Grandi Byen-supporting child growth and development through integrated, responsive parenting, nutrition and hygiene: study protocol for a randomized controlled trial

Patricia L Kohl, Emmanuel A Gyimah, Jenna Diaz, F Matthew Kuhlmann, Sherlie Jean-Louis Dulience, Fithi Embaye, Derek S Brown, Shenyang Guo, Joan L Luby, Jennifer L Nicholas, Jay Turner, Melissa Chapnick, Joseline Marhone Pierre, Jacques Boncy, Rony St Fleur, Maureen M Black, Lora L Iannotti, Patricia L Kohl, Emmanuel A Gyimah, Jenna Diaz, F Matthew Kuhlmann, Sherlie Jean-Louis Dulience, Fithi Embaye, Derek S Brown, Shenyang Guo, Joan L Luby, Jennifer L Nicholas, Jay Turner, Melissa Chapnick, Joseline Marhone Pierre, Jacques Boncy, Rony St Fleur, Maureen M Black, Lora L Iannotti

Abstract

Background: Poor child growth and development outcomes stem from complex relationships encompassing biological, behavioral, social, and environmental conditions. However, there is a dearth of research on integrated approaches targeting these interwoven factors. The Grandi Byen study seeks to fill this research gap through a three-arm longitudinal randomized controlled trial which will evaluate the impact of an integrated nutrition, responsive parenting, and WASH (water, sanitation and hygiene) intervention on holistic child growth and development.

Methods: We will recruit 600 mother-infant dyads living in Cap-Haitien, Haiti and randomize them equally into one of the following groups: 1) standard well-baby care; 2) nutritional intervention (one egg per day for 6 months); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, WASH + one egg per day for 6 months). Primary outcomes include child growth as well as cognitive, language, motor, and social-emotional development. The study also assesses other indicators of child health (bone maturation, brain growth, diarrheal morbidity and allergies, dietary intake, nutrient biomarkers) along with responsive parenting as mediating factors influencing the primary outcomes. An economic evaluation will assess the feasibility of large-scale implementation of the interventions.

Discussion: This study builds on research highlighting the importance of responsive parenting interventions on overall child health, as well as evidence demonstrating that providing an egg daily to infants during the complementary feeding period can prevent stunted growth. The multicomponent Grandi Byen intervention may provide evidence of synergistic or mediating effects of an egg intervention with instruction on psychoeducational parenting and WASH on child growth and development. Grandi Byen presents key innovations with implications for the well-being of children living in poverty globally.

Trial registration: NCT04785352 . Registered March 5, 2021 at https://clinicaltrials.gov/.

Keywords: Child development; Integrated parenting intervention; Nutrition; Responsive parenting; Stunting.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Conceptual Model of Mediating Mechanisms
Fig. 2
Fig. 2
Hypothesized pathways from study conditions to outcomes
Fig. 3
Fig. 3
Cap-Haitien and surrounding communities. Map by E.A. Gyimah
Fig. 4
Fig. 4
Randomization Scheme

References

    1. Stewart CP, Iannotti L, Dewey KG, Michaelsen KF, Onyango AW. Contextualising complementary feeding in a broader framework for stunting prevention. Maternal & Child Nutrition. 2013;9:27–45.
    1. United Nations Children’s Fund, World Health Organization, World Bank Group. Levels and trends in child malnutrition: key findings of the 2020 edition. . Accessed 28 Jul 2021.
    1. FAO. IFAD. UNICEF. WFP. WHO . The state of food security and nutrition in the world 2020: transforming food systems for affordable healthy diets. Rome: FAO, IFAD, UNICEF, WFP and WHO; 2020.
    1. Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: science through the life course. Lancet. 2017;389:77–90.
    1. Jensen SKG, Berens AE, Nelson CA. Effects of poverty on interacting biological systems underlying child development. The Lancet Child & Adolescent Health. 2017;1:225–239.
