Evaluating the use of a novel, low-cost wall chart tool to rapidly identify stunted adolescents in Lilongwe, Malawi

Plain English Summary

Background and study aims
Stunting is a form of malnutrition where children are too short for their age. It currently affects around 40% of children in Malawi. The current gold standard (best available method) for identifying stunted children involves assessing their height-for-age and comparing that against the reference population (WHO growth standards). This requires accurate height measurement, age assessment, calculation and comparison against reference population (z-score). All these take time and can be difficult in environments such as Malawi where staff numbers, measuring equipment and other resources are limited. As a result, assessing stunting is often of low priority or missed all together, and this vulnerable group of children and adolescents are not identified. Effective identification of stunting in older children and adolescents is the first step towards addressing this public health problem. This project aims to use a new, low-cost tool for the identification of stunted children. The tool is a simple wall chart that can be used without a lot of training to quickly identify stunted children and adolescents. The aim of this study is to find out whether the stunting chart is able to identify stunting as accurately as the gold standard, and if it is quicker to perform.

Who can participate?
All children and adolescents aged 8 to under 19, who are able to stand up straight for measurement.

What does the study involve?
All participants attend a single study visit at which their stunting status assessed using both the new wall chart and gold standard measurement by health surveillance assistant (HAS, community health workers). The stunting chart is printed on a large canvas and has age bars marked on it showing the correct height-for-age ranges, with colours marking ranges of “normal”, “stunted” or “severely stunted”. Children stand against the bar corresponding to their age and using a book or piece of paper, the HAS is able to see their stunting status by the colour. The gold standard measurement involves having height and weight measured and used to calculate their z-score to find out their stunting status. The measurements are alternated between visits for fairness, and each procedure is timed. At the end of the study, the results of the two tests are compared to see how accurate the stunting chart is in comparison to the gold standard. In addition, the time taken to perform the tests are reviewed to see whether the stunting chart is more efficient.

What are the possible benefits and risks of participating?
Participants may benefit from increased awareness about the problem of stunting in Malawi. There are no notable risks involved with participating.

Where is the study run from?
Malawi Epidemiology and Intervention Research Unit (Malawi)

When is the study starting and how long is it expected to run for?
January 2016 to September 2016

Who is funding the study?
1. London School of Hygiene and Tropical Medicine (UK)
2. Wellcome Trust (UK)

Who is the main contact?
Dr Marko Kerac
marko.kerac@lshtm.ac.uk

Study website

Type

Scientific

Contact name

Dr Marko Kerac

ORCID ID

http://orcid.org/0000-0002-3745-7317

Contact details

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 20 7636 8636
marko.kerac@lshtm.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N/A

Scientific title

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

Acronym

Study hypothesis

1. Compared to gold standard stadiometer-measured height-for-age-based assessment, the "stunting chart" will have adequate performance for use in the community for identifying stunting
2. The stunting chart will be time-saving compared to traditional HAZ measurement

Ethics approval(s)

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

Study design

Cross-sectional diagnostic accuracy study

Primary study design

Observational

Secondary study design

Cross sectional study

Study setting(s)

Community

Study type

Diagnostic

Patient information sheet

See additional files

Condition

Stunted growth (low height-for-age)

Intervention

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 measurement. This involves height measurement using a standard Leicester stadiometer. Two readings will be obtained to check for agreement as per WHO guidelines. If the two readings are outside a tolerance limit of 0.7cm, both investigators will re-measure until they agree. Stunting status according to HAZ will be used as the reference status to compare the accuracy of stunting chart and traditional height measurement.
Additionally, the HSAs will use the WHO simplified field tables and WHO growth charts to identify whether the participant is "normal", "stunted" or "severely stunted".

There is no follow up for participants. The two tests are conducted consecutively for each participant and the same HSA completes both measurements. The order of the tests is alternated so that there is no bias towards one or the other test.

Intervention type

Device

Pharmaceutical study type(s)

Not Applicable

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

MEIRU wall chart

Primary outcome measure

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)

Secondary outcome measures

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

Overall study start date

29/01/2016

Overall study end date

07/09/2016

Reason abandoned (if study stopped)

Participant inclusion criteria

1. All children and adolescents aged 8 to under 19 years
2. Able to stand straight for measurement

Participant type(s)

Healthy volunteer

Age group

Child

Lower age limit

8 Years

Upper age limit

18 Years

Sex

Both

Target number of participants

300

Total final enrolment

244

Participant 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

Recruitment start date

15/07/2016

Recruitment end date

07/08/2016

Countries of recruitment

Malawi, United Kingdom

Study participating centre

Malawi Epidemiology and Intervention Research Unit
Community Health Sciences Unit (CHSU) Malawi
Mthunthama Road
Area 3
Lilongwe
-
United Kingdom

Organisation

London School of Hygiene and Tropical Medicine

Sponsor details

Keppel Street
London
WC1E 7HT
England
United Kingdom
+44 20 7636 8636
postmaster@lshtm.ac.uk

Sponsor type

University/education

Website

ROR

https://ror.org/00a0jsq62

Funder type

University/education

Funder name

London School of Hygiene and Tropical Medicine

Alternative name(s)

London School of Hygiene & Tropical Medicine, LSHTM

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

United Kingdom

Publication and dissemination plan

1. Initial results will be disseminated through a London School of Hygiene and Tropical Medicine (LSHTM) MSc project
2. Findings will be shared with the participating communities via HSAs and field workers who took part
3. Results will be submitted for wider distribution and publication both in Malawi and internationally

2017 results presented at the Action Against Hunger 'Research for Nutrition' Conference in https://www.ennonline.net/attachments/2694/ACF_MEIRU-chart_v.1.3_possible.pdf

Intention to publish date

07/09/2017

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Available on request

Study outputs

• ISRCTN16311596_PIS_26Jul16_ChildrenandAdolescents_Chichewa_V5.docx Uploaded 28/07/2016
• ISRCTN16311596_PIS_26Jul16_ChildrenandAdolescents_English_V5.docx Uploaded 28/07/2016
• ISRCTN16311596_PIS_26Jul16_HealthWorkers_Chichewa_V5.docx Uploaded 28/07/2016
• ISRCTN16311596_PIS_26Jul16_HealthWorkers_English_V5.docx Uploaded 28/07/2016
• ISRCTN16311596_PIS_26Jul16_Parents_English_V5.docx Uploaded 28/07/2016
• ISRCTN16311596_PIS_26Jul16_Parents_Chichewa_V5.docx Uploaded 28/07/2016