. 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

    Time frame: 14 days at home postpartum

  7. Maternal Knowledge of Neonatal Danger Signs

    Number of danger signs or symptoms successfully named

    Time frame: Up to 6-weeks postpartum

  8. 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).

    Time frame: 18 weeks postpartum

  9. Elevated Depressive Symptoms

    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.

    Time frame: Enrollment through 6-weeks postpartum

  10. 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.

    Time frame: Enrollment through 6-weeks postpartum

  11. Self-efficacy

    Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.

    Time frame: Enrollment through 6-weeks postpartum

07

Results

Posted Aug 15, 2024
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.

Participant flow

Pregnant women were recruited when attending routine antenatal care through referral to study staff. Those interested were asked to provide verbal consent for screening to assess eligibility, and if eligible, they were invited to participate in the study. Women were followed until 6 weeks postpartum but their infants were not considered enrolled. Infant outcomes were obtained from the participants and considered participant outcomes.

Completed 6-week Follow-up
Participant flow — Completed 6-week Follow-up
MilestoneInteractive Two-way Text Messaging DialogueNo SMS Control
Started25092511
Completed24712470
Not completed3841
Withdrew: Withdrawal by subject63
Withdrew: Death21
Withdrew: Lost to follow-up2633
Withdrew: Ineligible43
Withdrew: Partner refusal01
Included in Intention to Treat Analysis
Participant flow — Included in Intention to Treat Analysis
MilestoneInteractive Two-way Text Messaging DialogueNo SMS Control
Started25092511
Completed24422442
Not completed6769
Withdrew: Ineligible for inclusion in analysis6769

Outcome measures

PrimaryNeonatal Mortality

Death during 1st 28 days of life

Time frame:
28 days postpartum
Reported as:
Count of participants · Participants
Neonatal Mortality
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Neonatal Mortality4637
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.314 (The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.25 · 95% CI 0.81 to 1.92SMS group is the numerator
SecondaryEarly Neonatal Mortality

Death during 1st 7 days of life

Time frame:
7 days postpartum
Reported as:
Count of participants · Participants
Early Neonatal Mortality
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Early Neonatal Mortality3828
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.217 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.36 · 95% CI 0.84 to 2.21SMS group is the numerator
SecondaryInitiation of Early Breastfeeding

Number of participants initiating breastfeeding in 1st hour of life

Time frame:
1 hour postpartum
Reported as:
Count of participants · Participants
Initiation of Early Breastfeeding
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Initiation of Early Breastfeeding15101402
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.064 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.04 · 95% CI 1.00 to 1.08SMS group is the numerator
SecondaryExclusive Breastfeeding

Exclusive breastfeeding at 6-week visit

Time frame:
6-weeks postpartum
Reported as:
Count of participants · Participants
Exclusive Breastfeeding
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Exclusive Breastfeeding21902217
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.363 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 0.99 · 95% CI 0.98 to 1.01SMS group is the numerator
SecondaryThermal Care

Number of participants not giving infant a bath in 1st 24 hours of life

Time frame:
24 hours postpartum
Reported as:
Count of participants · Participants
Thermal Care
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Thermal Care22452232
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.093 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.01 · 95% CI 1.00 to 1.02SMS group is the numerator
SecondaryCord Care

Number of participants with no application of substances to cord

Time frame:
2-weeks postpartum
Reported as:
Count of participants · Participants
Cord Care
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Cord Care11231104
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.353 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.03 · 95% CI 0.97 to 1.09SMS group is the numerator
SecondaryHome 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

Time frame:
14 days at home postpartum
Reported as:
Count of participants · Participants
Home Provision of Kangaroo Mother Care
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Home Provision of Kangaroo Mother Care1210
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.751 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.14 · 95% CI 0.50 to 2.61SMS group is the numerator
SecondaryMaternal Knowledge of Neonatal Danger Signs

Number of danger signs or symptoms successfully named

Time frame:
Up to 6-weeks postpartum
Reported as:
Median · Number of danger signs named
Maternal Knowledge of Neonatal Danger Signs
Number of danger signs namedInteractive Two-way SMS DialogueNo SMS Control
Maternal Knowledge of Neonatal Danger Signs3 (2 to 4)2 (2 to 3)
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson generalized estimating equations · p = 0.431 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.00 · 95% CI 1.00 to 1.01n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.
SecondaryAppropriate 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).

