An observational study in Child Malnutrition, Wasting Syndrome and Stunting, sponsored by World Vision US. Completed at 1 site in Vietnam. Open to participants aged 1 Month to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by World Vision US · Observational
This study will evaluate whether a portable laser device can accurately measure the height and length of children younger than 5 years in Quang Nam, Vietnam. Accurate height and length measurements are important for monitoring child growth and identifying children who may have wasting or stunting and need referral for health or nutrition services. Standard wooden measuring boards are reliable but can be heavy, costly, and difficult to use in community outreach settings.
The study will compare the laser device with the ShorrBoard, a standard wooden height/length board. Children aged 0-59 months whose caregivers provide consent will have their length (for younger children) or standing height (for older children) measured using both devices by trained community health workers and expert anthropometrists.
The main question is: Does the laser device produce height and length measurements that agree closely with the standard ShorrBoard and are similarly precise and reliable when used by frontline health workers?
The study hypothesis is that the laser device will show high agreement with the ShorrBoard and will be at least as precise and reliable for measuring children's height and length in a rural outreach setting. The study will also examine whether use of the two devices leads to different classifications of child wasting or stunting based on standard growth indicators.
This is a prospective, cross-sectional validation study conducted in Quang Nam Province, Vietnam, to evaluate a portable laser-based anthropometric device for measuring recumbent length in children aged 0-23.9 months and standing height in children aged 24-59.9 months. The study is embedded within the sampling frame of the national routine child-growth monitoring activities. Quang Nam was selected because it includes hot and humid field conditions, where a portable device intended for community outreach must perform reliably.
The investigational device is a compact, battery-powered laser device designed for field measurement of child length and height. It will be evaluated against the ShorrBoard, a wooden length/height board used as the reference measurement method. The laser device is designed to be lighter, more portable, and easier to transport than conventional boards while retaining the measurement performance needed for child growth assessment in outreach settings. Measurements will be performed by trained community health workers and expert anthropometrists to assess device performance under conditions relevant to routine service delivery.
All households with children younger than 60 months in selected villages will be invited to participate. Data collection will occur across eight villages. Teams will include two measurers and one recorder; expert teams will remain consistent across villages, while volunteer community-health-worker teams will be recruited and trained for groups of villages.
Each enrolled child will undergo repeated length or height measurements with both the laser device and ShorrBoard. Children younger than 24 months will be measured lying down for recumbent length; children aged 24-59.9 months will be measured standing. Each device will be calibrated using a meter rule before use. Measurements will be recorded to the nearest 0.1 cm. When two repeated measurements differ by more than 0.7 cm, a third measurement will be obtained; the two closest values will be retained for analysis.
To reduce potential measurement-order bias, the device used first by community health worker teams will alternate by day. Individual staff roles will remain stable during each data-collection day. Measurement locations will be designated by device, and teams will rotate between locations to balance environmental conditions such as lighting and temperature. Measurements by the different teams will be separated by at least 30 minutes to reduce recall effects while allowing assessment of consistency across time.
The sample size will be calculated to provide 90% statistical power to establish equivalence between the laser device and the conventional ShorrBoard using the Two One-sided Tests (TOST) procedure, with a prespecified equivalence margin of ±0.2 cm and a 5% significance level (α = 0.05). Assuming a true mean difference of 0 cm and a standard deviation of paired measurement differences of 0.671 cm, approximately 124 children with complete paired measurements will be required per age group. After adjusting for an anticipated 20% dropout or incomplete measurement rate, the minimum recruitment target will be 155 children per age group, or 310 children in total. Because the study will be conducted alongside routine growth-monitoring activities, all eligible children who present within the selected catchment areas may be measured, even if the target sample is exceeded.
Agreement between the laser device and reference measurements will be assessed using Bland-Altman methods, including the mean between-method difference and limits of agreement. Inter-method technical error of measurement will also be calculated. Reliability and repeatability will be assessed with intraclass correlation coefficients, including consistency across measurers, devices, and measurement time points. Precision of repeated measurements will be assessed using standard deviations, coefficients of variation, and intra-rater technical error of measurement. Analyses will additionally examine whether the choice of measurement device changes categorical classification based on weight-for-length/height and length/height-for-age indices; paired categorical classifications will be compared using McNemar's test.