    1. Luby J, Belden A, Botteron K, Marrus N, Harms MP, Babb C, et al. The effects of poverty on childhood brain development: the mediating effect of caregiving and stressful life events. JAMA Pediatrics. 2013;167:1135–1142.
    1. Black MM, Pérez-Escamilla R, Fernandez RS. Integrating nutrition and child development interventions: scientific basis, evidence of impact, and implementation considerations. Advances in Nutrition. 2015;6:852–859.
    1. Black MM, Dewey KG. Promoting equity through integrated early child development and nutrition interventions. Ann NY Acad Sci. 2014;1308:1–10.
    1. Perez-Escamilla R, Bermudez O, Buccini GS, Kumanyika S, Lutter CK, Monsivais P, et al. Nutrition disparities and the global burden of malnutrition. BMJ. 2018;361:k2252.
    1. Iannotti LL, Lutter CK, Stewart CP, Riofrío CAG, Malo C, Reinhart G, et al. Eggs in early complementary feeding and child growth: a randomized controlled trial. Pediatrics. 2017;140:e20163459. doi: 10.1542/peds.2016-3459.
    1. Iannotti LL, Lutter CK, Waters WF, Gallegos Riofrío CA, Malo C, Reinhart G, et al. Eggs early in complementary feeding increase choline pathway biomarkers and DHA: a randomized controlled trial in Ecuador. The American Journal of Clinical Nutrition. 2017;106:1482–1489.
    1. Assaf S, Juan C. Stunting and anemia in children from urban poor environments in 28 low and middle-income countries: a meta-analysis of demographic and health survey data. Nutrients. 2020;12:3539.
    1. The World Bank Group. Haiti: providing opportunities for all Haitians. Washington, D.C.: World Bank. . Accessed 5 Aug 2021.
    1. Viceisza A, Aflagah K, Simbou A, Dixita G, Koudakpo K. Poverty and malnutrition in Haiti: findings from Sud and Grand’Anse Departments. Washington DC: USAID, Reserch Technical Assistance Center; 2020.
    1. Troeger C, Forouzanfar M, Rao PC, Khalil I, Brown A, Reiner RC, et al. Estimates of global, regional, and national morbidity, mortality, and aetiologies of diarrhoeal diseases: a systematic analysis for the Global Burden of Disease Study 2015. The Lancet Infectious Diseases. 2017;17:909–948.
    1. Institut Haïtien de l’Enfance (IHE) et ICF . Haïti Enquête Mortalité, Morbidité et Utilisation des Services (EMMUS-VI) 2016-2017: Rapport de synthèse. Rockville: IHE et ICF; 2018.
    1. Niculescu MD. Encyclopedia of human nutrition. 3. Waltham: Academic Press; 2013. Choline and phosphatidylcholine; pp. 346–351.
    1. Weiser MJ, Butt CM, Mohajeri MH. Docosahexaenoic acid and cognition throughout the lifespan. Nutrients. 2016;8:99.
    1. Grantham-McGregor SM, Walker SP, Chang SM, Powell CA. Effects of early childhood supplementation with and without stimulation on later development in stunted Jamaican children. The American Journal of Clinical Nutrition. 1997;66:247–253.
    1. Iannotti LL, Chapnick M, Nicholas J, Gallegos-Riofrio CA, Moreno P, Douglas K, et al. Egg intervention effect on linear growth no longer present after two years. Maternal & Child Nutrition. 2020;16:e12925.
    1. Stewart CP, Caswell B, Iannotti L, Lutter C, Arnold CD, Chipatala R, et al. The effect of eggs on early child growth in rural Malawi: the Mazira Project randomized controlled trial. The American Journal of Clinical Nutrition. 2019;110:1026–1033.
    1. Caswell BL, Arnold CD, Lutter CK, Iannotti LL, Chipatala R, Werner ER, et al. Impacts of an egg intervention on nutrient adequacy among young Malawian children. Maternal & Child Nutrition. 2021;17:e13196.
