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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02107508
Other study ID # XHEC-C-2013-021
Secondary ID
Status Recruiting
Phase N/A
First received April 3, 2014
Last updated April 9, 2014
Start date January 2013

Study information

Verified date April 2014
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Qingya Tang, MD
Phone +8613761184818
Email tangqingya@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 18 Years
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
China Xinhua Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Huijuan Ruan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary body composition 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 No
Secondary activity energy expenditure (AEE) 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 No
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