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

Severe Acute Malnutrition Clinical Trial

— Yared's-tool  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03780348
• Other study ID #: JSI R&T #18-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2018
• Source: JSI Research & Training Institute, Inc.
• Contact: Yared A Fantaye, MD, MPH
• Phone: +251 911944651
• Email: yared_abebe[@]et.jsi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 510
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition
• Wasting

Intervention

Diagnostic Test:
• New Method
A 'new' WHZ tool will be used to assess children.
• Existing Method
'Existing' WHZ tools will be used to assess children

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JSI Research & Training Institute, Inc.

References & Publications (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: I. Empirical data demonstrates Simpson's paradox. Nutr J. 2018 Sep 15;17(1):79. doi: 10.1186/s12937-018-0384-4. — View Citation

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. — View Citation

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. — View Citation

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 2:83-100. doi: 10.1111/mcn.12081. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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