    1. Prado EL, Maleta K, Caswell BL, George M, Oakes LM, DeBolt MC, et al. Early child development outcomes of a randomized trial providing 1 egg per day to children age 6 to 15 months in Malawi. The Journal of Nutrition. 2020;150:1933–1942.
    1. Parent J, Dallmann D, Sinclair K, Garcia M, Melgar-Quinonez H. Food security status and dietary intake among small farming families in Haiti. The FASEB Journal. 2014;28:805.6.
    1. Krasevec J, An X, Kumapley R, Bégin F, Frongillo EA. Diet quality and risk of stunting among infants and young children in low- and middle-income countries. Maternal & Child Nutrition. 2017;13:e12430.
    1. Liddle B. Urbanization and Inequality/poverty. Urban Sci. 2017;1:35.
    1. Ritchie H, Roser M. Urbanization. Oxford Martin School, University of Oxford; 2018. . Accessed 4 Oct 2021.
    1. Iannotti LL, Dulience SJL, Green J, Joseph S, François J, Anténor M-L, et al. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. The American Journal of Clinical Nutrition. 2014;99:198–208.
    1. Iannotti L, Dulience SJL, Wolff P, Cox K, Lesorogol C, Kohl P. Nutrition factors predict earlier acquisition of motor and language milestones among young children in Haiti. Acta Paediatrica. 2016;105:e406–e411.
    1. Luby JL. Poverty’s most insidious damage: the developing brain. JAMA Pediatrics. 2015;169:810–811.
    1. Blair C, Raver CC. Poverty, stress, and brain development: new directions for prevention and intervention. Acad Pediatr. 2016;16(3 Suppl):S30–S36.
    1. Prado EL, Larson LM, Cox K, Bettencourt K, Kubes JN, Shankar AH. Do effects of early life interventions on linear growth correspond to effects on neurobehavioural development? A systematic review and meta-analysis. The Lancet Global Health. 2019;7:e1398–e1413.
    1. Landry SH, Smith KE, Swank PR, L SH, Swank PR, Smith HKE. Responsive parenting: establishing early foundations for social, communication, and independent problem-solving skills. Developmental Psychology. 2006;42:627–642.
    1. Jonson-Reid M, Kohl PL, Drake B. Child and adult outcomes of chronic child maltreatment. Pediatrics. 2012;129:839–845.
    1. Seay KD, Kohl PL. Caregiver substance abuse and children’s exposure to violence in a nationally representative child welfare sample. Journal of Social Work Practice in the Addictions. 2013;13:70–90.
    1. Kohl PL, Macy RJ. Profiles of victimized women among the child welfare population: implications for targeted child welfare policy and practices. J Fam Viol. 2008;23:57–68.
    1. Chapnick M, Iannotti L, Constantino J, Jean-Louis Dulience S, McCrary S, Prewitt K, et al. Parenting for growth and development pilot: a new intervention approach in Haiti. St. Louis: Institute of Public Health 10th Annual Conference; 2017.
    1. Gollub EL, Dévieux J, Michele J-G, Pierre Ste-Rose S, Neptune S, Pelletier V. “This method, I think, can shed new light”: Haitian-American women’s reflections on risk, culture, and family planning decisions from a short-term trial of a cervical barrier (FemcapTM) Int Q Community Health Educ. 2016;36:253–263.
    1. Singla DR, Kumbakumba E, Aboud FE. Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster-randomised trial. The Lancet Global Health. 2015;3:e458–e469.
    1. Kohl PL, Seay KD. Engaging African American fathers in behavioral parent training: to adapt or not adapt. Best Pract Ment Health. 2015;11:54–68.
    1. Stahlschmidt MJ, Threlfall J, Seay KD, Lewis EM, Kohl PL. Recruiting fathers to parenting programs: advice from dads and fatherhood program providers. Children and Youth Services Review. 2013;35:1734–1741.
    1. Chiang C-J, Jonson-Reid M, Kim H, Drake B, Pons L, Kohl P, et al. Service engagement and retention: lessons from the early childhood connections program. Children and Youth Services Review. 2018;88:114–127.
