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

Keshet Ronen, Esther M Choo, Brenda Wandika, Jenna I Udren, Lusi Osborn, Peninah Kithao, Anna B Hedstrom, Millicent Masinde, Manasi Kumar, Dalton C Wamalwa, Barbra A Richardson, John Kinuthia, Jennifer A Unger, Keshet Ronen, Esther M Choo, Brenda Wandika, Jenna I Udren, Lusi Osborn, Peninah Kithao, Anna B Hedstrom, Millicent Masinde, Manasi Kumar, Dalton C Wamalwa, Barbra A Richardson, John Kinuthia, Jennifer A Unger

Abstract

Introduction: Globally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life). Kenya ranks among countries with the highest number of neonatal deaths, at 20 per 1000 live births. Improved identification and management of neonates with potentially life-threatening illness is critical to meet the WHO's target of ≤12 neonatal deaths per 1000 live births by 2035. We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health (Mobile women's and children's health (WACh) NEO), focused on the perinatal period. Mobile WACh NEO sends automated tailored SMS messages to mothers during pregnancy and up to 6 weeks post partum. Messages employ the Information-Motivation-Behaviour Skills framework to promote (1) maternal implementation of essential newborn care (ENC, including early, exclusive breast feeding, cord care and thermal care), (2) maternal identification of neonatal danger signs and care-seeking, and (3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.

Methods and analysis: We describe a two-arm unblinded randomised controlled trial of the Mobile WACh NEO intervention. We will enrol 5000 pregnant women in the third trimester of pregnancy at 4 facilities in Kenya and randomise them 1:1 to receive interactive SMS or no SMS (control), and conduct follow-up visits at 2 and 6 weeks post partum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.

Ethics and dissemination: This study received ethical approval from the University of Washington (STUDY00006395), Women and Infants Hospital (1755292-1) and Kenyatta National Hospital/University of Nairobi (P310/04/2019). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences.

Trial registration number: NCT04598165.

Keywords: depression & mood disorders; neonatology; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT diagram of Mobile WACh NEO Trial. The Mobile WACh NEO intervention is semiautomated interactive SMS during pregnancy and up to 6 weeks post partum. Recruitment and randomisation began in September 2020, in-depth interviews will begin in January 2022, and follow-up is anticipated to end in may 2023. ANC, antenatal care; CONSORT, Consolidated Standards of Reporting Trials; SMS, short messaging service; WACh, women’s and children’s health.
Figure 2
Figure 2
Messaging timing, content and tracks for Mobile WACh NEO. WACh, women’s and children’s health.
Figure 3
Figure 3
Conceptual framework for mobile WACh NEO. SMS, short messaging service; WACh, women’s and children’s health.
Figure 4
Figure 4
Screenshot of mobile WACh system study nurse interface. WACh, women’s and children’s health.

