Mihrshahi Seema, Ara Gulshan, Khanam Mansura, Rasheed Sabrina, Agho Kingsley Emwinyore, Kabir Akm Iqbal, Roy S K, Haider Rukhsana, Derakhshani Hamadani Jena, Tofail Fahmida, Alam Ashraful, Dibley Michael J
Department of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, Macquarie Park, Australia.
Sydney School of Public Health, The University of Sydney, Sydney, Australia.
JMIR Res Protoc. 2022 Feb 7;11(2):e31475. doi: 10.2196/31475.
The aim of this study is to assess if peer counseling of women improves breastfeeding, complementary feeding practices, and child growth, and thus reduces the prevalence of undernutrition in children up to 4 years of age.
Lack of exclusive breastfeeding and inappropriate complementary feeding are critical factors in reducing child undernutrition, morbidity, and mortality. There are reported trials of peer counseling to improve breastfeeding; however, they did not examine the efficacy of peer counseling to improve complementary feeding or the long-term impacts on child growth and development.
This study has used a community-based, cluster-randomized controlled trial with a superiority design and 2 parallel treatment arms. It is assessing the impact of peer counseling, starting in late pregnancy up to 1 year after delivery, on child feeding practices, growth, and development with follow-up until 48 months of age. The study site was Mirpur, a densely populated area in Dhaka. Using satellite maps and geographic information system mapping, we constructed 36 clusters with an average population of 5000 people. We recruited pregnant women in the third trimester aged 16-40 years, with no more than 3 living children. Trained peer counselors visited women at home twice before delivery, 4 times in the first month, monthly from 2 to 6 months, and again at 9 and 12 months. Trained research assistants collected anthropometric measurements. The primary outcome will be differences in child stunting and mean length for age at 6, 12, 15, and 18 months. Secondary outcomes will be differences in the percentage of women exclusively breastfeeding in the mean duration of any breastfeeding and in the percentage of children at 6 and 9 months of age who receive solid, semisolid, or soft foods; and the percentage of children consuming foods from 4 or more food groups at 9, 12, 15, and 18 months. We will assess the mean cognitive function scores from the Ages and Stages Questionnaire (9 and 18 months) and Bayley tests (24 and 36 months).
We identified 65,535 people in mapped residences, from which we defined 36 clusters and randomly allocated them equally to intervention or control groups stratified by cluster socioeconomic status. From July 2011 to May 2013, we identified 1056 pregnant women and 993 births in the intervention group and 994 pregnancies and 890 births in the control group. At 18 months, 692 children remained in the intervention group and 551 in the control group. From January 2015 to February 2017, we conducted the long-term follow-up of the cohort. We have now completed the data collection and processing and have started analyses.
This study will help fill the evidence gap about the short- and long-term impact of peer counseling on improving infant feeding, preventing childhood undernutrition, and enhancing child cognitive development.
ClinicalTrials.gov NCT01333995; https://clinicaltrials.gov/ct2/show/NCT01333995.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31475.
本研究旨在评估同伴咨询对改善母乳喂养、辅食添加习惯及儿童生长发育的效果，进而降低4岁以下儿童营养不良的发生率。
纯母乳喂养的缺乏和不恰当的辅食添加是导致儿童营养不良、发病率和死亡率上升的关键因素。已有关于同伴咨询改善母乳喂养的试验报道；然而，这些试验未考察同伴咨询对改善辅食添加的效果，以及对儿童生长发育的长期影响。
本研究采用基于社区的整群随机对照试验，采用优效性设计，设有2个平行治疗组。该研究评估从妊娠晚期至产后1年的同伴咨询对儿童喂养习惯、生长发育的影响，并随访至48月龄。研究地点为达卡人口密集的米尔布尔地区。利用卫星地图和地理信息系统绘图，我们构建了36个群组，平均人口为5000人。我们招募了孕晚期年龄在16 - 40岁、存活子女不超过3个的孕妇。经过培训的同伴咨询师在分娩前到家探访孕妇2次，产后第1个月探访4次，2至6个月每月探访1次，9个月和12个月时再次探访。经过培训的研究助理收集人体测量数据。主要结局指标为6、12、15和18月龄时儿童发育迟缓情况及年龄别身长均值的差异。次要结局指标为纯母乳喂养女性的比例、任何母乳喂养的平均持续时间、6和9月龄接受固体、半固体或软质食物的儿童比例；以及9、12、15和18月龄摄入4种或更多食物组食物的儿童比例。我们将通过年龄与发育进程问卷（9和18月龄）和贝利测试（24和36月龄）评估平均认知功能得分。
我们在地图标注的住所中识别出65535人，从中定义了36个群组，并根据群组社会经济状况将它们随机等分为干预组或对照组。2011年7月至2013年5月，我们在干预组识别出1056名孕妇和993例分娩，在对照组识别出994例妊娠和890例分娩。18月龄时，干预组有692名儿童，对照组有551名儿童。2015年1月至2017年2月，我们对该队列进行了长期随访。我们现已完成数据收集和处理，并开始进行分析。
本研究将有助于填补关于同伴咨询对改善婴儿喂养、预防儿童营养不良及促进儿童认知发育的短期和长期影响方面的证据空白。
ClinicalTrials.gov NCT01333995；https://clinicaltrials.gov/ct2/show/NCT01333995。
国际注册报告识别码（IRRID）：DERR1-10.2196/31475。
