The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial

Allison I Daniel, Meta van den Heuvel, Wieger P Voskuijl, Melissa Gladstone, Mike Bwanali, Isabel Potani, Celine Bourdon, Jenala Njirammadzi, Robert H J Bandsma, Allison I Daniel, Meta van den Heuvel, Wieger P Voskuijl, Melissa Gladstone, Mike Bwanali, Isabel Potani, Celine Bourdon, Jenala Njirammadzi, Robert H J Bandsma

Abstract

Background: Severe acute malnutrition (SAM) is associated with high mortality rates and impairments in growth and development in children that do survive. There are complex nutritional, health, and behavioural risk factors involving severely malnourished children and their primary caregivers, requiring integrated intervention approaches.

Methods: A cluster-randomized controlled trial at the Queen Elizabeth Central Hospital in Blantyre, Malawi will be conducted to evaluate the effectiveness of a 4-day hospital-based intervention programme directed at primary caregivers. This programme, titled the Kusamala Program, aims to improve developmental and nutritional outcomes in children with SAM. Up to six primary caregivers and their children will be enrolled to groups each week, which will be randomly allocated to intervention or comparison arms. The intervention package consists of interactive counselling on three modules: 1) nutrition and feeding; 2) water, sanitation, and hygiene (WASH); and 3) psychosocial stimulation. Data collection will be performed at enrolment, at discharge from hospital, and at 6 months following discharge. The primary outcome is child development assessed with the Malawi Developmental Assessment Tool (MDAT), a validated measure of gross and fine motor, language, and social development.

Discussion: This intervention programme is unique because it utilizes primary caregivers' time spent in-hospital while children receive treatment for SAM. The programme has the potential to be effective in addressing multiple aspects of child, nutrition and development.

Trial registration: ClinicalTrials.gov, NCT03072433 . Registered on 7 March 2017.

Keywords: Child development; Nutrition; Psychosocial stimulation; RCT; Severe acute malnutrition; WASH.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval for this study was obtained from the College of Medicine Research and Ethics Committee (P.04/16/1930) in Blantyre, Malawi, and the Research Ethics Board (1000053578) at the Hospital for Sick Children in Toronto, Canada. Consent will be requested of all participants in the study; primary caregivers will be asked to provide consent on behalf of themselves and their children.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Timeline of enrolment, intervention and comparison, and assessments
Fig. 2
Fig. 2
Modified version of the CONSORT 2010 flow diagram

