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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
JSI Research & Training Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severe Acute Malnutrition focused on measuring Weigh-for-Height/Length, Assessment

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 17, 2018
    Last Updated
    December 17, 2018
    Sponsor
    JSI Research & Training Institute, Inc.
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    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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