Pediatric ObesityPOWELL-2NCT06085040
Pedicatric Obesity - Weight - Energy - Loss - Load
A study testing Multidisciplinary weight loss in people with Pediatric Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- 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
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2023to 26 Jun 2026
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects aged 12 to 16 years (maturation 3-5 according to Tanner stages), having a body mass index (BMI) greater than the 97th percentile according to national curves.
- Able to give informed consent (parental authorization and assent of the minor) to participate in the research.
- Person subject to a Social Security system
Who cannot join
- Medical or surgical history judged by the investigator to be incompatible with the study.
- Presence of diabetes, and any other pathology limiting the application of one or the other strategy being tested.
- Subjects currently undergoing energy restriction or a weight loss program through physical activity at the time of inclusion or during the last 6 months.
- Taking medications that may interfere with study results
- Subjects with cardiovascular problems, we are talking here about subjects with a history of cardiovascular and/or neurovascular pathology, as well as subjects presenting cardiovascular and/or neurovascular risk factors (excluding obesity/ overweight).
- Surgical intervention within the previous 3 months.
Show all 16Show fewer
- Pregnant or breastfeeding adolescents
- Person under guardianship/curatorship or safeguard of justice
- Participant's refusal to participate
- Refusal of consent (parental authorization) from holders of parental authority
- Person in period of exclusion from another study
- Consumption of tobacco or alcohol.
- Parents under curatorship/tutorship or legal protection.
- Special diet.
- Participation in regular and intense physical and sporting activities for more than two hours per week.
- Refusal of participation by legal representatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptations métaboliques, énergétiques et Nutritionnelles à la Perte de Poids Chez l'Adolescent Avec obésité : rôle du degré de Perte de Poids. Etude POWELL-2
Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain.
Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences.
Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".
Read the detailed description
After an inclusion visit to ensure the adolescents' ability to complete the entire study, they will then complete 6 experimental visits: i) before their weight loss program (T0); ii) then a visit after a weight loss of 5% (T-5%); iii) after losing 10% of their weight (T-10%); iv) after 12 weeks of treatment (T1); v) after 24 weeks of treatment (T2) and; vi) after 4 months of post-intervention follow-up (T3).
During each of these visits, densitometric (body composition and bone structure) and anthropometric (height, body mass, waist circumference, hip circumference) measurements will be taken. Their resting metabolism as well as their energy consumption during a low-intensity incremental walking exercise will be measured by indirect calorimetry. Their sleep metabolism will be assessed over one night using Dreem headbands and their dietary control assessed during a calibrated test meal (satiety quotients and food reward). Their perception of health and quality of life, as well as the perception of their physical condition and their dietary profiles will be evaluated by questionnaire. The cardiovascular profile will also be assessed by measuring sinus variability, hepatic steatosis, arterial stiffness and the resistance and reactance of the respiratory system. Finally, a fasting blood sample will be taken.
- Conditions
- Pediatric Obesity
- Being tested
- Multidisciplinary weight loss
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary weight lossBehavioural
12-months multidisciplinary behavioral intervention combining physical activity (3 times 60 minutes per week), nutritional guidance (balanced meals) and psychological support (60 minutes per week)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Multidisciplinary weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The adolescents weight will be assessed
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Body composition
Fat Mass and fat Free Mass by absorptiometry
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Secondary outcomes (4)
resting energy expenditure
Energy expenditure during a 20-minute rest using an indirect calorimeter
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Exercise energy expenditure
Energy expenditure during a 20-minute walking exercise using an indirect calorimeter
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Food reward
Liking and wanting for food in the fasted state using a computerized task
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
cardiometabolic profile
Classical fasting blood profile
Measured: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start26 Aug 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2026
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085040
- Sponsor's protocol ID
- RBHP 2023 BOIRIE 2
- Acronym
- POWELL-2
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siroux J, Lambert C, Masurier J, Marcantei C, Tarrit B, Julian V, Dutheil F, De Saint Vincent S, Pereira B, Duclos M, Boirie Y, Isacco L, Thivel D. Resting energetic adaptations over the course of a 10-month multidisciplinary weight loss intervention in adolescents with obesity: The POWELL-2 project. Clin Nutr ESPEN. 2026 Jul 6;75:103463. doi: 10.1016/j.clnesp.2026.103463. Online ahead of print.
