Trial · NCT07906067
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Accuracy and equivalence of laser height/length measurements compared with the ShorrBoard | Day 1 | 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. |
| Primary | Intra-observer measurement precision (Technical Error of Measurement, TEM) | Day 1 | 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. |
| Primary | Agreement between laser device and ShorrBoard height/length measurements | Day 1 | 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. |
| Primary | Reliability and concordance of height/length measurements | Day 1 | 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. |
| Secondary | Measurement accuracy by measurer cadre | Day 1 | 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. |
| Secondary | Differences between expert and community volunteer measurements | Day 1 | 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. |
| Secondary | Device-by-measurer interaction | Day 1 | 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. |
| Secondary | Differences in anthropometric z-scores | During a single study visit; repeated measurements with both devices are obtained at least 30 minutes apart | 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. |
| Secondary | Agreement in stunting classification | Day 1 | 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. |
| Secondary | Agreement in wasting classification | Day 1 | 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. |
| Secondary | Differences in estimated prevalence of stunting and wasting | Day 1 | 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. |
| Other | Measurement accuracy and precision by age group | Day 1 to Day 7 | 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). |
| Other | Measurement accuracy across child stature | Day 1 to Day 7 | 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. |
| Other | Variability in measurement differences | Day 1 to Day 7 | 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. |
| Other | Frequency of requiring a third measurement | Day 1 | 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. |
| Other | Measurement errors and protocol adherence | Day 1 to Day 7 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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