NCT01776944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

January 17, 2013

Last Update Submit

July 13, 2017

Conditions

Keywords

Resting energy expenditureHandheld calorimeterObese and overweightPediatrics

Outcome Measures

Primary Outcomes (1)

  • Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions

    1 hour

Study Arms (1)

Obese children

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese children aged 13-18y of both gender

You may qualify if:

  • y of age
  • BMI 85th percentile or more
  • No severe illness, neurological and development issues
  • not on insulin
  • Able to fast overnight

You may not qualify if:

  • not 13-18y of age
  • BMI under 85th percentile
  • ill or have neurological and development issues
  • on insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Family Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

  • Woo P, Murthy G, Wong C, Hursh B, Chanoine JP, Elango R. Assessing resting energy expenditure in overweight and obese adolescents in a clinical setting: validity of a handheld indirect calorimeter. Pediatr Res. 2017 Jan;81(1-1):51-56. doi: 10.1038/pr.2016.182. Epub 2016 Sep 21.

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rajavel Elango, Ph.D

    Child & Family Research Institute/University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 28, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

February 1, 2015

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations