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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD098105-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Kenyatta National Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No SMS Control | No Intervention | Control receiving standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Mortality | Death during 1st 28 days of life | 28 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Unger, MD, MPH | Brown University | Principal Investigator |
| John Kinuthia, MBChB, MMed | Kenyatta National Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahero Sub-District Hospital | Ahero | Kisumu County | Kenya | |||
| Bondo Sub-County Referral Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34949631 | Background | 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. | |
| 40075230 | Derived | 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. |
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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).
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At the end of the project.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interactive Two-way Text Messaging 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. 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. |
| FG001 | No SMS Control | Control receiving standard of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed 6-week Follow-up |
|
| |||||||||||||||||||||
| Included in Intention to Treat Analysis |
|
Seven (7) enrolled participants excluded from analysis due to ineligibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Mortality | Death during 1st 28 days of life | Intention-to-treat for participants with a known infant outcome at 6 weeks postpartum. Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth. | Posted | Count of Participants | Participants | 28 days postpartum |
|
Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social harm | Social circumstances | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Unger, MD, MPH. Associate Professor, Department of Obstetrics and Gynecology | Women and Infants Hospital of Rhode Island | (401) 274-1122 | 48554 | jennifer_unger@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | May 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2024 | May 31, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2021 | May 31, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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Participants will be randomized to 1) Interactive two-way SMS dialogue or 2) Control (no SMS), using 1:1 allocation.
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|
| 1 hour postpartum |
| Exclusive Breastfeeding | Exclusive breastfeeding at 6-week visit | 6-weeks postpartum |
| Thermal Care | Number of participants not giving infant a bath in 1st 24 hours of life | 24 hours postpartum |
| Cord Care | Number of participants with no application of substances to cord | 2-weeks 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 | Up to 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 |
| 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. | 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 |
| Bondo |
| Kenya |
| Rachuonyo County Hospital | Homa Bay | Kenya |
| Kisumu County Hospital | Kisumu | Kenya |
| Mathare North Health Centre | Nairobi | Kenya |
| Riruta Health Center | Nairobi | Kenya |
| Lost to Follow-up |
|
| Ineligible |
|
| Partner refusal |
|
| NOT COMPLETED |
|
|
| BG001 | No SMS Control | Control receiving standard of care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| <12 years of education | Count of Participants | Participants |
|
| Household crowding (>3 people per room) | Count of Participants | Participants |
|
| Married/cohabitating | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Shares mobile phone | Count of Participants | Participants |
|
| Can read SMS unassisted | Count of Participants | Participants |
|
| Can write SMS unassisted | Count of Participants | Participants |
|
| Received health SMS messages from another program | Count of Participants | Participants |
|
| Intimate partner violence in last month | Count of Participants | Participants |
|
| Primigravida | Count of Participants | Participants |
|
| Twins | Count of Participants | Participants |
|
| Estimated gestational age in weeks at baseline | Mean | Inter-Quartile Range | weeks |
|
| HIV positive | Count of Participants | Participants |
|
| Elevated depressive symptoms defined as a score ≥13 on Edinburgh Postnatal Depression Score (EPDS) | Count of Participants | Participants |
|
| Self-reported social support score using the MOS social support survey | Higher numbers indicate more social support. | Median | Inter-Quartile Range | units on a scale from 0-100 |
|
| Parenting self-efficacy using the Karitane Parenting Confidence Scale (KPCS) | Higher numbers indicate more confidence. | Median | Inter-Quartile Range | units on a scale from 0-45 |
|
| Enrollment clinic | Count of Participants | Participants |
|
| OG001 | No SMS Control | Control receiving standard of care. |
|
|
|
| Secondary | Early Neonatal Mortality | Death during 1st 7 days of life | Intention-to-treat for participants with a known infant outcome at the 7th day of life. Seventy-two (72) stillbirths were removed from analysis cohort. This includes 13 participants for whom an outcome is not known at 6 weeks of life for the primary outcome. Seventy-two (72) stillbirths were removed from analysis cohort.Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth. | Posted | Count of Participants | Participants | 7 days postpartum |
|
|
|
|
| Secondary | Initiation of Early Breastfeeding | Number of participants initiating breastfeeding in 1st hour of life | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, who attended the 2 week follow-up visit, who did not decline to answer and those for whom data was not missing. | Posted | Count of Participants | Participants | 1 hour postpartum |
|
|
|
|
| Secondary | Exclusive Breastfeeding | Exclusive breastfeeding at 6-week visit | This population includes participants who did not experience a stillbirth or infant death by 6 weeks postpartum, who attended the 6 week follow-up visit, who did not decline to answer and those for whom data was not missing. | Posted | Count of Participants | Participants | 6-weeks postpartum |
|
|
|
|
| Secondary | Thermal Care | Number of participants not giving infant a bath in 1st 24 hours of life | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, whose infants did not die on the first day of life, who did not decline to answer and those for whom data was not missing. | Posted | Count of Participants | Participants | 24 hours postpartum |
|
|
|
|
| Secondary | Cord Care | Number of participants with no application of substances to cord | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, those who did not decline to answer and those for whom data was not missing. | Posted | Count of Participants | Participants | 2-weeks postpartum |
|
|
|
|
| Secondary | 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 | Only among preterm and/or low birth weight live births. | Posted | Count of Participants | Participants | 14 days at home postpartum |
|
|
|
|
| Secondary | Maternal Knowledge of Neonatal Danger Signs | Number of danger signs or symptoms successfully named | For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. Data are missing for those experienced an infant loss by the 6-week visit. | Posted | Median | Inter-Quartile Range | Number of danger signs named | Up to 6-weeks postpartum |
|
|
|
|
| Secondary | 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). | Only in infants with illness episodes with danger signs and/or where the infant was hospitalized irrespective of danger signs reported. | Posted | Count of Participants | Participants | 18 weeks postpartum |
|
|
|
|
| Secondary | 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. | This population includes participants who attended the 6 week visit, those who did not decline to answer and those for whom data was not missing. | Posted | Count of Participants | Participants | Enrollment through 6-weeks postpartum |
|
|
|
|
| Secondary | 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. | For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. | Posted | Median | Inter-Quartile Range | score on a scale | Enrollment through 6-weeks postpartum |
|
|
|
|
| Secondary | Self-efficacy | Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence. | For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. | Posted | Median | Inter-Quartile Range | score on a scale | Enrollment through 6-weeks postpartum |
|
|
|
|
| 2 |
| 2,505 |
| 171 |
| 2,505 |
| 7 |
| 2,505 |
| EG001 | No SMS Control | Control receiving standard of care. | 2 | 2,508 | 114 | 2,508 | 2 | 2,508 |
| Infant death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Deaths of live-born infants. Stillbirths and missing outcome data excluded from denominator. |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal hospitalization | General disorders | Systematic Assessment |
|
| Infant hospitalization | General disorders | Systematic Assessment | Hospitalization of live-born infants. Stillbirths excluded from denominator. |
|
| Maternal disappearance | General disorders | Systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
SMS group is the numerator
| Superiority |
| Superiority |
| Superiority |
SMS group is the numerator
| Superiority |
SMS group is the numerator
| Superiority |
| Superiority |
n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.
| Superiority |
SMS group is the numerator.
| Superiority |
n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.
| Superiority |