    1. Jonson-Reid M, Drake B, Constantino JN, Tandon M, Pons L, Kohl P, et al. A randomized trial of home visitation for CPS-involved families: the moderating impact of maternal depression and CPS history. Child Maltreat. 2018;23:281–293.
    1. Lewis EM, Feely M, Seay KD, Fedoravicis N, Kohl PL. Child welfare involved parents and pathways triple P: perceptions of program acceptability and appropriateness. J Child Fam Stud. 2016;25:3760–3770.
    1. Feely M, Seay KD, Lanier P, Auslander W, Kohl PL. Measuring fidelity in research studies: a field guide to developing a comprehensive fidelity measurement system. Child Adolesc Soc Work J. 2018;35:139–152.
    1. Darvesh N, Das JK, Vaivada T, Gaffey MF, Rasanathan K, Bhutta ZA. Water, sanitation and hygiene interventions for acute childhood diarrhea: a systematic review to provide estimates for the lives saved tool. BMC Public Health. 2017;17(Suppl 4):776.
    1. Donowitz JR, Drew J, Taniuchi M, Platts-Mills JA, Alam M, Ferdous T, et al. Diarrheal pathogens associated with growth and neurodevelopment. Clin Infect Dis. 2021;73:e683–e691.
    1. Kotloff KL, Nasrin D, Blackwelder WC, Wu Y, Farag T, Panchalingham S, et al. The incidence, aetiology, and adverse clinical consequences of less severe diarrhoeal episodes among infants and children residing in low-income and middle-income countries: a 12-month case-control study as a follow-on to the Global Enteric Multicenter Study (GEMS) The Lancet Global Health. 2019;7:e568–e584.
    1. Rogawski ET, Liu J, Platts-Mills JA, Kabir F, Lertsethtakarn P, Siguas M, et al. Use of quantitative molecular diagnostic methods to investigate the effect of enteropathogen infections on linear growth in children in low-resource settings: longitudinal analysis of results from the MAL-ED cohort study. The Lancet Global Health. 2018;6:e1319–e1328.
    1. Watanabe K, Petri WA. Environmental enteropathy: elusive but significant subclinical abnormalities in developing countries. EBioMedicine. 2016;10:25–32.
    1. Kumar P, Kuhlmann FM, Bhullar K, Yang H, Vallance BA, Xia L, et al. Dynamic interactions of a conserved enterotoxigenic escherichia coli adhesin with intestinal mucins govern epithelium engagement and toxin delivery. Infection and Immunity. 2016;84:3608–3617.
    1. Kumar P, Kuhlmann FM, Chakraborty S, Bourgeois AL, Foulke-Abel J, Tumala B, et al. Enterotoxigenic Escherichia coli–blood group A interactions intensify diarrheal severity. J Clin Invest. 2018;128:3298–3311.
    1. Khalil IA, Troeger C, Blacker BF, Rao PC, Brown A, Atherly DE, et al. Morbidity and mortality due to shigella and enterotoxigenic Escherichia coli diarrhoea: the Global Burden of Disease Study 1990–2016. The Lancet Infectious Diseases. 2018;18:1229–1240.
    1. Felner RD, Brand S, DuBois DL, Adan AM, Mulhall PF, Evans EG. Socioeconomic disadvantage, proximal environmental experiences, and socioemotional and academic adjustment in early adolescence: investigation of a mediated effects model. Child Development. 1995;66:774–792.
    1. Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. The Lancet Global Health. 2016;4:916–922.
    1. Bentley ME, Johnson SL, Wasser H, Creed-Kanashiro H, Shroff M, Fernandez-Rao S, et al. Formative research methods for designing culturally appropriate, integrated child nutrition and development interventions: an overview. Ann N Y Acad Sci. 2014;1308:54–67.
