Yared's-tool: A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment

Sponsor
JSI Research & Training Institute, Inc. (Other)
Overall Status
Unknown status
CT.gov ID
NCT03780348
Collaborator
(none)
510
3
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: New Method
  • Diagnostic Test: Existing Method
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
510 participants
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 methodChildren will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method
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.
Primary Purpose:
Diagnostic
Official Title:
A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Feb 28, 2019
Anticipated Study Completion Date :
Feb 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: New Method

'New' weight-for-height method will be used to assess children assigned to this arm

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

Active Comparator: Existing Method

'Existing' weight-for-height method will be used to assess children assigned to this arm

Diagnostic Test: Existing Method
'Existing' WHZ tools will be used to assess children

Experimental: Health Extension Workers

Health Extension workers will do weight-for-height assessment using the new method

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

Outcome Measures

Primary Outcome Measures

  1. Diagnostic Reliability [In 3 months]

    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'

  2. Efficiency of assessment [in 3 months]

    The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method

  3. Reliability of WHZ assessments done by community Health Extension Workers [in 3 months]

    Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • JSI Research & Training Institute, Inc.

Investigators

  • Principal Investigator: Yared A Fantaye, MD, MPH, JSI Training and Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JSI Research & Training Institute, Inc.
ClinicalTrials.gov Identifier:
NCT03780348
Other Study ID Numbers:
  • JSI R&T #18-46
First Posted:
Dec 19, 2018
Last Update Posted:
Dec 19, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by JSI Research & Training Institute, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2018