Child Health, Agriculture and Integrated Nutrition (CHAIN): protocol for a randomised controlled trial of improved infant and young child feeding in rural Zimbabwe.
Child Health, Agriculture and Integrated Nutrition (CHAIN): protocol for a randomised controlled trial of improved infant and young child feeding in rural Zimbabwe.
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DOI：
10.1136/bmjopen-2021-056435
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发表时间：
2022-12-30
期刊：
影响因子：
2.9
通讯作者：
Prendergast, Andrew
中科院分区：
文献类型：
--
作者：
Smith, Laura E.;Chagwena, Dexter T.;Bourke, Claire;Robertson, Ruairi;Fernando, Shamiso;Tavengwa, Naume, V;Cairns, Jill;Ndhlela, Thokozile;Matumbu, Exhibit;Brown, Tim;Datta, Kavita;Mutasa, Batsirai;Tengende, Alice;Chidhanguro, Dzivaidzo;Langhaug, Lisa;Makanza, Maggie;Chasekwa, Bernard;Mutasa, Kuda;Swann, Jonathan;Kelly, Paul;Ntozini, Robert;Prendergast, Andrew
撒哈拉以南非洲地区超过四分之一的儿童发育迟缓；然而，商业补充剂只能部分满足儿童的营养需求，无法可持续生产，并且不能解决充足营养的生理障碍（例如炎症、微生物群失调和代谢功能障碍）。使用当地可获得的食物重新设计当前的婴幼儿喂养（IYCF）干预措施，以改善营养物质的摄入、吸收和利用，可以改善潜在的致病途径，并在辅食喂养的关键时期改善婴儿的生长，从而减轻全球发育迟缓的负担。儿童健康农业综合营养是一项开放标签、个体家庭随机试验，比较 IYCF 与“IYCF+”对婴儿期营养摄入的影响。 IYCF 干预措施包括社区卫生工作者提供的促进婴儿营养的行为改变模块，以及 6 至 12 个月大的小量脂质营养补充剂，此前该补充剂可将津巴布韦农村地区 18 个月大的发育迟缓率降低约 20%。 “IYCF-plus”干预措施提供了这些成分以及 NUA-45 生物强化糖豆粉、全蛋粉、辣木叶粉和维生素原 A 玉米。该试验将在津巴布韦舒鲁格维地区招募 192 名 5 至 6 个月大的婴儿。研究护士将收集基线（5-6 个月大）和终点（9-11 个月大）的数据以及血液、尿液和粪便样本。主要结果是能量摄入量，通过 9-11 个月龄时的多次 24 小时饮食回忆来测量。次要结果包括营养摄入、人体测量和血红蛋白浓度。嵌套实验室子研究将评估肠道微生物组、环境肠道功能障碍、代谢表型和先天免疫功能。定性子研究将探讨 IYCF+ 干预措施在参与者和社区利益相关者中的可接受性和可行性，以及移民对粮食生产和消费的影响。该试验在 ClinicalTrials.gov (NCT04874688) 上注册，并获得津巴布韦医学研究委员会 (MRCZ/A/2679) 的批准，经过额外修订后，最终版本 1.4 于 2021 年 8 月 20 日获得批准。试验结果的传播将通过研究区的社区参与咨询委员会和国家级平台进行。 NCT04874688。
Over one-quarter of children in sub-Saharan Africa are stunted; however, commercial supplements only partially meet child nutrient requirements, cannot be sustainably produced, and do not resolve physiological barriers to adequate nutrition (eg, inflammation, microbiome dysbiosis and metabolic dysfunction). Redesigning current infant and young child feeding (IYCF) interventions using locally available foods to improve intake, uptake and utilisation of nutrients could ameliorate underlying pathogenic pathways and improve infant growth during the critical period of complementary feeding, to reduce the global burden of stunting. Child Health Agriculture Integrated Nutrition is an open-label, individual household randomised trial comparing the effects of IYCF versus ‘IYCF-plus’ on nutrient intake during infancy. The IYCF intervention comprises behaviour change modules to promote infant nutrition delivered by community health workers, plus small-quantity lipid-based nutrient supplements from 6 to 12 months of age which previously reduced stunting at 18 months of age by ~20% in rural Zimbabwe. The ‘IYCF-plus’ intervention provides these components plus powdered NUA-45 biofortified sugar beans, whole egg powder, moringa leaf powder and provitamin A maize. The trial will enrol 192 infants between 5 and 6 months of age in Shurugwi district, Zimbabwe. Research nurses will collect data plus blood, urine and stool samples at baseline (5–6 months of age) and endline (9–11 months of age). The primary outcome is energy intake, measured by multipass 24-hour dietary recall at 9–11 months of age. Secondary outcomes include nutrient intake, anthropometry and haemoglobin concentration. Nested laboratory substudies will evaluate the gut microbiome, environmental enteric dysfunction, metabolic phenotypes and innate immune function. Qualitative substudies will explore the acceptability and feasibility of the IYCF-plus intervention among participants and community stakeholders, and the effects of migration on food production and consumption. This trial is registered at ClinicalTrials.gov (NCT04874688) and was approved by the Medical Research Council of Zimbabwe (MRCZ/A/2679) with the final version 1.4 approved on 20 August 2021, following additional amendments. Dissemination of trial results will be conducted through the Community Engagement Advisory Board in the study district and through national-level platforms. NCT04874688.
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影响因子：
3.6
作者：
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通讯作者：
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DOI：
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作者：
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通讯作者：
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影响因子：
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作者：
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