Validation of the Mercy TAPE (TAPE)
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ClinicalTrials.gov Identifier: NCT01507090 |
Recruitment Status :
Completed
First Posted : January 10, 2012
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
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Condition or disease | Intervention/treatment |
---|---|
Weight | Device: Mercy TAPE |

Study Type : | Observational |
Actual Enrollment : | 642 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Taking the Guesswork Out of Pediatric Weight Estimation (TAPE): Validation of the Mercy TAPE |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | April 2012 |
Group/Cohort | Intervention/treatment |
---|---|
Normal Children
Otherwise healthy children 2 months to 16 years of age.
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Device: Mercy TAPE
2D Mercy TAPE and 3D Mercy TAPE |
- Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.
- Predictive Performance of the Mercy TAPE (Slope) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.
- Predictive Performance of the Mercy TAPE (Intercept) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.
- Predictive Performance of the Mercy TAPE (Mean Error) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)
- Predictive Performance of the Mercy TAPE (Mean Percentage Error) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)
- Predictive Performance of the Mercy TAPE (Corelation Coefficient) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)
- Predictive Performance of the Mercy TAPE [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)
- Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.
- Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.
- Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%) [ Time Frame: study day 1 ]Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.
- Inter-rater Reliability for the 2D and 3D Mercy TAPEs. [ Time Frame: study day 1 ]Intraclass correlation coefficient
- Device Print Batch Variability [ Time Frame: study day 1 ]Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers "1" and "2" accordingly.
- Predictive Performance of the Mercy Method (Intercept) [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)
- Predictive Performance of the Mercy Method (Slope) [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)
- Predictive Performance of the Mercy Method (Percent of Participants) [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.
- Predictive Performance of the Mercy Method (Mean Error) [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)
- Predictive Performance of the Mercy Method (Mean Percentage Error) [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)
- Predictive Performance of the Mercy Method [ Time Frame: study day 1 ]Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

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Ages Eligible for Study: | 2 Months to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- age between 2 months and 16 years of age
- capable of having the measurements performed
- parent or legal guardian is willing and able to provide verbal permission and, when appropriate, the participant has provided verbal assent to participate.
Exclusion Criteria:
- unwilling to participate in the study procedures
- known or apparent limb deformities
- presence of any external medical equipment attached to the child
- underlying pathological condition that would produce abnormal body composition for age (e.g. edema)
- underlying pharmacologic management that would produce abnormal body composition for age (e.g. chronic oral corticosteroid use)
- In the opinion of the physicians providing patient care and those conducting the study, there are real or perceived contraindications for inclusion as a participant in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507090
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72202 | |
United States, Missouri | |
Children's Mercy Hospital and Clinics | |
Kansas City, Missouri, United States, 64108 | |
United States, Pennsylvania | |
Milton Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Susan Abdel-Rahman, Pharm.D | Childrens Mercy Hospital |
Responsible Party: | Susan Abdel-Rahman, Professor of Pediatrics, Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT01507090 |
Other Study ID Numbers: |
Mercy TAPE |
First Posted: | January 10, 2012 Key Record Dates |
Results First Posted: | February 10, 2015 |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
children for whom there is no scale to determine weight |
Body Weight |