Pediatric ObesityPOWELLNCT04902001
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
A study testing Multidisciplinary weight loss in people with Pediatric Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Multidisciplinary weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2021to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Multidisciplinary weight loss
- Keywords
- energy expenditure, weight loss, obesity, adolescents
- Medical subject headings
- Pediatric Obesity, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary weight lossBehavioural
The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with obesity | Experimental | Adolescents with obesity aged 12-16 years old Receives: Behavioral: Multidisciplinary weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energy Expenditure between before and after weight loss
amount of energy expended during the walking tests, measured using indirect calorimetry
Measured: before and after the 12-week weight loss
Secondary outcomes (5)
change in lipid oxidation between before and after weight loss
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
Measured: before and after the 12-week weight loss
change in Fat mass between before and after weight loss
The amount of body fat will be assessed by dual energy X-ray absorptiometry
Measured: before and after the 12-week weight loss
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)
Measured: before and after the 12-week weight loss intervention
Change in Energy Expenditure between the unloaded and loaded walking test
amount of energy expended during the walking tests, measured using indirect calorimetry
Measured: after the 12_week weight loss
Change in lipid oxidation between the unloaded and loaded walking test
amount of lipids oxidized during the walking tests, measured using indirect calorimetry
Measured: after the 12_week weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start20 Aug 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of adolescents with obesity
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902001
- Sponsor's protocol ID
- RBHP 2021 BOIRIE
- Other IDs
- 2021-A00756-35
- Acronym
- POWELL
- Status last verified
- Jul 2026
- First submitted
- 3 May 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thivel D, Ennequin G, Lambert C, Siroux J, Ratel S, Boscaro A, Pelissier L, Julian V, Cardenoux C, Duclos M, Lazzer S, Pereira B, Boirie Y, Isacco L. Improved walking energy efficiency might persist in presence of simulated full weight regain after multidisciplinary weight loss in adolescents with obesity: the POWELL study. Int J Obes (Lond). 2024 Mar;48(3):384-393. doi: 10.1038/s41366-023-01427-w. Epub 2023 Dec 5.
PubMed 38052874
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
- ClinicalTrials.gov ID
- NCT04902001
- Acronym / sponsor ID
- POWELL / RBHP 2021 BOIRIE
- Conditions
- Pediatric Obesity
- Keywords
- energy expenditure, weight loss, obesity, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of adolescents with obesity
| Arm | Type | Receives |
|---|---|---|
| Adolescents with obesity | Experimental | Behavioral: Multidisciplinary weight lossAdolescents with obesity aged 12-16 years old |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary weight lossThe adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports. | Behavioural | Adolescents with obesity |
Primary outcome
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
5 secondary outcomes
change in lipid oxidation between before and after weight loss
Time frame: 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
change physical activity preferences between before and after weight loss
Time frame: 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
Change in lipid oxidation between the unloaded and loaded walking test
Time frame: after the 12_week weight loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 38052874Thivel D, Ennequin G, Lambert C, Siroux J, Ratel S, Boscaro A, Pelissier L, Julian V, Cardenoux C, Duclos M, Lazzer S, Pereira B, Boirie Y, Isacco L. Improved walking energy efficiency might persist in presence of simulated full weight regain after multidisciplinary weight loss in adolescents with obesity: the POWELL study. Int J Obes (Lond). 2024 Mar;48(3):384-393. doi: 10.1038/s41366-023-01427-w. Epub 2023 Dec 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Boirie principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary weight loss in people with Pediatric Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Energy Expenditure between before and after weight loss (time frame: before and after the 12-week weight loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.