- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107508
The Relationship Between Activity Energy Expenditure and Body Composition in School-age Children
April 9, 2014 updated by: Huijuan Ruan
Obesity is increasing rapidly all over the world not only in adults but also among children.
As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended during physical activity plays an important role in preventing weight gain.
Decreased physical activity, coupled with an over-consumption of calories, lead to the change of body composition by storing energy as fat.Although several studies have simultaneously examined body composition with energy expenditure the independent roles of body composition with activity energy expenditure (AEE) are less firmly established.
It's suspected shrewdly that energy expenditure is partly influenced by the body composition.
The aim of the study is to examine the relation of AEE with body composition in a population of school-age children.
Study Overview
Status
Unknown
Conditions
Detailed Description
Body composition (ie.
FAT% and FFM) will be evaluated by means of bioelectrical impedance analysis (BIA) with Inbody 720 (Biospace, Seoul, South Korea).
Anthropometric dimensions will be recorded for all participants according to standard procedures.
Height will be recorded to the nearest 1.0mm by using a field stadiometer (Seca Corporation, Germany).
FitMate metabolic system (Cosmed, Rome, Italy) will be used to estimate AEE.
Subjects will be tested in a 10-minute submaximal exercise test using the FitMate systems while taking cycling test at 50 Watts on an electrically braked bicycle ergometer.
Each subject will be connected to a calibrated respiratory gas analyzer, a portable metabolic analyzer designed for measurement of oxygen consumption during exercise via a face mask.
Heart rate will be simultaneously measured with the use of a Cosmed wireless HR monitor to track the participant's heart rate level.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Xinhua Hospital
-
Contact:
- Yexuan Tao, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children in Shanghai
Description
Inclusion Criteria:
- Children in Shanghai
Exclusion Criteria:
- cardiovascular disease
- asthma
- severe disease conditions such as cancer and renal failure
- taking steroids (corticosteroids) or antidepressants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: up to 30 days after participating in the study
|
Each participant will be weighted while wearing light clothing, after fasting for at least 4 hours and emptying the bladder.
Body composition, such as body weight, fat mass(FM), fat percentage (FAT%) and free fat mass (FFM) will be measured by bioelectrical impedance analysis(BIA) with Inbody 720 (Biospace, Seoul, South Korea).Body composition measurement will be compared between the normal weight group and overweight/obesity group.
|
up to 30 days after participating in the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
activity energy expenditure (AEE)
Time Frame: up to 30 days after participating in the study
|
Each participant will be asked to perform a cycling test to measure the AEE.
Measurements will be recorded in the early afternoon.
Total AEE (kcal) will be measured in the test.
The exercise time will be adjusted by using the AEE (kcal/min), which was calculated as Total AEE/min.
The weight-adjusted AEE (kcal/kg/min) will be calculated to facilitate comparisons between persons.
AEE will be compared between the overweight/obesity group and normal weight group.
|
up to 30 days after participating in the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qingya Tang, M.D., Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
April 3, 2014
First Submitted That Met QC Criteria
April 3, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Estimate)
April 11, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XHEC-C-2013-021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
University of Alabama at BirminghamCompletedObesity, Childhood | Overweight, ChildhoodUnited States