A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment (Yared's-tool)
Primary Purpose
Severe Acute Malnutrition, Wasting
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New Method
Existing Method
Sponsored by
About this trial
This is an interventional diagnostic trial for Severe Acute Malnutrition focused on measuring Weigh-for-Height/Length, Assessment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
New Method
Existing Method
Health Extension Workers
Arm Description
'New' weight-for-height method will be used to assess children assigned to this arm
'Existing' weight-for-height method will be used to assess children assigned to this arm
Health Extension workers will do weight-for-height assessment using the new method
Outcomes
Primary Outcome Measures
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'
Efficiency of assessment
The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method
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'
Secondary Outcome Measures
Full Information
NCT ID
NCT03780348
First Posted
December 17, 2018
Last Updated
December 17, 2018
Sponsor
JSI Research & Training Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03780348
Brief Title
A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
Acronym
Yared's-tool
Official Title
A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JSI Research & Training Institute, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition, Wasting
Keywords
Weigh-for-Height/Length, Assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New Method
Arm Type
Experimental
Arm Description
'New' weight-for-height method will be used to assess children assigned to this arm
Arm Title
Existing Method
Arm Type
Active Comparator
Arm Description
'Existing' weight-for-height method will be used to assess children assigned to this arm
Arm Title
Health Extension Workers
Arm Type
Experimental
Arm Description
Health Extension workers will do weight-for-height assessment using the new method
Intervention Type
Diagnostic Test
Intervention Name(s)
New Method
Intervention Description
A 'new' WHZ tool will be used to assess children.
Intervention Type
Diagnostic Test
Intervention Name(s)
Existing Method
Intervention Description
'Existing' WHZ tools will be used to assess children
Primary Outcome Measure Information:
Title
Diagnostic Reliability
Description
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'
Time Frame
In 3 months
Title
Efficiency of assessment
Description
The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method
Time Frame
in 3 months
Title
Reliability of WHZ assessments done by community Health Extension Workers
Description
Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'
Time Frame
in 3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yared A Fantaye, MD, MPH
Phone
+251 911944651
Email
yared_abebe@et.jsi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yared A Fantaye, MD, MPH
Organizational Affiliation
JSI Training and Research Institute, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
30217205
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.
Results Reference
background
PubMed Identifier
30217201
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.
Results Reference
background
PubMed Identifier
24983995
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.
Results Reference
background
PubMed Identifier
24074320
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.
Results Reference
background
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A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
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