    1. Grantham-McGregor S, Fernald L, Kagawa R, Walker S. Effects of integrated child development and nutrition interventions on child development and nutrition status. Annals of the New York Academy of Sciences. 2014;1308:11–32.
    1. Barochia AV, Cui X, Vitberg D, Suffredini AF, O’Grady NP, Banks SM, et al. Bundled care for septic shock: an analysis of clinical trials. Crit Care Med. 2010;38:668–678.
    1. Rodríguez-Baño J, García L, Ramírez E, Martínez-Martínez L, Muniain MA, Fernández-Cuenca F, et al. Long-term control of hospital-wide, endemic multidrug-resistant Acinetobacter baumannii through a comprehensive “bundle” approach. American Journal of Infection Control. 2009;37:715–722.
    1. Gallegos-Riofrío CA, Waters WF, Salvador JM, Carrasco AM, Lutter CK, Stewart CP, et al. The Lulun Project’s social marketing strategy in a trial to introduce eggs during complementary feeding in Ecuador. Maternal & Child Nutrition. 2018;14:e12700.
    1. Mazzucca S, Arredondo EM, Hoelscher DM, Haire-Joshu D, Tabak RG, Kumanyika SK, et al. Expanding implementation research to prevent chronic diseases in community settings. Annual Review of Public Health. 2021;42:135–158.
    1. Hawe P. Lessons from complex interventions to improve health. Annual Review of Public Health. 2015;36:307–323.
    1. Raghavan R. The role of economic evaluation in dissemination and implementation research. In: Brownson RC, Colditz GA, Proctor EK, editors. Dissemination and implementation research in health: translating science to practice. New York: Oxford University Press; 2012. pp. 89–106.
    1. Raudenbush SW, Liu X. Statistical power and optimal design for multisite randomized trials. Psychological Methods. 2000;5:199–213.
    1. Dallal GE. . 2020.
    1. Ministère de la Santé Publique et de la Population, Republique d’Haiti. . Accessed 25 May 2018.
    1. Cayemittes, M., Busangu, M. F., Bizimana, J. D., Barrère, B., Sévère, B., & Cayemittes V. Enquête mortalité, morbidité et utilisation des services, Haiti. 2012. Calverton; 2016.
    1. Hardcastle SJ, Hancox J, Hattar A, Maxwell-Smith C, Thøgersen-Ntoumani C, Hagger MS. Motivating the unmotivated: how can health behavior be changed in those unwilling to change? Front Psychol. 2015;6:835. doi: 10.3389/fpsyg.2015.00835.
    1. Aboud FE, Yousafzai AK. Global health and development in early childhood. Annual Review of Psychology. 2015;66:433–457.
    1. Chowdhary N, Sikander S, Atif N, Singh N, Ahmad I, Fuhr DC, et al. The content and delivery of psychological interventions for perinatal depression by non-specialist health workers in low and middle income countries: a systematic review. Best Practice and Research: Clinical Obstetrics and Gynaecology. 2014;28:113–133.
    1. Zafar S, Haq Z. Integrating maternal psychosocial well-being into a child-development intervention: the five-pillars approach. Annals of the New York Academy of Sciences. 2014;1308:107–117.
    1. World Health Organization . Training course on child growth assessment. 2006.
    1. World Health Organization (WHO). The WHO child growth standards. . Accessed 24 May 2018.
    1. Small JW, Hix-Small H, Vargas-Baron E, Marks KP. Comparative use of the ages and stages questionnaires in low- and middle-income countries. Developmental Medicine & Child Neurology. 2019;61:431–443.
    1. Squires J, Bicker D. Ages & stages questionnaires®: a parent-completed child monitoring system. 3. Baltimore: Paul H. Brookes Publishing Co.; 2009.
    1. Squires J, Bicker D, Twombly E. Ages & stages questionnaires®: social–emotional (ASQ:SE): a parent-completed child monitoring system for social–emotional behaviours. Baltimore: Paul H. Brookes Publishing Co.; 2002.
