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临床试验/NCT03780348
NCT03780348Unknown不适用

A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment

JSI Research & Training Institute, Inc.0 个研究点目标入组 510 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
510
主要终点
Reliability of WHZ assessments done by community Health Extension Workers

研究概览

简要总结

Weight-for-height/length z-score is one of the indicators used to diagnose acute malnutrition. In the existing method, the assessment involves three steps and takes significant time with a wider room for errors. A new tool is developed to address these drawbacks. A preliminary testing done show encouraging results, but a more robust study is needed. This research will b done with the objective of comparing diagnostic efficiency and reliability of the 'new' method against the 'existing' one using a diagnostic randomized clinical trial method.

详细描述

Acute malnutrition is a major underlying and direct cause of child death. Weight-for-height/length z score (WHZ) is one of the indicators used to assess nutritional status of children. In the existing method, the assessment involves three steps; measuring height, measuring weight and deciding WHZ using a reference graphs or tables. The assessment takes significant time and has wider room for errors. Due to these drawbacks, it is not used at community level where regular active finding takes place.

A new tool is developed to address these drawbacks. It reduces the steps to two aiming at reducing errors and saving time and energy. This study will compare efficiency and reliability of WHZ assessments done with the new tool against the existing method using a diagnostic randomized clinical trial.

Trained health workers will do WHZ assessments in under five children mobilized for nutrition screening program. The 'average time' needed and proportions of 'classification errors' will be compared between the new and the existing methods. Assessments done by two anthropometry experts will be used as gold standard.

The study will determine the gains of the new tool and can potentially change the global practice and help early detection of huge number of wasted children that are being missed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The caregivers of the children, the care provider linking the children to either of the groups and the investigator will not know which group each child is joining and which group is using which method.

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children under five years of age living in the study area.

排除标准

  • Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.

研究组 & 干预措施

Existing Method

Active Comparator

'Existing' weight-for-height method will be used to assess children assigned to this arm

干预措施: Existing Method (Diagnostic Test)

New Method

Experimental

'New' weight-for-height method will be used to assess children assigned to this arm

干预措施: New Method (Diagnostic Test)

Health Extension Workers

Experimental

Health Extension workers will do weight-for-height assessment using the new method

干预措施: New Method (Diagnostic Test)

结局指标

主要结局

Reliability of WHZ assessments done by community Health Extension Workers

时间窗: in 3 months

Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'

Efficiency of assessment

时间窗: in 3 months

The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method

Diagnostic Reliability

时间窗: In 3 months

Proportion of 'assessment errors' between the groups will be compared against that of the gold standard (i.e the assessment done by two experts for each child'

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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