Depression Clinical Trial
Official title:
Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya
Verified date | January 2024 |
Source | Women and Infants Hospital of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5020 |
Est. completion date | February 20, 2023 |
Est. primary completion date | February 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Kenya | Ahero Sub-District Hospital | Ahero | Kisumu |
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 |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital |
Kenya,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal mortality | Death during 1st 28 days of life | 28 days postpartum | |
Secondary | Early neonatal mortality | Death during 1st 7 days of life | 7 days postpartum | |
Secondary | Initiation of early breastfeeding | Number of participants initiating breastfeeding in 1st hour of life | 1 hour postpartum | |
Secondary | Exclusive breastfeeding | Cessation of exclusive breastfeeding in 1st 6 weeks of life | 6-weeks postpartum | |
Secondary | Thermal care | Number of participants giving infant a bath in 1st 24 hours of life | 24 hours 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 | 14 days at home postpartum | |
Secondary | Cord care | Number of participants with no application of substances to cord | 2-weeks postpartum | |
Secondary | Maternal knowledge of neonatal danger signs | Number of danger signs or symptoms successfully named | 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). | 18 weeks postpartum | |
Secondary | Depression | 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 | |
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. | 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. | Enrollment through 6-weeks postpartum |
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