    1. Roggman LA, Cook GA, Innocenti MS, Jump Norman V, Christiansen K. Parenting interactions with children: checklist of observations linked to outcomes (PICCOLO) in diverse ethnic groups: PICCOLO paenting measure in a diverse sample. Infant Ment Health J. 2013;34:290–306.
    1. Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology. 1984;20:315–320.
    1. Totsika V, Sylva K. The home observation for measurement of the environment revisited. Child and Adolescent Mental Health. 2004;9:25–35.
    1. Gibson RS, Ferguson ES. An interactive 24-hour recall for assessing the adequacy of iron and zinc intakes in developing countries. Technical Monograph. International Food Policy Research Institute (IFPRI) and International Center for Tropical Agriculture (CIAT); 2008. .
    1. Erhardt J. Nutrition surveys and calculations: guidelines, software and additional Information. Germany.
    1. Nicholas JL, Douglas KE, Waters W, Gallegos Riofrío CA, Chapnick M, Habif DV, et al. US evaluation of bone age in rural ecuadorian children: association with anthropometry and nutrition. Radiology. 2020;296:161–169.
    1. Greulich W, Pyle S. Radiographic atlas of skeletal development of the hand and wrist. 2. California: Stanford University Press; 1959.
    1. Sibbald CA, Nicholas JL, Chapnick M, Ross N, Gandor PL, Waters WF, et al. Fetal brain ultrasound measures and maternal nutrition: a feasibility study in Ecuador. American Journal of Human Biology. 2021;33:e23467.
    1. Provenzi L, Giorda R, Beri S, Montirosso R. SLC6A4 methylation as an epigenetic marker of life adversity exposures in humans: a systematic review of literature. Neuroscience & Biobehavioral Reviews. 2016;71:7–20.
    1. Tamburini S, Shen N, Wu HC, Clemente JC. The microbiome in early life: implications for health outcomes. Nat Med. 2016;22:713–722.
    1. Bonder MJ, Kurilshikov A, Tigchelaar EF, Mujagic Z, Imhann F, Vila AV, et al. The effect of host genetics on the gut microbiome. Nat Genet. 2016;48:1407–1412.
    1. Boardman AE, Greenberg DH, Vining AR, Weimer DL. Cost-benefit analysis: concepts and practice. Cambridge: Cambridge University Press; 2017.
    1. Krull JL, MacKinnon DP. Multilevel modeling of individual and group level mediated effects. Multivar Behav Res. 2001;36(2):249–77.
    1. Guo S, Fraser MW. Propensity score analysis: statistical methods and applications. 2010.
    1. Guo S. Survival analysis. In: Bornstein MH, editor. The SAGE encyclopedia of lifespan human development. New York: SAGE Publications; 2018.
    1. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: building an international community of software platform partners. Journal of Biomedical Informatics. 2019;95:103208.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. New York: Wiley; 1987.
    1. Allison PD. Missing data. Thousand Oaks: SAGE Publications; 2002.
    1. Graham JW. Missing data analysis: making it work in the real world. Annual Review of Psychology. 2009;60:549–576.
    1. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015.
    1. Neumann PJ, Sanders GD, Russell LB, Siegel JE, Ganiats TG, editors. Cost-effectiveness in health and medicine. Oxford: Oxford University Press; 2016.
    1. Engle-Stone R, Stewart CP, Vosti SA, Adams KP. Preventative nutrition interventions: benefit-cost analysis. Haiti Priorise: Copenhagen Consensus Center; 2017.
    1. Wong B, Radin M. Benefit-cost analysis of a package of early childhood interventions to improve nutrition in Haiti. J Benefit Cost Anal. 2019;10:154–184.
    1. Murray CJL, Aravkin AY, Zheng P, Abbafati C, Abbas KM, Abbasi-Kangevari M, et al. Global burden of 87 risk factors in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. 2020;396:1223–1249.
    1. World Health Organization . Global nutrition targets 2025: stunting policy brief. Policy brief. Geneva: World Health Organization; 2014.

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