Time frame:
18 weeks postpartum
Reported as:
Count of participants · Participants
Appropriate Care-seeking
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Appropriate Care-seeking204160
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson regression · p = 0.321 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.03 · 95% CI 0.98 to 1.08SMS group is the numerator.
SecondaryElevated Depressive Symptoms

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.

Time frame:
Enrollment through 6-weeks postpartum
Reported as:
Count of participants · Participants
Elevated Depressive Symptoms
ParticipantsInteractive Two-way SMS DialogueNo SMS Control
Elevated Depressive Symptoms3840
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Poisson generalized estimating equations · p = 0.650 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Risk ratio (rr): 1.01 · 95% CI 0.98 to 1.04n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.
SecondarySocial 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.

Time frame:
Enrollment through 6-weeks postpartum
Reported as:
Median · score on a scale
Social Support
score on a scaleInteractive Two-way SMS DialogueNo SMS Control
Social Support84.2 (69.7 to 100)84.2 (68.4 to 100)
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Linear generalized estimating equations · p = 0.071 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Coefficient: 0.09 · 95% CI -0.007 to 0.18n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.
SecondarySelf-efficacy

Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.

Time frame:
Enrollment through 6-weeks postpartum
Reported as:
Median · score on a scale
Self-efficacy
score on a scaleInteractive Two-way SMS DialogueNo SMS Control
Self-efficacy45 (43 to 45)45 (43 to 45)
Statistical analysis
  • Interactive Two-way SMS Dialogue vs No SMS Control · Linear generalized estimating equations · p = 0.190 (The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.) · Coefficient: 0.02 · 95% CI -0.01 to 0.04n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.

Adverse events

Collected over Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Interactive Two-way SMS Dialogue2/2,505 (0.1%)171/2,505 (6.8%)7/2,505 (0.3%)
No SMS Control2/2,508 (0.1%)114/2,508 (4.5%)2/2,508 (0.1%)
Most frequent serious events
Most frequent serious events
EventInteractive Two-way SMS DialogueNo SMS Control
Infant hospitalizationGeneral disorders90/247146/2469
Infant deathPregnancy, puerperium and perinatal conditions54/244139/2442
StillbirthPregnancy, puerperium and perinatal conditions34/250539/2508
Maternal hospitalizationGeneral disorders33/250511/2508
Maternal deathPregnancy, puerperium and perinatal conditions2/25052/2508
Maternal disappearanceGeneral disorders1/25050/2508
Most frequent other events
Most frequent other events
EventInteractive Two-way SMS DialogueNo SMS Control
Social harmSocial circumstances7/25052/2508

Baseline characteristics

Seven (7) enrolled participants excluded from analysis due to ineligibility.

Age, Continuous
Age, Continuous(years)Interactive Two-way SMS DialogueNo SMS ControlTotal
Median25 (22 to 29)25 (22 to 29)25 (22 to 29)
Sex: Female, Male
Sex: Female, Male(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Female250525085013
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American250525085013
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Kenya250525085013
<12 years of education
<12 years of education(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Count of participants103710052042
Household crowding (>3 people per room)
Household crowding (>3 people per room)(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Count of participants399371770
Married/cohabitating
Married/cohabitating(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Count of participants200020504050
Employed
Employed(Participants)Interactive Two-way SMS DialogueNo SMS ControlTotal
Count of participants9439211864

13 further baseline measures are reported on the registry.

08

Study locations

6 sites
  • Ahero Sub-District Hospital
    Ahero, Kisumu, Kenya
  • Bondo Sub-County Referral Hospital
    Bondo, Kenya
  • Rachuonyo County Hospital
    Homa Bay, Kenya
  • Kisumu County Hospital
    Kisumu, Kenya
  • Mathare North Health Centre
    Nairobi, Kenya
  • Riruta Health Center
    Nairobi, Kenya
09

References and documents

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. PubMed 34949631 ↗

Study documents

  • Study protocol · Oct 1, 2021
  • Statistical analysis plan · May 31, 2024
  • Informed consent form · Jul 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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).

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04598165
Lead sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital
Responsible party
Jennifer Unger (Associate Professor, Department of Obstetrics and Gynecology, University of Washington) — Principal investigator
First posted
Oct 22, 2020
Start date
Sep 7, 2020
Primary completion
Feb 20, 2023
Completion
Feb 20, 2023
Results posted
Aug 15, 2024
Last update
Aug 15, 2024

Study contacts

Jennifer A Unger, MD, MPH
principal investigator · Brown University
John Kinuthia, MBChB, MMed
study director · Kenyatta National Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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