References

    1. WHO . Newborns: reducing mortality. Available: [Accessed 17 Aug 2020].
    1. UN Inter-agency Group for Child Mortality Estimation . Levels & Trends in Child Mortality, 2019. Available:
    1. Kenya National Bureau of Statistics . Kenya demographic and health survey 2014, 2015. Available:
    1. United Nations . Global indicator framework for the sustainable development goals and targets of the 2030 agenda for sustainable development. 2020. Available: [Accessed 14 Oct 2020].
    1. World Health Organizaton . Every newborn: an action plan to end preventable deaths, 2014. Available: [Accessed 14 Oct 2020].
    1. World Health Organization . Who recommendations on newborn health guidelines, 2017. Available: [Accessed 17 Aug 2020].
    1. Bhutta ZA, Darmstadt GL, Hasan BS, et al. . Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics 2005;115:519–617. 10.1542/peds.2004-1441
    1. Edmond K, Newton S, Hurt L, et al. . Timing of initiation, patterns of breastfeeding, and infant survival: prospective analysis of pooled data from three randomised trials. Lancet Glob Health 2016;4:e266–75. 10.1016/S2214-109X(16)00040-1
    1. Agrawal PK, Agrawal S, Mullany LC, et al. . Clean cord care practices and neonatal mortality: evidence from rural Uttar Pradesh, India. J Epidemiol Community Health 2012;66:755–8. 10.1136/jech-2011-200362
    1. Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol 2012;32:317–24. 10.1038/jp.2012.11
    1. Bee M, Shiroor A, Hill Z. Neonatal care practices in sub-Saharan Africa: a systematic review of quantitative and qualitative data. J Health Popul Nutr 2018;37:9. 10.1186/s41043-018-0141-5
    1. Bogale TN, Worku AG, Bikis GA, et al. . Why gone too soon? examining social determinants of neonatal deaths in Northwest Ethiopia using the three delay model approach. BMC Pediatr 2017;17:216. 10.1186/s12887-017-0967-9
    1. Källander K, Hildenwall H, Waiswa P, et al. . Delayed care seeking for fatal pneumonia in children aged under five years in Uganda: a case-series study. Bull World Health Organ 2008;86:332–8. 10.2471/BLT.07.049353
    1. Waiswa P, Kallander K, Peterson S, et al. . Using the three delays model to understand why newborn babies die in eastern Uganda. Trop Med Int Health 2010;15:964–72. 10.1111/j.1365-3156.2010.02557.x
    1. Wilmot E, Yotebieng M, Norris A, et al. . Missed opportunities in neonatal deaths in Rwanda: applying the three delays model in a cross-sectional analysis of neonatal death. Matern Child Health J 2017;21:1121–9. 10.1007/s10995-016-2210-y
    1. Thaddeus S, Maine D. Too far to walk: maternal mortality in context. Soc Sci Med 1994;38:1091–110. 10.1016/0277-9536(94)90226-7
    1. Alhusen JL, Ayres L, DePriest K. Effects of maternal mental health on engagement in favorable health practices during pregnancy. J Midwifery Womens Health 2016;61:210–6. 10.1111/jmwh.12407
    1. Grigoriadis S, VonderPorten EH, Mamisashvili L, et al. . The impact of maternal depression during pregnancy on perinatal outcomes: a systematic review and meta-analysis. J Clin Psychiatry 2013;74:e321–41. 10.4088/JCP.12r07968
    1. Jarde A, Morais M, Kingston D, et al. . Neonatal outcomes in women with untreated antenatal depression compared with women without depression: a systematic review and meta-analysis. JAMA Psychiatry 2016;73:826–37. 10.1001/jamapsychiatry.2016.0934
    1. Grote NK, Bridge JA, Gavin AR, et al. . A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry 2010;67:1012–24. 10.1001/archgenpsychiatry.2010.111
    1. Gausia K, Moran AC, Ali M, et al. . Psychological and social consequences among mothers suffering from perinatal loss: perspective from a low income country. BMC Public Health 2011;11:451. 10.1186/1471-2458-11-451
    1. Murray L, Cooper PJ, Stein A. Postnatal depression and infant development. BMJ 1991;302:978–9. 10.1136/bmj.302.6783.978
    1. Deave T, Heron J, Evans J, et al. . The impact of maternal depression in pregnancy on early child development. BJOG 2008;115:1043–51. 10.1111/j.1471-0528.2008.01752.x
    1. Huizink AC, Robles de Medina PG, Mulder EJH, et al. . Stress during pregnancy is associated with developmental outcome in infancy. J Child Psychol Psychiatry 2003;44:810–8. 10.1111/1469-7610.00166
    1. Beijers R, Jansen J, Riksen-Walraven M, et al. . Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics 2010;126:e401–9. 10.1542/peds.2009-3226
