Pedicatric Obesity - Weight - Energy - Loss - Load

NCT06085040 | Not Yet Recruiting

• 1 other identifier: RBHP 2023 BOIRIE 2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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; 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".

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (2)

• Body Weight

  The adolescents weight will be assessed

  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

  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

  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

  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

  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

  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

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Multidisciplinary weight loss

Interventions

Multidisciplinary weight loss BEHAVIORAL

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)

Intervention

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Yves Boirie

CONTACT

yboirie@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 16, 2023
• Study Start: October 30, 2023
• Primary Completion: June 25, 2024
• Study Completion (Estimated): June 25, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

FR (1)