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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.
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.
Age
14 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Ahero Sub-District Hospital
Ahero, Kisumu County, 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
Start Date
September 7, 2020
Primary Completion Date
February 20, 2023
Completion Date
February 20, 2023
Last Updated
August 15, 2024
5,020
ACTUAL participants
Interactive two-way SMS dialogue
BEHAVIORAL
Lead Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
NCT07360600
NCT06793397
Data Source & Attribution
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