Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: the KaziAfya cluster randomised controlled trial protocol with a 2 × 2 factorial design

Abstract

Background:In low-and middle-income countries, infectious diseases remain a key public health issue. Additionally, non-communicable diseases are a rapidly growing public health problem that impose a considerable burden on population health. One way to address this dual disease burden, is to incorporate (lifestyle) health promotion measures within the education sector. In the planned study, we will (i) assess and compare physical activity, physical fitness, micronutrient status, body composition, infections with soil-transmitted helminths, Schistosoma mansoni, malaria, inflammatory and cardiovascular health risk markers, cognitive function, healthrelated quality of life, and sleep in schoolchildren in Côte d'Ivoire, South Africa and Tanzania. We will (ii) determine the bi-and multivariate associations between these variables and (iii) examine the effects of a school-based health intervention that consists of physical activity, multi-micronutrient supplementation, or both. Methods: Assuming that no interaction occurs between the two interventions (physical activity and multimicronutrient supplementation), the study is designed as a cluster-randomised, placebo-controlled trial with a 2 × 2 factorial design. Data will be obtained at three time points: at baseline and at 9 months and 21 months after the baseline assessment. In each country, 1320 primary schoolchildren from grades 1-4 will be recruited. In each school, classes will be randomly assigned to one of four interventions: (i) physical activity; (ii) multi-micronutrient supplementation; (iii) physical activity plus multi-micronutrient supplementation; and (iv) no intervention, which will serve as the control. A placebo product will be given to all children who do not receive multi-micronutrient supplementation. After obtaining written informed consent from the parents/guardians, the children will be (Continued on next page)

Prevalence of Stunting and Relationship between Stunting and Associated Risk Factors with Academic Achievement and Cognitive Function: A Cross-Sectional Study with South African Primary School Children

“…The KaziAfya study is a cluster randomized controlled trial with a 2 × 2 factorial design taking place in three African countries (Côte d’Ivoire, Tanzania, and South Africa) with a physical and multi-micronutrient intervention. Based on a-priori power analysis (for more details see [ 29 ]), we intended to recruit 1320 children in each country.…”

Physical Activity, Cardiorespiratory Fitness and Clustered Cardiovascular Risk in South African Primary Schoolchildren from Disadvantaged Communities: A Cross-Sectional Study

“…This paper draws on cross-sectional baseline data of the KaziAfya study, a cluster randomized controlled trial with a 2 × 2 factorial design. The aim of the KaziAfya study was to assess the effect of a PA and multimicronutrient supplementation intervention on children’s growth, health and wellbeing in three African countries [ 22 ]. For the South African component of the study, our intention was to recruit approximately 1320 school-aged children attending grades 1–4.…”

“…Permission was also sought from the Eastern Cape Department of Education and Department of Health, South Africa. The KaziAfya study has been registered in the ISRCTN registry ( (accessed on 9 August 2018) and was conducted in line with the study protocol [ 22 ], the principles of the Declaration of Helsinki and the guidelines of Good Clinical Practice (GCP) issued by the International Conference of Harmonisation (ICH).…”

“…Permission was also sought from the Eastern Cape Department of Education and Department of Health, South Africa. The KaziAfya study has been registered in the ISRCTN registry ( (9 August 2018)) and was conducted in line with the study protocol [ 22 ].…”

Home gardening improves dietary diversity, a cluster‐randomized controlled trial among Tanzanian women

“…The primary outcome for the trial was dietary diversity, prespecified in the ClinicalTrials.gov registration, while the secondary outcome food security was added post hoc. Dietary diversity was measured as the number of food groups consumed out of 10 using a locally adapted food frequency questionnaire (FFQ) that has been tested for validity (Zack et al, 2018) and used in previous trials (Bliznashka et al, 2020;Gerber et al, 2020). Participants were asked the average frequency of consumption of a given food item over the past 30 days using options '0 times in a month, '1-3 times per month' , '1 time per week', '2-4 times per week', '5-6 times per week', '1 time per day', '2-3 times per day', '4-5 times per day' and '6+ times per day' .…”