Data will be collected electronically using KoboCollect on Android devices, with paper tools available as backup. Electronic forms will incorporate required fields, range checks, and skip logic to reduce entry errors. Equipment calibration results will be recorded before measurement sessions. Field data will be reviewed daily using Excel and ENA for SMART/ENA 2008 software to identify digit preference, implausible anthropometric values, or enumerator-specific quality concerns. Measurements requiring verification may be repeated the following day, and field staff may be retrained when data-quality checks indicate a need.
Data will be transferred from encrypted, password-protected devices to the World Vision KoboCollect server when connectivity is available and subsequently to secure London School of Hygiene \& Tropical Medicine servers for processing. Identifiable information will be stored separately from study measurements and linked only through a study identifier. The analytical dataset will be de-identified before analysis. Data cleaning, processing, and analysis will be conducted in R using reproducible analysis scripts. Missing, unavailable, or implausible measurements will be reviewed against source records and protocol-based quality rules; measurements that cannot be verified will be documented and handled as missing in the relevant analysis.
This is a minimal-risk, non-invasive measurement study. Trained staff will follow standardized procedures intended to maintain children's comfort and safe positioning during measurement. Children identified through study measurements as meeting criteria for severe wasting will be referred to the nearest health facility for assessment and services according to applicable national guidance.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's enrollment of 571 is above the median of 300 across 32 observational studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →World Vision US is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is drawn from community-dwelling children in selected villages in Quang Nam Province, Vietnam. Recruitment is embedded within the local routine child-growth monitoring and surveillance activities coordinated with the Ministry of Health and the provincial Centre for Disease Control. Households with young children in the selected villages will be mobilized and invited to attend measurement activities. Data collection will take place across eight villages, using trained community health worker teams and expert anthropometrists. The setting represents rural outreach conditions, including hot and humid environmental conditions, in which portable child anthropometry devices may be used.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laser Height/Length Measuring Device is the innovative digital device being validated
Conventional wooden height board
Accuracy and equivalence of laser height/length measurements compared with the ShorrBoard
The mean paired difference in height/length measurements (cm) between the laser device and conventional ShorrBoard when operated by expert measurers. Equivalence will be assessed using the Two One-Sided Tests (TOST) procedure with a prespecified equivalence margin of ±0.2 cm and a significance level of 0.05. Equivalence will be established if the entire 90% confidence interval of the mean paired difference falls within -0.2 to +0.2 cm.
Time frame: Day 1
Intra-observer measurement precision (Technical Error of Measurement, TEM)
Measurement precision will be evaluated using TEM, calculated from repeated height/length measurements obtained with each device by expert measurers and community volunteers. Two measurements will be obtained initially. If the difference exceeds 0.7 cm, a third measurement will be taken, and the two closest readings will be retained. TEM will be calculated as √\[Σ(d²)/(2n)\] and reported in centimetres and millimetres. The expert ShorrBoard TEM must be less than 0.4 cm to qualify as an acceptable reference measurement process.
Time frame: Day 1
Agreement between laser device and ShorrBoard height/length measurements
Agreement between the two devices will be evaluated using Bland-Altman analysis, including mean measurement bias and 95% limits of agreement (mean paired difference ±1.96 standard deviations). Results will be expressed in centimetres and presented overall and separately by measurer cadre.
Time frame: Day 1
Reliability and concordance of height/length measurements
Agreement between measurements obtained using the laser device and ShorrBoard will be evaluated using the intraclass correlation coefficient for absolute agreement (ICC\[A,1\]) and Lin's concordance correlation coefficient (CCC). These statistics will quantify the consistency and concordance of measurements between devices.
Time frame: Day 1
Measurement accuracy by measurer cadre
The mean paired difference between laser and ShorrBoard measurements will be calculated separately for expert measurers and community volunteers to determine whether device accuracy differs according to measurer experience.