References

    1. Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, De Onis M, Ezzati M, Grantham-Mcgregor S, Katz J, Martorell R, Uauy R. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013;382:427–51. doi: 10.1016/S0140-6736(13)60937-X.
    1. World Health Organization. WHO child growth standards and the identification of severe acute malnutrition in infants and children. Geneva: World Health Organization. 2009. Available: . Accessed 31 July 2017.
    1. Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008;371:340–57. doi: 10.1016/S0140-6736(07)61692-4.
    1. Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13(Suppl 3):S23. doi: 10.1186/1471-2458-13-S3-S23.
    1. Fergusson P, Chinkhumba J, Grijalva-Eternod C, Banda T, Mkangama C, Tomkins A. Nutritional recovery in HIV-infected and HIV-uninfected children with severe acute malnutrition. Arch Dis Child. 2009;94:512–6. doi: 10.1136/adc.2008.142646.
    1. Prado EL, Dewey KG. Nutrition and brain development in early life. Nutr Rev. 2014;72:267–84. doi: 10.1111/nure.12102.
    1. Collins S. Treating severe acute malnutrition seriously. Arch Dis Child. 2007;92:453–61. doi: 10.1136/adc.2006.098327.
    1. Kerac M, Bunn J, Chagaluka G, Bahwere P, Tomkins A, Collins S, Seal A. Follow-up of post-discharge growth and mortality after treatment for severe acute malnutrition (FuSAM study): a prospective cohort study. PLoS One. 2014;9:1–14.
    1. Grantham-McGregor S, Powell C, Walker S, Chang S, Fletcher P. The long-term follow-up of severely malnourished children who participated in an intervention program. Child Dev. 1994;65(2 Spec No):428–39. doi: 10.2307/1131394.
    1. Grantham-McGregor SM, Fernald LC, Sethuraman K. Effects of health and nutrition on cognitive and behavioural development in children in the first three years of life. Part 1: low birthweight, breastfeeding, and protein-energy malnutrition. Food Nutr Bull. 1999;20:53–75.
    1. Aboud FE, Yousafzai AK. Global health and development in early childhood. Annu Rev Psychol. 2015;66:433–57. doi: 10.1146/annurev-psych-010814-015128.
    1. Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007;369:60–70. doi: 10.1016/S0140-6736(07)60032-4.
    1. Daniel AI, Bandsma RH, Lytvyn L, Voskuijl WP, Potani I, van den Heuvel M. Psychosocial stimulation interventions for children with severe acute malnutrition: a systematic review. J Glob Health. 2017;7(1):1–714.
    1. Collins S, Dent N, Binns P, Bahwere P, Sadler K, Hallam A. Management of severe acute malnutrition in children. Lancet. 2006;368(9551):1992–2000.
    1. Ashworth A, Khanum S, Jackson A, Schofield C. Guidelines for the inpatient treatment of severely malnourished children. Geneva: World Health Organization; 2003. Available: . Acessed 31 July 2017.
    1. Kerac M, Mcgrath M, Grijalva-Eternod C, Bizouerne C, Saxton J, Bailey H, Wilkinson C, Hirsch J, Blencowe H, Shoham J, Seal A. Management of Acute Malnutrition in Infants (MAMI) Project Technical Review: current evidence, policies, practices & programme outcomes. 2010. Available: . Accessed 31 July 2017.
    1. Nahar B, Hamadani J, Ahmed T, Tofail F, Rahman A, Huda S, Grantham-McGregor S. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009;63:725–31. doi: 10.1038/ejcn.2008.44.
    1. Walker SP, Wachs TD, Gardner JM, Lozoff B, Wasserman GA, Pollitt E, Carter JA. Child development: risk factors for adverse outcomes in developing countries. Lancet. 2007;369:145–57. doi: 10.1016/S0140-6736(07)60076-2.
    1. Ngure FM, Reid BM, Humphrey JH, Mbuya MN, Pelto G, Stoltzfus RJ. Water, sanitation, and hygiene (WASH), environmental enteropathy, nutrition, and early child development: making the links. Ann N Y Acad Sci. 2014;1308:118–28. doi: 10.1111/nyas.12330.
    1. Humphrey JH. Child undernutrition, tropical enteropathy, toilets, and handwashing. Lancet. 2009;374:1032–5. doi: 10.1016/S0140-6736(09)60950-8.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.
    1. Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13:217–24.
    1. Gladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, Smyth RL. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS Med. 2010;7:1–14.
    1. World Health Organization. Guideline: updates on the management of severe acute malnutrition in infants and children. Geneva: World Health Organization; 2013. Available: . Accessed 31 July 2017.
    1. Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990;9:65–71.
    1. Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial. Trials. 2015;16(303):1–7.
    1. UNICEF, URC/CHS. Community IYCF Counselling Package. 2012. Available: . Accessed 31 July 2017.
    1. UNICEF. Water, Sanitation and Hygiene for Schoolchildren in Emergencies. 2011. Available: . Accessed 31 July 2017.
    1. World Health Organization. Care for Child Development Package. Geneva: World Health Organization; 2012. Available: . Accessed 31 July 2017.
    1. Briscoe C, Aboud F. Behaviour change communication targeting four health behaviours in developing countries: a review of change techniques. Soc Sci Med. 2012;75:612–21.
    1. Macías YF. Guidelines for Assessing Nutrition-Related Knowledge, Attitudes and Practices. Rome: Food and Agriculture Organization of the United Nations; 2014. Available: . Accessed 31 July 2017.
    1. WHO Multicentre Growth Reference Study Group. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. Geneva: World Health Organization; 2006. Available: . Accessed 31 July 2017.
    1. World Health Organization, UNICEF, USAID, AED, UC Davis, IFPRI. Indicators for assessing infant and young child feeding practices. Part II: measurement. Geneva: World Health Organization; 2010. Available: . Accessed 31 July 2017.
    1. Engle PL, Black MM, Behrman JR, de Mello Cabral M, Gertler PJ, Kapiriri L, Martorell R, Young ME, International Child Development Steering Group Strategies to avoid the loss of developmental potential in more than 200 million children in the developing world. Lancet. 2007;369:229–42. doi: 10.1016/S0140-6736(07)60112-3.
    1. World Health Organization. A user’s guide to the Self Reporting Questionnaire (SRQ). Geneva: World Health Organization; 1994. Available: . Accessed 31 July 2017.
    1. Stewart RC, Kauye F, Umar E, Vokhiwa M, Bunn J, Fitzgerald M, Tomenson B, Rahman A, Creed F. Validation of a Chichewa version of the Self-Reporting Questionnaire (SRQ) as a brief screening measure for maternal depressive disorder in Malawi. Africa J Affect Disord. 2009;112:126–34. doi: 10.1016/j.jad.2008.04.001.
    1. Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Dev Psychol. 1984;20:315–20. doi: 10.1037/0012-1649.20.2.315.
    1. van den Heuvel M, Voskuijl W, Chidzalo K, Kerac M, Reijneveld S, Bandsma R, Gladstone M. Developmental and behavioral problems in children with severe acute malnutrition (SAM) in Malawi: a cross-sectional study. J Glob Health. 2017.
    1. Sullivan GM, Feinn R. Using effect size—or why the P value is not enough. J Grad Med Educ. 2012;4:279–82. doi: 10.4300/JGME-D-12-00156.1.
    1. Cohen J. Statistical power analysis for the behavioral sciences. New York: L. Erlbaum Associates; 2017.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(18):1–9.
    1. StataCorp. Stata Statistical Software: Release 14. College Station: StataCorp LP; 2015.
    1. World Health Organization. WHO Anthro v3.2.2. Geneva: World Health Organization; 2011.
    1. R Core Team. R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2016.
    1. Tabachnick BG, Fidell LS. Using multivariate statistics. Needham Heights: Pearson/Allyn & Bacon; 2007.
    1. United Nations. Sustainable Development Goals 2015. Available: . Accessed 31 July 2017.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera