A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment (Yared's-tool)

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.

Study Overview

• Status: Unknown
• Conditions: Wasting; Severe Acute Malnutrition
• Intervention / Treatment: Diagnostic test: New Method; Diagnostic test: Existing Method

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 510
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Method; 'New' weight-for-height method will be used to assess children assigned to this arm	Diagnostic test: New Method; A 'new' WHZ tool will be used to assess children.
Active Comparator: Existing Method; 'Existing' weight-for-height method will be used to assess children assigned to this arm	Diagnostic test: Existing Method; 'Existing' WHZ tools will be used to assess children
Experimental: Health Extension Workers; Health Extension workers will do weight-for-height assessment using the new method	Diagnostic test: New Method; A 'new' WHZ tool will be used to assess children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Reliability	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'	In 3 months
Efficiency of assessment	The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method	in 3 months
Reliability of WHZ assessments done by community Health Extension Workers	Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'	in 3 months

Collaborators and Investigators

• Sponsor: JSI Research & Training Institute, Inc.
• Investigators: Principal Investigator: Yared A Fantaye, MD, MPH, JSI Training and Research Institute, Inc.

Publications and helpful links

General Publications

• Laillou A, Prak S, de Groot R, Whitney S, Conkle J, Horton L, Un SO, Dijkhuizen MA, Wieringa FT. Optimal screening of children with acute malnutrition requires a change in current WHO guidelines as MUAC and WHZ identify different patient groups. PLoS One. 2014 Jul 1;9(7):e101159. doi: 10.1371/journal.pone.0101159. eCollection 2014.
• Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: I. Empirical data demonstrates Simpson's paradox. Nutr J. 2018 Sep 15;17(1):79. doi: 10.1186/s12937-018-0384-4.
• Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: III. Effect of case-load on malnutrition related mortality- policy implications. Nutr J. 2018 Sep 15;17(1):81. doi: 10.1186/s12937-018-0382-6.
• Pelletier D, Haider R, Hajeebhoy N, Mangasaryan N, Mwadime R, Sarkar S. The principles and practices of nutrition advocacy: evidence, experience and the way forward for stunting reduction. Matern Child Nutr. 2013 Sep;9 Suppl 2(Suppl 2):83-100. doi: 10.1111/mcn.12081.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Assessment; Weigh-for-Height/Length
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: JSI R&T #18-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Nutrition assessment data is sensitive for the country and it can only be shared if the regional health bureau allows. It needs time to get their decision

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No