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Completed

NCT Number: NCT04598165

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

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.

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Key information

Conditions

Neonatal Death Behavior Behavioral Symptoms Death Depression Female Urogenital Diseases and Pregnancy Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahero Sub-District Hospital, Ahero, Kisumu County, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Neonatal Mortality

    Time frame: 28 days postpartum

    Death during 1st 28 days of life

Secondary outcomes

  1. Early Neonatal Mortality

    Time frame: 7 days postpartum

    Death during 1st 7 days of life

  2. Initiation of Early Breastfeeding

    Time frame: 1 hour postpartum

    Number of participants initiating breastfeeding in 1st hour of life

  3. Exclusive Breastfeeding

    Time frame: 6-weeks postpartum

    Exclusive breastfeeding at 6-week visit

  4. Thermal Care

    Time frame: 24 hours postpartum

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

  5. Cord Care

    Time frame: 2-weeks postpartum

    Number of participants with no application of substances to cord

  6. Home Provision of Kangaroo Mother Care

    Time frame: 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

  7. Maternal Knowledge of Neonatal Danger Signs

    Time frame: Up to 6-weeks postpartum

    Number of danger signs or symptoms successfully named

  8. Appropriate Care-seeking

    Time frame: 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).

  9. Elevated Depressive Symptoms

    Time frame: 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.

  10. Social Support

    Time frame: 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.

  11. Self-efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kenyatta National Hospital

Registry information

Official study title

Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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