Clinical trial NCT04598165: Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
Official title: Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Death
Perinatal Death
Depression
Keywords: SMS
mHealth
neonate
mortality
depression
Kenya
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Kenyatta National Hospital
First posted: 2020-10-22
Enrollment: 5020
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to 1) Interactive two-way SMS dialogue or 2) Control (no SMS), using 1:1 allocation.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Neonatal Mortality
timeFrame: 28 days postpartum
Secondary outcomes:
measure: Early Neonatal Mortality
timeFrame: 7 days postpartum
measure: Initiation of Early Breastfeeding
timeFrame: 1 hour postpartum
measure: Exclusive Breastfeeding
timeFrame: 6-weeks postpartum
measure: Thermal Care
timeFrame: 24 hours postpartum
measure: Cord Care
timeFrame: 2-weeks postpartum
measure: Home Provision of Kangaroo Mother Care
timeFrame: 14 days at home postpartum
measure: Maternal Knowledge of Neonatal Danger Signs
timeFrame: Up to 6-weeks postpartum
measure: Appropriate Care-seeking
timeFrame: 18 weeks postpartum
measure: Elevated Depressive Symptoms
timeFrame: Enrollment through 6-weeks postpartum
measure: Social Support
timeFrame: Enrollment through 6-weeks postpartum
measure: Self-efficacy
timeFrame: Enrollment through 6-weeks postpartum
Other outcomes:
Locations:
city: Ahero
country: Kenya
facility: Ahero Sub-District Hospital
state: Kisumu
city: Bondo
country: Kenya
facility: Bondo Sub-County Referral Hospital
city: Homa Bay
country: Kenya
facility: Rachuonyo County Hospital
city: Kisumu
country: Kenya
facility: Kisumu County Hospital
city: Nairobi
country: Kenya
facility: Mathare North Health Centre
city: Nairobi
country: Kenya
facility: Riruta Health Center
Study officials:
affiliation: Brown University
name: Jennifer A Unger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta National Hospital
name: John Kinuthia, MBChB, MMed
role: STUDY_DIRECTOR
References:
citation: 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.