Back to resultsRole of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study (POWELL)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multidisciplinary weight loss
Sponsored by
About this trial
This is an interventional basic science trial for Pediatric Obesity focused on measuring energy expenditure, weight loss, obesity, adolescents
Eligibility Criteria
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
Sites / Locations
- CHU clermont-ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adolescents with obesity
Arm Description
Adolescents with obesity aged 12-16 years old
Outcomes
Primary Outcome Measures
Change in Energy Expenditure between before and after weight loss
amount of energy expended during the walking tests, measured using indirect calorimetry
Secondary Outcome Measures
change in lipid oxidation between before and after weight loss
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
change in Fat mass between before and after weight loss
The amount of body fat will be assessed by dual energy X-ray absorptiometry
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)
Change in Energy Expenditure between the unloaded and loaded walking test
amount of energy expended during the walking tests, measured using indirect calorimetry
Change in lipid oxidation between the unloaded and loaded walking test
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
Full Information
NCT ID
NCT04902001
First Posted
May 3, 2021
Last Updated
June 2, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04902001
Brief Title
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
Acronym
POWELL
Official Title
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
energy expenditure, weight loss, obesity, adolescents
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group of adolescents with obesity
Masking
None (Open Label)
Masking Description
There is no need for masking here.
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescents with obesity
Arm Type
Experimental
Arm Description
Adolescents with obesity aged 12-16 years old
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary weight loss
Intervention Description
The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.
Primary Outcome Measure Information:
Title
Change in Energy Expenditure between before and after weight loss
Description
amount of energy expended during the walking tests, measured using indirect calorimetry
Time Frame
before and after the 12-week weight loss
Secondary Outcome Measure Information:
Title
change in lipid oxidation between before and after weight loss
Description
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
Time Frame
before and after the 12-week weight loss
Title
change in Fat mass between before and after weight loss
Description
The amount of body fat will be assessed by dual energy X-ray absorptiometry
Time Frame
before and after the 12-week weight loss
Title
change physical activity preferences between before and after weight loss
Description
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)
Time Frame
before and after the 12-week weight loss intervention
Title
Change in Energy Expenditure between the unloaded and loaded walking test
Description
amount of energy expended during the walking tests, measured using indirect calorimetry
Time Frame
after the 12_week weight loss
Title
Change in lipid oxidation between the unloaded and loaded walking test
Description
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
Time Frame
after the 12_week weight loss
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Boirie
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Learn more about this trial
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
We'll reach out to this number within 24 hrs