Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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11 September 2023 |
Main ID: |
ISRCTN16311596 |
Date of registration:
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27/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluating the use of a novel, low-cost wall chart tool to rapidly identify stunted adolescents in Lilongwe, Malawi
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Scientific title:
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Evaluating the performance (in terms of accuracy and speed) of a novel wall chart, compared to traditional height-for-age measurement, for identifying stunting adolescents in Lilongwe, Malawi |
Date of first enrolment:
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15/07/2016 |
Target sample size:
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300 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN16311596 |
Study type:
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Observational |
Study design:
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Cross-sectional diagnostic accuracy study (Diagnostic)
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Phase:
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Not Applicable
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Countries of recruitment
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Malawi
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Marko
Kerac |
Address:
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London School of Hygiene & Tropical Medicine
Keppel Street
WC1E 7HT
London
United Kingdom |
Telephone:
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+44 20 7636 8636 |
Email:
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marko.kerac@lshtm.ac.uk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All children and adolescents aged 8 to under 19 years 2. Able to stand straight for measurement
Exclusion criteria: 1. Children/adolescents with disability, acute illness or other reason preventing them from standing for height measurement 2. Inability to obtain informed consent from parents or informed assent/consent from participant
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stunted growth (low height-for-age) Nutritional, Metabolic, Endocrine Stunted growth (low height-for-age)
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Intervention(s)
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Participants are purposively sampled, from poorer areas with higher prevalence of stunting and from areas where we have existing contacts with village chiefs. Each participant will have their stunting status (not stunted / stunted / severely stunted) assessed by both stunting chart and height measured using a traditional stadiometer. Each individual will be measured twice by each method, once by a health surveillance assistant (HSA - a community-level healthcare worker in Malawi) and once by a trained field worker. A different HSA will be used each day (e.g. measure the adolescents in their ‘patches’) since the aim is to test simplicity of use.
Index test: stunting chart The stunting chart is a wall chart based on the WHO Standards height-for-age z-scores. This will be developed and printed on large canvas material. Following the Nabarro Thinness chart format, bars showing age (8-19 years), will be plotted along the horizontal axis of the chart. Age bars will be plotted in half-year increments from 8 to 15.5 years, and one-year increments from 16 to 19 years. The vertical axis will show the heights plotted on a 1:1 scale and colour-coded at each z-score interval (orange for z-score -4 to -3, yellow for z-score -3 to -2 , green for z-score =-2). Children will stand against the bar corresponding to their age. Using the edge of a book or piece of paper to ensure correct alignment, the colour of the bar behind them will rapidly categorise them as “normal”, “stunted” or “severely stunted”.
Reference standard: HAZ According to the WHO, stunting is defined as a height that is more than 2 standard deviations below the WHO Child Growth Standards median, or a HAZ <-2. Each participant s HAZ will be calculated from the mean height obtained from traditional height measureme
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Primary Outcome(s)
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1. Diagnostic test performance of the index test is measured through comparison of sensitivity, specificity, positive predictive value and negative predictive value with the reference standard 2. Total time taken to use each method is measured in seconds (i.e. seconds, minutes) at the beginning and end of each test (i.e. during each test)
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Secondary Outcome(s)
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1. Local perceptions of the stunting chart is assessed using a Likert-scale in a purpose-made questionnaire at the end of the study visit 2. Performance of field tables and growth charts for classifying stunting status are determined by comparison of its diagnostic test performance against the reference standard 3. Local views on stunting is assessed using a Likert-scale and short-answer questions in a purpose-made questionnaire at the end of the study visit
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Source(s) of Monetary Support
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London School of Hygiene and Tropical Medicine, Wellcome Trust
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 1. Malawi's College of Medicine Research and Ethics Committee (COMREC), 30/06/2016, ref: P.06/16/1955
2. London School of Hygiene and Tropical Medicine Research Ethics Committee, 27/06/2016, ref: 10912
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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07/09/2016 |
URL:
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