The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for school-age follow-up [version 1; peer review: 2 approved]
oleh: Virginia Sauramba, Kuda Mutasa, SHINE Follow-up Trial team, Jean H. Humphrey, Clever Mazhanga, Joseph D. Piper, Idah Mapurisa, Gloria Mapako, Eunice Munyama, Tsitsi Mashedze, Dzivaidzo Chidhanguro, Marian Mwapaura, Naume V. Tavengwa, Lisa F. Langhaug, Robert Ntozini, Melanie Smuk, Elizabeth Allen, Andrew J. Prendergast, Maria Kuona, Kundai Sibanda, Thombizodwa Mashiri, Monica Tichagwa, Dzidzai Matemavi, Asinje Saidi, Soneni Nyoni, Eddington Mpofu, Manasa Mangwende, Batsirai Mutasa, Joice Tome, Laura E. Smith, Bernard Chasekwa, Melissa J. Gladstone, Jonathan C. Wells, Handrea Njovo, Mary Muchekeza, Chandiwana Nyachowe
| Format: | Article |
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| Diterbitkan: | Wellcome 2023-07-01 |
Deskripsi
Background: There is a need for follow-up of early-life stunting intervention trials into childhood to determine their long-term impact. A holistic school-age assessment of health, growth, physical and cognitive function will help to comprehensively characterise the sustained effects of early-life interventions. Methods: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe assessed the effects of improved infant and young child feeding (IYCF) and/or improved water, sanitation and hygiene (WASH) on stunting and anaemia at 18 months. Among children enrolled to SHINE, 1,275 have been followed up at 7-8 years of age (1,000 children who have not been exposed to HIV, 268 exposed to HIV antenatally who remain HIV negative and 7 HIV positive children). Children were assessed using the School-Age Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox, to measure their growth, body composition, cognitive and physical function. In parallel, a caregiver questionnaire assessed household demographics, socioeconomic status, adversity, nurturing, caregiver support, food and water insecurity. A monthly morbidity questionnaire is currently being administered by community health workers to evaluate school-age rates of infection and healthcare-seeking. The impact of the SHINE IYCF and WASH interventions, the early-life ‘exposome’, maternal HIV, and contemporary exposures on each school-age outcome will be assessed. We will also undertake an exploratory factor analysis to generate new, simpler metrics for assessment of cognition (COG-SAHARAN), growth (GROW-SAHARAN) and combined growth, cognitive and physical function (SUB-SAHARAN). The SUB-SAHARAN toolbox will be used to conduct annual assessments within the SHINE cohort from ages 8-12 years. Ethics and dissemination: Approval was obtained from Medical Research Council of Zimbabwe (08/02/21) and registered with Pan-African Clinical Trials Registry (PACTR202201828512110, 24/01/22). Primary caregivers provided written informed consent and children written assent. Findings will be disseminated through community sensitisation, peer-reviewed journals and stakeholders including the Zimbabwean Ministry of Health and Child Care.