Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study (POWELL)

June 2, 2022 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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

  • France
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand

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

12 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adolescents with obesity
Adolescents with obesity aged 12-16 years old
Behavioral: Multidisciplinary weight loss
The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Energy Expenditure between before and after weight loss
Time Frame: before and after the 12-week weight loss
amount of energy expended during the walking tests, measured using indirect calorimetry
before and after the 12-week weight loss

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in lipid oxidation between before and after weight loss
Time Frame: before and after the 12-week weight loss
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
before and after the 12-week weight loss
change in Fat mass between before and after weight loss
Time Frame: before and after the 12-week weight loss
The amount of body fat will be assessed by dual energy X-ray absorptiometry
before and after the 12-week weight loss
change physical activity preferences between before and after weight loss
Time Frame: before and after the 12-week weight loss intervention
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
Change in Energy Expenditure between the unloaded and loaded walking test
Time Frame: after the 12_week weight loss
amount of energy expended during the walking tests, measured using indirect calorimetry
after the 12_week weight loss
Change in lipid oxidation between the unloaded and loaded walking test
Time Frame: after the 12_week weight loss
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
after the 12_week weight loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

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 (ACTUAL)

August 20, 2021

Primary Completion (ACTUAL)

April 25, 2022

Study Completion (ACTUAL)

April 25, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (ACTUAL)

May 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2021 BOIRIE
  • 2021-A00756-35 (OTHER: 2021-A00756-35)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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