Khan Gul Nawaz, Kureishy Sumra, Ariff Shabina, Habib Muhammad Atif, Usmani Asra Abeer, Mubarik Areeba, Hussain Masawar, Akbar Naveed, Rodriguez de Castro Pablo, Garzon Alba Cecilia, de Pee Saskia, Soofi Sajid Bashir
Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.
World Food Programme, Islamabad, Pakistan.
JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.
In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country-43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households.
The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months.
A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package.
The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020.
The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months.
ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19001.
在巴基斯坦，过去二十年来，5岁以下儿童发育迟缓的患病率一直高于全球临界水平，2018年发育迟缓率为40.2%。在全国范围内，农村地区以及最贫困家庭的儿童受发育迟缓影响最为严重，农村地区为43.2%，最贫困五分之一人口家庭为51.4%。作为一个持续存在的公共卫生问题，预防发育迟缓必须成为国家优先事项，以确保人力资本发展，尤其是在最贫困家庭中。
本研究的主要目的是确定中等剂量的脂质营养补充剂（LNS）与无条件现金转移以及社会行为改变沟通（SBCC）相结合对6至23个月儿童发育迟缓减少的影响。
将在巴基斯坦旁遮普省的拉希姆亚尔汗地区进行一项五臂整群随机对照试验。干预方案将包括：（1）仅现金；（2）现金加LNS；（3）现金加SBCC；（4）现金加SBCC和LNS。对照组将接受常规标准护理。我们将招募6个月大的儿童，每月随访直至24个月大。总共将招募2000名儿童，每组400名，以检测24个月大儿童发育迟缓患病率降低20%的情况。将在入组时以及18个月期间每月收集身高、体重、食物摄入量、对干预措施的依从性、发病率及其他相关数据。过程评估将通过焦点小组讨论以及与目标人群和相关利益攸关方的深入访谈来评估干预措施的可接受性以及实施的潜在障碍。此外，将进行成本分析以评估每个干预方案的成本效益。
该研究方案于2017年1月4日获得巴基斯坦阿迦汗大学伦理审查委员会的批准。数据收集于2017年5月开始，并于2019年7月完成。数据分析尚未完成。本研究将探讨由贝娜齐尔收入支持计划提供的现金转移（有或没有额外的LNS和SBCC）组成的干预方案在预防儿童发育迟缓方面的有效性。我们预计结果将于2020年秋季在同行评审期刊上发表。
该试验的结果将为哪些干预方案可对儿童线性生长产生显著影响提供有力证据，并设计有效的干预方案以预防6至23个月儿童的发育迟缓。
ClinicalTrials.gov NCT03299218；https://clinicaltrials.gov/ct2/show/NCT03299218。
国际注册报告识别码（IRRID）：DERR1-10.2196/19001。
