Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.
Institut National de la Jeunesse et des Sports, Abidjan, Côte d'Ivoire.
Trials. 2020 Jan 6;21(1):22. doi: 10.1186/s13063-019-3883-5.
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, health-related 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.
Assuming that no interaction occurs between the two interventions (physical activity and multi-micronutrient 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 subjected to anthropometric, clinical, parasitological and physiological assessments. Additionally, fitness tests will be performed, and children will be invited to wear an accelerometer device for 7 days to objectively assess their physical activity. Children infected with S. mansoni and soil-transmitted helminths will receive deworming drugs according to national policies. Health and nutrition education will be provided to the whole study population independently of the study arm allocation.
The study builds on the experience and lessons of a previous study conducted in South Africa. It involves three African countries with different social-ecological contexts to investigate whether results are generalisable across the continent.
The study was registered on August 9, 2018, with ISRCTN. https://doi.org/10.1186/ISRCTN29534081.
在中低收入国家，传染病仍然是一个主要的公共卫生问题。此外，非传染性疾病也是一个迅速增长的公共卫生问题，给人口健康带来了相当大的负担。解决这双重疾病负担的方法之一是在教育部门纳入（生活方式）健康促进措施。在计划中的研究中，我们将：（i）评估和比较科特迪瓦、南非和坦桑尼亚的学童的身体活动、身体素质、微量营养素状况、身体成分、土壤传播性蠕虫感染、曼氏血吸虫、疟疾、炎症和心血管健康风险标志物、认知功能、健康相关生活质量和睡眠；（ii）确定这些变量之间的双变量和多变量关联；（iii）研究基于学校的健康干预措施的效果，该措施包括身体活动、多种微量营养素补充剂或两者兼有。
假设两种干预措施（身体活动和多种微量营养素补充剂）之间没有相互作用，该研究设计为具有 2×2 析因设计的集群随机对照试验。数据将在三个时间点获得：基线时以及基线评估后 9 个月和 21 个月。在每个国家，将从 1-4 年级招募 1320 名小学生。在每所学校，班级将被随机分配到以下四种干预措施之一：（i）身体活动；（ii）多种微量营养素补充剂；（iii）身体活动加多种微量营养素补充剂；（iv）无干预，作为对照。所有未接受多种微量营养素补充剂的儿童将给予安慰剂产品。在获得父母/监护人的书面知情同意后，将对儿童进行人体测量学、临床、寄生虫学和生理学评估。此外，还将进行体能测试，并邀请儿童佩戴加速度计设备 7 天，以客观评估他们的身体活动。感染曼氏血吸虫和土壤传播性蠕虫的儿童将根据国家政策服用驱虫药物。将向整个研究人群提供健康和营养教育，而不论研究臂的分配如何。
该研究基于在南非进行的先前研究的经验和教训。它涉及三个具有不同社会生态背景的非洲国家，以调查结果是否在整个非洲大陆具有普遍性。
该研究于 2018 年 8 月 9 日在 ISRCTN 上注册。https://doi.org/10.1186/ISRCTN29534081。
