Clinical trial NCT03780348: A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
Official title: A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Acute Malnutrition
Wasting
Keywords: Weigh-for-Height/Length
Assessment
Lead sponsor: JSI Research & Training Institute, Inc.
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 510
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Reliability
timeFrame: In 3 months
measure: Efficiency of assessment
timeFrame: in 3 months
measure: Reliability of WHZ assessments done by community Health Extension Workers
timeFrame: in 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: JSI Training and Research Institute, Inc.
name: Yared A Fantaye, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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: I. Empirical data demonstrates Simpson's paradox. Nutr J. 2018 Sep 15;17(1):79. doi: 10.1186/s12937-018-0384-4.
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.
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.
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(Suppl 2):83-100. doi: 10.1111/mcn.12081.