<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03780348</url>
  </required_header>
  <id_info>
    <org_study_id>JSI R&amp;T #18-46</org_study_id>
    <nct_id>NCT03780348</nct_id>
  </id_info>
  <brief_title>A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment</brief_title>
  <acronym>Yared's-tool</acronym>
  <official_title>A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JSI Research &amp; Training Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JSI Research &amp; Training Institute, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight-for-height/length z-score is one of the indicators used to diagnose acute&#xD;
      malnutrition. In the existing method, the assessment involves three steps and takes&#xD;
      significant time with a wider room for errors. A new tool is developed to address these&#xD;
      drawbacks. A preliminary testing done show encouraging results, but a more robust study is&#xD;
      needed. This research will b done with the objective of comparing diagnostic efficiency and&#xD;
      reliability of the 'new' method against the 'existing' one using a diagnostic randomized&#xD;
      clinical trial method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute malnutrition is a major underlying and direct cause of child death.&#xD;
      Weight-for-height/length z score (WHZ) is one of the indicators used to assess nutritional&#xD;
      status of children. In the existing method, the assessment involves three steps; measuring&#xD;
      height, measuring weight and deciding WHZ using a reference graphs or tables. The assessment&#xD;
      takes significant time and has wider room for errors. Due to these drawbacks, it is not used&#xD;
      at community level where regular active finding takes place.&#xD;
&#xD;
      A new tool is developed to address these drawbacks. It reduces the steps to two aiming at&#xD;
      reducing errors and saving time and energy. This study will compare efficiency and&#xD;
      reliability of WHZ assessments done with the new tool against the existing method using a&#xD;
      diagnostic randomized clinical trial.&#xD;
&#xD;
      Trained health workers will do WHZ assessments in under five children mobilized for nutrition&#xD;
      screening program. The 'average time' needed and proportions of 'classification errors' will&#xD;
      be compared between the new and the existing methods. Assessments done by two anthropometry&#xD;
      experts will be used as gold standard.&#xD;
&#xD;
      The study will determine the gains of the new tool and can potentially change the global&#xD;
      practice and help early detection of huge number of wasted children that are being missed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Reliability</measure>
    <time_frame>In 3 months</time_frame>
    <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'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficiency of assessment</measure>
    <time_frame>in 3 months</time_frame>
    <description>The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of WHZ assessments done by community Health Extension Workers</measure>
    <time_frame>in 3 months</time_frame>
    <description>Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">510</enrollment>
  <condition>Severe Acute Malnutrition</condition>
  <condition>Wasting</condition>
  <arm_group>
    <arm_group_label>New Method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'New' weight-for-height method will be used to assess children assigned to this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing Method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'Existing' weight-for-height method will be used to assess children assigned to this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Extension Workers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health Extension workers will do weight-for-height assessment using the new method</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>New Method</intervention_name>
    <description>A 'new' WHZ tool will be used to assess children.</description>
    <arm_group_label>Health Extension Workers</arm_group_label>
    <arm_group_label>New Method</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Existing Method</intervention_name>
    <description>'Existing' WHZ tools will be used to assess children</description>
    <arm_group_label>Existing Method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children under five years of age living in the study area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children for whom weigh-for-height assessments can not be done due to physical&#xD;
             deformities and disabilities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yared A Fantaye, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>JSI Training and Research Institute, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yared A Fantaye, MD, MPH</last_name>
    <phone>+251 911944651</phone>
    <email>yared_abebe@et.jsi.org</email>
  </overall_contact>
  <reference>
    <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>
    <PMID>30217205</PMID>
  </reference>
  <reference>
    <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>
    <PMID>30217201</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24983995</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24074320</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weigh-for-Height/Length</keyword>
  <keyword>Assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Severe Acute Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03780348
org study id: JSI R&T #18-46
nct id: NCT03780348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Triple (Participant, Care Provider, Investigator)
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.
measure: Diagnostic Reliability
time frame: In 3 months
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'
measure: Efficiency of assessment
time frame: in 3 months
description: The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method
measure: Reliability of WHZ assessments done by community Health Extension Workers
time frame: in 3 months
description: Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'
arm group label: New Method
arm group type: Experimental
description: 'New' weight-for-height method will be used to assess children assigned to this arm
arm group label: Existing Method
arm group type: Active Comparator
description: 'Existing' weight-for-height method will be used to assess children assigned to this arm
arm group label: Health Extension Workers
arm group type: Experimental
description: Health Extension workers will do weight-for-height assessment using the new method
intervention type: Diagnostic Test
intervention name: New Method
description: A 'new' WHZ tool will be used to assess children.
arm group label: Health Extension Workers
arm group label: New Method
intervention type: Diagnostic Test
intervention name: Existing Method
description: 'Existing' WHZ tools will be used to assess children
arm group label: Existing Method
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
last name: Yared A Fantaye, MD, MPH
role: Principal Investigator
affiliation: JSI Training and Research Institute, Inc.
last name: Yared A Fantaye, MD, MPH
phone: +251 911944651
email: yared_abebe@et.jsi.org
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.
PMID: 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: 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.
PMID: 30217201
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.
PMID: 24983995
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.
PMID: 24074320
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Severe Acute Malnutrition
sharing ipd: No
ipd 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