    1. Feldman R, Granat A, Pariente C, et al. . Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry 2009;48:919–27. 10.1097/CHI.0b013e3181b21651
    1. McLearn KT, Minkovitz CS, Strobino DM. The timing of maternal depressive symptoms and mothers' parenting practices with young children: implications for pediatric practice. Pediatrics 2006;118:e174–82. 10.1542/peds.2005-1551
    1. Wado YD, Afework MF, Hindin MJ. Effects of maternal pregnancy intention, depressive symptoms and social support on risk of low birth weight: a prospective study from southwestern Ethiopia. PLoS One 2014;9:e96304. 10.1371/journal.pone.0096304
    1. Kawachi I, Kennedy BP, Lochner K, et al. . Social capital, income inequality, and mortality. Am J Public Health 1997;87:1491–8. 10.2105/AJPH.87.9.1491
    1. Albanese AM, Russo GR, Geller PA. The role of parental self-efficacy in parent and child well-being: a systematic review of associated outcomes. Child Care Health Dev 2019;45:333–63. 10.1111/cch.12661
    1. Bahorski JS, Childs GD, Loan LA, et al. . Self-efficacy, infant feeding practices, and infant weight gain: an integrative review. J Child Health Care 2019;23:286–310. 10.1177/1367493518788466
    1. Leahy-Warren P, McCarthy G. Maternal parental self-efficacy in the postpartum period. Midwifery 2011;27:802–10. 10.1016/j.midw.2010.07.008
    1. Gao L-L, Chan SW-chi, Mao Q. Depression, perceived stress, and social support among first-time Chinese mothers and fathers in the postpartum period. Res Nurs Health 2009;32:50–8. 10.1002/nur.20306
    1. Leahy Warren P, Warren PL. First-time mothers: social support and confidence in infant care. J Adv Nurs 2005;50:479–88. 10.1111/j.1365-2648.2005.03425.x
    1. Government of Kenya . Kenya integrated household budget survey 2015-2016, 2018. Available: [Accessed 17 Aug 2020].
    1. Communications Authority of Kenya . ICT sector quarterly statistics report (January - March 2020), 2020. Available: [Accessed 17 Aug 2020].
    1. Kenya Ministry of Health . Standards and guidelines for mHealth systems. Report. Kenya, 2017.
    1. Kazi AM, Carmichael J-L, Hapanna GW, et al. . Assessing mobile phone access and perceptions for Texting-Based mHealth interventions among expectant mothers and child caregivers in remote regions of northern Kenya: a survey-based descriptive study. JMIR Public Health Surveill 2017;3:e5. 10.2196/publichealth.5386
    1. Lee SH, Nurmatov UB, Nwaru BI, et al. . Effectiveness of mHealth interventions for maternal, newborn and child health in low– and middle–income countries: systematic review and meta–analysis. J Glob Health 2016;6:10401. 10.7189/jogh.06.010401
    1. Mbuthia F, Reid M, Fichardt A. mHealth communication to strengthen postnatal care in rural areas: a systematic review. BMC Pregnancy Childbirth 2019;19:406. 10.1186/s12884-019-2531-0
    1. Sondaal SFV, Browne JL, Amoakoh-Coleman M, et al. . Assessing the effect of mHealth interventions in improving maternal and neonatal care in low- and middle-income countries: a systematic review. PLoS One 2016;11:e0154664. 10.1371/journal.pone.0154664
    1. Lund S, Hemed M, Nielsen BB, et al. . Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG 2012;119:1256–64. 10.1111/j.1471-0528.2012.03413.x
    1. Omole O, Ijadunola MY, Olotu E, et al. . The effect of mobile phone short message service on maternal health in south-west Nigeria. Int J Health Plann Manage 2018;33:155–70. 10.1002/hpm.2404
    1. Bangal VB, K. Borawake S, P. Gavhane S, et al. . Use of mobile phone for improvement in maternal health: a randomized control trial. Int J Reprod Contracept Obstet Gynecol 2017;6:5458. 10.18203/2320-1770.ijrcog20175260
    1. Jiang H, Li M, Wen LM, et al. . Effect of short message service on infant feeding practice: findings from a community-based study in Shanghai, China. JAMA Pediatr 2014;168:471–8. 10.1001/jamapediatrics.2014.58
    1. Unger JA, Ronen K, Perrier T, et al. . Short message service communication improves exclusive breastfeeding and early postpartum contraception in a low‐ to middle‐income country setting: a randomised trial. BJOG: Int J Obstet Gy 2018;125:1620–9. 10.1111/1471-0528.15337
    1. Harrington EK, Drake AL, Matemo D, et al. . An mHealth SMS intervention on postpartum contraceptive use among women and couples in Kenya: a randomized controlled trial. Am J Public Health 2019;109:934–41. 10.2105/AJPH.2019.305051
