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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01776944
Other study ID # H12-00364
Secondary ID
Status Completed
Phase N/A
First received January 17, 2013
Last updated July 13, 2017
Start date May 2012
Est. completion date February 2015

Study information

Verified date July 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High prevalence of obesity in children has increased associated complications such as type 2 diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts caloric intake by estimating the resting and total daily energy expenditures.Estimation of energy needs is most commonly done using predictive equations. Reliable and valid energy requirements can be obtained using a traditional metabolic system, however this is an expensive option. Handheld indirect calorimeters may be a good alternative to measure energy needs. Several studies have been conducted to determine the validity and accuracy of handheld calorimeters in adults and health children, however, to the best of our knowledge, there are no such studies in the overweight and obese pediatric population.

The purpose of this study is to validate a handheld indirect calorimeter against a traditional metabolic system in overweight and obese children.

If handheld calorimeters can accurately measure resting energy expenditure in overweight and obese adolescents, dietitians will have an opportunity to tailor pediatric weight management interventions based on parameters that are unique to each individual.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- 13-18y of age

- BMI 85th percentile or more

- No severe illness, neurological and development issues

- not on insulin

- Able to fast overnight

Exclusion Criteria:

- not 13-18y of age

- BMI under 85th percentile

- ill or have neurological and development issues

- on insulin

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Child & Family Research Institute Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions 1 hour
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