Time frame: Day 1
Differences between expert and community volunteer measurements
The mean differences in height/length measurements between expert measurers and community volunteers will be evaluated separately for the laser device and ShorrBoard to assess measurer-related systematic bias.
Time frame: Day 1
Device-by-measurer interaction
A linear mixed-effects model will assess whether the difference between laser and ShorrBoard measurements varies by measurer cadre. The interaction will be quantified as the difference between the volunteer and expert laser-minus-ShorrBoard contrasts.
Time frame: Day 1
Differences in anthropometric z-scores
Differences in height-for-age/length-for-age (HAZ/LAZ) and weight-for-height/weight-for-length (WHZ/WLZ) z-scores derived from laser and ShorrBoard measurements will be calculated using WHO 2006 Child Growth Standards.
Time frame: During a single study visit; repeated measurements with both devices are obtained at least 30 minutes apart
Agreement in stunting classification
Agreement in classifying children as stunted (HAZ/LAZ \<-2) or severely stunted (HAZ/LAZ \<-3) will be compared between devices using cross-tabulations, Cohen's kappa, and McNemar's test.
Time frame: Day 1
Agreement in wasting classification
Agreement in classifying children as wasted (WHZ/WLZ \<-2) or severely wasted (WHZ/WLZ \<-3) will be compared between devices using cross-tabulations, Cohen's kappa, and McNemar's test.
Time frame: Day 1
Differences in estimated prevalence of stunting and wasting
The prevalence of stunting, severe stunting, wasting, and severe wasting will be estimated separately using laser-derived and ShorrBoard-derived measurements. Paired prevalence differences will be reported in percentage points with 95% confidence intervals.
Time frame: Day 1
Measurement accuracy and precision by age group
Measurement bias, TEM, and limits of agreement will be compared between children aged 1-23 months (recumbent length) and children aged 24-59 months (standing height).
Time frame: Day 1 to Day 7
Measurement accuracy across child stature
Measurement bias and agreement will be examined across quartiles of expert ShorrBoard-measured stature. Regression analysis will assess whether the magnitude of measurement differences changes systematically with child height/length.
Time frame: Day 1 to Day 7
Variability in measurement differences
Differences in measurement variability between devices, measurer cadres, and measurement positions will be evaluated using variance comparisons, the Brown-Forsythe test, and regression-based assessment of heteroscedasticity.
Time frame: Day 1 to Day 7
Frequency of requiring a third measurement
The proportion of measurement occasions requiring a third reading because the first two measurements differ by more than 0.7 cm will be calculated separately for the laser device and ShorrBoard and by measurer cadre. This will assess repeat-measurement burden and operational feasibility.
Time frame: Day 1
Measurement errors and protocol adherence
The frequency and proportion of unresolved measurement discrepancies, missing required third readings, unusually large measurement errors, and deviations from the prescribed measurement protocol will be described for each device and measurer cadre.
Time frame: Day 1 to Day 7
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in the publication will be shared. This will include relevant participant-level demographic and baseline characteristics, anthropometric measurements, intervention allocation, follow-up measurements, and primary and secondary outcome variables used in the final analyses. Derived variables required to reproduce the published analyses will also be included. All direct identifiers and any variables that could reasonably enable participant re-identification will be removed prior to sharing. The shared dataset will therefore contain only the minimum de-identified participant-level data necessary to reproduce and further examine the reported study findings.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: The study protocol, statistical analysis plan, consent forms, and quantitative and qualitative tools/questionnaires and data will be available from Oct 15, 2026 and accessible for 10 years after publication (December 2036).
Access criteria: Access to the anonymized individual participant data (IPD) and supporting documentation will be provided to qualified researchers, policymakers, and other stakeholders with a legitimate scientific or public health interest. Users will be able to access the de-identified dataset, data dictionary, study protocol, statistical analysis plan, study tools, and, where applicable, analytical code. The data will be hosted in the Open Science Framework repository, where it will be assigned a DOI. Access will be granted under a controlled access model: interested users will be required to submit a request outlining the intended use of the data and agree to the repository's data use conditions. Upon approval, access will be provided through the repository in a secure and responsible manner, in line with ethical approvals and participant consent.
Data sharing details ↗ · osf.io
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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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