    1. Jones RM, Kimenju G, Subbiah S, et al. . A short message service (SMS) increases postpartum care-seeking behavior and uptake of family planning of mothers in peri-urban public facilities in Kenya. PLoS One 2020;15:e0239213. 10.1371/journal.pone.0239213
    1. Sondaal SFV, Browne JL, Amoakoh-Coleman M, et al. . Assessing the effect of mHealth interventions in improving maternal and neonatal care in low- and middle-income countries: a systematic review. PLoS One 2016;11:e0154664. 10.1371/journal.pone.0154664
    1. WHO . WHO guideline: recommendations on digital interventions for health system strengthening. World Health Organization, 2019.
    1. Zhou C, Hu H, Wang C. The effectiveness of mHealth interventions on postpartum depression: a systematic review and meta-analysis. J Telemed Telecare 2020;1357633X:2091781.
    1. Fedha T. Impact of mobile telephone on maternal health service care: a case of Njoro division. Open J Prev Med 2014;04:365–76. 10.4236/ojpm.2014.45044
    1. Lund S, Rasch V, Hemed M, et al. . Mobile phone intervention reduces perinatal mortality in Zanzibar: secondary outcomes of a cluster randomized controlled trial. JMIR Mhealth Uhealth 2014;2:e15. 10.2196/mhealth.2941
    1. Fisher WA, Fisher JD, Harman J. The information-motivation-behavioraI skills model: A general social psychological approach to understanding and promoting health behavior. In: Suls J, Wallston KA, eds. Social psychological foundations of health and illness. John Wiley & Sons, 2003: 82–106.
    1. Unger JA, Wandika B, Ronen K. Mobile WACh NEO: engagementengagement of pregnant and postpartum women with a two-way SMS service to improve neonatal outcomes. In: Pediatric academic societies meeting. Baltimore, MD, 2019.
    1. Drake AL, Unger JA, Ronen K, et al. . Evaluation of mHealth strategies to optimize adherence and efficacy of option B+ prevention of mother-to-child HIV transmission: rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials 2017;57:44–50. 10.1016/j.cct.2017.03.007
    1. Kenya Ministry of Public Health and Sanitation . National guidelines on essential newborn care. Nairobi, Kenya, 2015.
    1. Unger JA, Kinuthia J, John-Stewart G. Texting Condolences: adapting mHealth programs after unexpected pregnancy and infant outcomes. JMIR Mhealth Uhealth 2017;5:e176. 10.2196/mhealth.8303
    1. Perrier T, Dell N, DeRenzi B. Engaging pregnant women in Kenya with a hybrid computer-human SMS communication system. In: 33rd Annual ACM Conference. New York, USA: ACM Press, 2015: 1429–38.
    1. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. development of the 10-item Edinburgh postnatal depression scale. Br J Psychiatry 1987;150:782–6 10.1192/bjp.150.6.782
    1. Green EP, Tuli H, Kwobah E, et al. . Developing and validating a perinatal depression screening tool in Kenya blending Western criteria with local idioms: a mixed methods study. J Affect Disord 2018;228:49–59. 10.1016/j.jad.2017.11.027
    1. Kumar M, Ongeri L, Mathai M, et al. . Translation of EPDS questionnaire into Kiswahili: understanding the cross-cultural and translation issues in mental health research. J Pregnancy Child Health 2015;2. 10.4172/2376-127X.1000134
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med 1991;32:705–14. 10.1016/0277-9536(91)90150-B
    1. Črnčec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health 2008;31:442–53. 10.1002/nur.20271
    1. Murray CJ, Lopez AD, Black R, et al. . Population health metrics research Consortium gold standard verbal autopsy validation study: design, implementation, and development of analysis datasets. Popul Health Metr 2011;9:27. 10.1186/1478-7954-9-27
    1. Waiswa P, Peterson S, Tomson G, et al. . Poor newborn care practices - a population based survey in eastern Uganda. BMC Pregnancy Childbirth 2010;10:9. 10.1186/1471-2393-10-9
    1. Osborn L, Ronen K, Larsen AM. Antenatal depressive symptoms in Kenyan women living with HIV: contributions of recent HIV diagnosis, stigma, and partner violence. AIDS Care 2021:9. 10.1080/09540121.2021.1981216
    1. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. Journal of the Royal Statistical Society: Series B 1995;57:289–300. 10.1111/j.2517-6161.1995.tb02031.x
    1. Kenya Ministry of Health . COVID19 RMNH guidelines: a Kenya practical guide for continuity of reproductive, maternal, newborn and family planning care and services in the background of COVID19 pandemic. Kenya, 2020: 1–23.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa