ObesityCalValNCT01776944
Resting Energy Expenditure Using a Handheld Calorimeter
An observational study of Obesity, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Obesity
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Obese children aged 13-18y of both gender
Who may be able to join
- 13-18y of age
- BMI 85th percentile or more
- No severe illness, neurological and development issues
- not on insulin
- Able to fast overnight
Who cannot join
- not 13-18y of age
- BMI under 85th percentile
- ill or have neurological and development issues
- on insulin
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Validating a Handheld Indirect Calorimeter in Overweight and Obese Pediatric Population
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.
- Conditions
- Obesity
- Keywords
- Resting energy expenditure, Handheld calorimeter, Obese and overweight, Pediatrics
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, Ph.D, Principal investigator, Child & Family Research Institute/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776944
- Sponsor's protocol ID
- H12-00364
- Acronym
- CalVal
- Status last verified
- Jul 2017
- First submitted
- 17 Jan 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27653085
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a Handheld Indirect Calorimeter in Overweight and Obese Pediatric Population
- ClinicalTrials.gov ID
- NCT01776944
- Acronym / sponsor ID
- CalVal / H12-00364
- Conditions
- Obesity
- Keywords
- Resting energy expenditure, Handheld calorimeter, Obese and overweight, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese children | – | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Obese children aged 13-18y of both gender
Key inclusion criteria (5 listed)
- 13-18y of age
- BMI 85th percentile or more
- No severe illness, neurological and development issues
- not on insulin
- Able to fast overnight
Key exclusion criteria (4 listed)
- not 13-18y of age
- BMI under 85th percentile
- ill or have neurological and development issues
- on insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 27653085Woo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajavel Elango, Ph.D principal investigator
Child & Family Research Institute/University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.