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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04902001
Other study ID # RBHP 2021 BOIRIE
Secondary ID 2021-A00756-35
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2021
Est. completion date April 25, 2022

Study information

Verified date June 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

While interdisciplinary weight loss intervention have been shown successful among adolescents with obesity, a weight regain is most of the time observed within the following weeks or months. The aim of the present project will be to better identify the independent role played by both the metabolic and mechanical load and their modification during weight loss, on the energy expenditure and energy metabolism of adolescents with obesity.


Description:

A total of 28 adolescents with obesity will be recruited from our local inpatient pediatric obesity centers. Before their weight loss intervention the adolescents will complete two experimental visits. During the first visit, anthropometric and body composition measurements will be performed. Then the participants will be asked to complete a walking exercise on a treadmill during the second visit. Their energy expenditure and substrate oxidation will be assessed by indirect calorimetry. They will have to walk at 5 different walking speeds. Then, they will follow a 12-week weight loss intervention. By the end of this intervention, their body composition will be assessed and they will be asked to perform the same walking exercise. On a separate occasion (randomly assigned) they will have to repeat this walking exercise while carrying a load corresponding of their weight loss.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 25, 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria: - being aged 12-16 years old - no contraindication to physical exercise - no cardiovascular disease - BMI above the 97th percentile - candidate to a weight loss intervention Exclusion Criteria: - surgery and medical conditions preventing them to perform the intervention - Weight loss during the previous 6 months - medication that could interfere with energy metabolism. - pregnancy - regular tobacco and alcool use

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multidisciplinary weight loss
The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Energy Expenditure between before and after weight loss amount of energy expended during the walking tests, measured using indirect calorimetry before and after the 12-week weight loss
Secondary change in lipid oxidation between before and after weight loss amount of lipids oxidized during the walking tests, measured using indirect calorimetry before and after the 12-week weight loss
Secondary change in Fat mass between before and after weight loss The amount of body fat will be assessed by dual energy X-ray absorptiometry before and after the 12-week weight loss
Secondary change physical activity preferences between before and after weight loss Children will be asked to indicate their prefered physical activties and sedenatry behaviors on a computer task using visual analog scale (from 0 to 150 mm) before and after the 12-week weight loss intervention
Secondary Change in Energy Expenditure between the unloaded and loaded walking test amount of energy expended during the walking tests, measured using indirect calorimetry after the 12_week weight loss
Secondary Change in lipid oxidation between the unloaded and loaded walking test amount of lipids oxidized during the walking tests, measured using indirect calorimetry after the 12_week weight loss
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