Status:
NOT_YET_RECRUITING
Pedicatric Obesity - Weight - Energy - Loss - Load
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Pediatric Obesity
Eligibility:
All Genders
12-16 years
Phase:
NA
Brief 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; m...
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 afte...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06085040
Start Date
October 30 2023
End Date
June 25 2026
Last Update
October 23 2023
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France