Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
- Conditions
- Neonatal DeathPerinatal DeathDepression
- Interventions
- Behavioral: Interactive two-way SMS dialogue
- Registration Number
- NCT04598165
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5020
- 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
- Currently enrolled in another research study
- Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interactive two-way SMS dialogue 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.
- Primary Outcome Measures
Name Time Method Neonatal Mortality 28 days postpartum Death during 1st 28 days of life
- Secondary Outcome Measures
Name Time Method Initiation of Early Breastfeeding 1 hour postpartum Number of participants initiating breastfeeding in 1st hour of life
Exclusive Breastfeeding 6-weeks postpartum Exclusive breastfeeding at 6-week visit
Thermal Care 24 hours postpartum Number of participants not giving infant a bath in 1st 24 hours of life
Cord Care 2-weeks postpartum Number of participants with no application of substances to cord
Social Support Enrollment through 6-weeks postpartum Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-100, with a higher score indicating higher levels of social support.
Self-efficacy Enrollment through 6-weeks postpartum Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.
Early Neonatal Mortality 7 days postpartum Death during 1st 7 days of life
Home Provision of Kangaroo Mother Care 14 days at home postpartum 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
Maternal Knowledge of Neonatal Danger Signs Up to 6-weeks postpartum Number of danger signs or symptoms successfully named
Appropriate Care-seeking 18 weeks postpartum 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).
Elevated Depressive Symptoms Enrollment through 6-weeks postpartum 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.
Trial Locations
- Locations (6)
Rachuonyo County Hospital
🇰🇪Homa Bay, Kenya
Bondo Sub-County Referral Hospital
🇰🇪Bondo, Kenya
Ahero Sub-District Hospital
🇰🇪Ahero, Kisumu, Kenya
Kisumu County Hospital
🇰🇪Kisumu, Kenya
Mathare North Health Centre
🇰🇪Nairobi, Kenya
Riruta Health Center
🇰🇪Nairobi, Kenya