Community Health Department, University of Ghana Medical School, Korle-Bu, Accra, Ghana.
Public Health Department, Tamale Teaching Hospital, Tamale, Ghana.
PLoS One. 2022 Apr 21;17(4):e0266157. doi: 10.1371/journal.pone.0266157. eCollection 2022.
Anaemia in children under five years remains a significant cause of mortality and morbidity in low-middle income countries. Globally, 27% of the world's population is anaemic, of which developing countries account for more than 89%. The global prevalence is worse in Africa and Asia. Anaemia has the potential of maintaining the cycle of poverty, as it prevents children from attaining their full development potential. An important part of anaemia in children under-five years are preventable. Locally available dietary (LAD) interventions may be the sustainable interventions to address the high prevalence of anaemia in our communities. The aim of the study is to determine the effect of counselling on Locally Available Diet, on anaemia among children aged 6-59 months in the Kumbungu District of the Northern Region, Ghana. This study will be a community-based cluster randomized, controlled trial, with two parallel arms; Iron + Folic Acid (IFA arm) hereby referred to as the Standard care arm and Iron + Folic Acid + Counselling on Locally available dietary intervention (IFA+LAD arm) referred to as the Standard Plus arm. Study participants are children between the ages of 6 to 56 months. All study participants would receive iron plus folic acid. The minimum number of children per arm is 330 and the number of community clusters is 10 (5 per study arm). Also, considering this study proposes two parallel arms, the total minimum study sample size of children under five years is 496, the minimum total number of community clusters is 10 and a minimum of 25 households per community cluster, 124 households per study arm and 248 households for the study. Randomization is at the level of the clusters (selected communities). The intervention group receives counselling on LAD at a household level aimed at promoting the intake of locally available iron, folate and vitamin B12 rich foods. Also encourage the intake of food rich in enhancers of iron absorption and discouraging the intake of food rich in inhibitors of iron absorption. The primary outcome is mean haemoglobin levels in study arms. Secondary outcomes would include measurement of weight, height/length, mid upper arm circumference, dietary record, serum iron, ferritin, and other parameters of full blood count. Ethical clearance has been obtained and trial registered with Pan African Trial Registry (www.pactr.org) PACTR201906918438423.
五岁以下儿童贫血仍然是中低收入国家儿童死亡率和发病率的一个重要原因。在全球范围内，有 27%的人口贫血，其中发展中国家占 89%以上。全球贫血情况在非洲和亚洲更为严重。贫血有可能维持贫困循环，因为它阻碍儿童充分发挥其发展潜力。五岁以下儿童贫血的一个重要部分是可以预防的。当地可获得的饮食（LAD）干预措施可能是解决我们社区中高贫血患病率的可持续干预措施。本研究的目的是确定咨询对当地饮食的影响，以减少加纳北部库姆本古地区 6-59 个月儿童的贫血发生率。本研究将是一项基于社区的整群随机对照试验，有两个平行组；铁+叶酸（IFA 组），以下简称标准护理组和铁+叶酸+当地可获得饮食干预咨询（IFA+LAD 组），以下简称标准加组。研究对象为 6-56 月龄儿童。所有研究参与者都将接受铁加叶酸。每个手臂的儿童人数至少为 330 人，社区群组的数量为 10 个（每个研究手臂 5 个）。此外，由于本研究提出了两个平行组，因此五岁以下儿童的总最小研究样本量为 496，最小的社区群组总数为 10，每个社区群组至少有 25 户，每个研究手臂有 124 户，研究有 248 户。随机化是在群组（选定社区）水平上进行的。干预组在家庭层面接受关于 LAD 的咨询，旨在促进摄入当地可获得的富含铁、叶酸和维生素 B12 的食物。还鼓励摄入富含铁吸收增强剂的食物，劝阻摄入富含铁吸收抑制剂的食物。主要结果是研究组的平均血红蛋白水平。次要结果包括测量体重、身高/长度、上臂中部周长、饮食记录、血清铁、铁蛋白和全血细胞计数的其他参数。已获得伦理批准，并在泛非试验登记处（www.pactr.org）进行了试验注册 PACTR201906918438423。