PubMed 42409173
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptations métaboliques, énergétiques et Nutritionnelles à la Perte de Poids Chez l'Adolescent Avec obésité : rôle du degré de Perte de Poids. Etude POWELL-2
- ClinicalTrials.gov ID
- NCT06085040
- Acronym / sponsor ID
- POWELL-2 / RBHP 2023 BOIRIE 2
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 16 Oct 2023 (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.
Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain.
Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences.
Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".
Detailed description
After an inclusion visit to ensure the adolescents' ability to complete the entire study, they will then complete 6 experimental visits: i) before their weight loss program (T0); ii) then a visit after a weight loss of 5% (T-5%); iii) after losing 10% of their weight (T-10%); iv) after 12 weeks of treatment (T1); v) after 24 weeks of treatment (T2) and; vi) after 4 months of post-intervention follow-up (T3).
During each of these visits, densitometric (body composition and bone structure) and anthropometric (height, body mass, waist circumference, hip circumference) measurements will be taken. Their resting metabolism as well as their energy consumption during a low-intensity incremental walking exercise will be measured by indirect calorimetry. Their sleep metabolism will be assessed over one night using Dreem headbands and their dietary control assessed during a calibrated test meal (satiety quotients and food reward). Their perception of health and quality of life, as well as the perception of their physical condition and their dietary profiles will be evaluated by questionnaire. The cardiovascular profile will also be assessed by measuring sinus variability, hepatic steatosis, arterial stiffness and the resistance and reactance of the respiratory system. Finally, a fasting blood sample will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multidisciplinary weight loss |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects aged 12 to 16 years (maturation 3-5 according to Tanner stages), having a body mass index (BMI) greater than the 97th percentile according to national curves.
- Able to give informed consent (parental authorization and assent of the minor) to participate in the research.
- Person subject to a Social Security system
Key exclusion criteria (16 listed)
- Medical or surgical history judged by the investigator to be incompatible with the study.
- Presence of diabetes, and any other pathology limiting the application of one or the other strategy being tested.
- Subjects currently undergoing energy restriction or a weight loss program through physical activity at the time of inclusion or during the last 6 months.
- Taking medications that may interfere with study results
- Subjects with cardiovascular problems, we are talking here about subjects with a history of cardiovascular and/or neurovascular pathology, as well as subjects presenting cardiovascular and/or neurovascular risk factors (excluding obesity/ overweight).
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 loss12-months multidisciplinary behavioral intervention combining physical activity (3 times 60 minutes per week), nutritional guidance (balanced meals) and psychological support (60 minutes per week) | Behavioural | Intervention |
Primary outcome
Body Weight
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
The adolescents weight will be assessed
Body composition
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Fat Mass and fat Free Mass by absorptiometry
4 secondary outcomes
resting energy expenditure
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Exercise energy expenditure
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
Food reward
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
cardiometabolic profile
Time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up
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 5 Aug 2026.
- Background: PubMed 42409173Siroux J, Lambert C, Masurier J, Marcantei C, Tarrit B, Julian V, Dutheil F, De Saint Vincent S, Pereira B, Duclos M, Boirie Y, Isacco L, Thivel D. Resting energetic adaptations over the course of a 10-month multidisciplinary weight loss intervention in adolescents with obesity: The POWELL-2 project. Clin Nutr ESPEN. 2026 Jul 6;75:103463. doi: 10.1016/j.clnesp.2026.103463. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 inclusion and 16 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 5 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?
Body Weight (time frame: Before weight loss ; after a 5 and 10 % weight loss, after 6 months of weight loss, after 12 months of weight loss, After a 4-month follow-up). The study lists 2 primary outcomes in all. 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 NCT06085040, 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 5 Aug 2026.