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Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX) (CARDIBOX)

Primary Purpose

Obesity, Adolescent Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3-month lifestyle intervention
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring left myocardial regional function, cardiac ectopic fat deposits, lifestyle programm, prevention, Adolescent Obesity

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 12 and 16 years old
  • mature (menarche)
  • suitable for physical activity
  • able to give an informative consent
  • affiliated at French insurance company
  • consent from the legal representatives
  • For obese adolescents: BMI greater than the 97th percentile of national curves.
  • For the control group: to be normal-weighted (no obesity if overweight, <85th percentile of national curves).

Exclusion Criteria:

  • Medical or surgical history judged by the investigator as incompatible with the study
  • Drugs that may interfere with the study results
  • Cardiovascular, hepatic, psychiatric, renal, or endocrinological diseases
  • Smoking
  • Alcohol consumption
  • Intense physical activity in competition

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Obese adolescents

Control group

Arm Description

BMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention

to be normal-weighted (no obesity if overweight, <85th percentile of national curves).

Outcomes

Primary Outcome Measures

cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
left myocardial regional function
left myocardial regional function (echocardiography)
left myocardial regional function
left myocardial regional function (MRI)
left myocardial regional function
left myocardial regional function (echocardiography)
left myocardial regional function
left myocardial regional function (MRI)

Secondary Outcome Measures

macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
microvascularisation
measure of microvascular perfusion using flowmotion
microvascularisation
measure of microvascular perfusion using flowmotion
heart rate variability
measure of heart rate variability using a holter
heart rate variability
measure of heart rate variability using a holter
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
Liver steatosis
measure of liver steatosis by MRI
Liver steatosis
measure of liver steatosis by MRI
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
blood pressure
measure of blood pressure using sphygmomanometer
blood pressure
measure of blood pressure using sphygmomanometer
Fitness
6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.
Fitness
6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.
muscle mass
measure of muscle mass using impedancemeter
fat mass
measure of muscle mass using impedancemeter
bone structure
measure of muscle mass using impedancemeter
muscle mass
measure of muscle mass using impedancemeter
fat mass
measure of muscle mass using impedancemeter
bone structure
measure of muscle mass using impedancemeter
muscle mass
measure of muscle mass using Densitometry X-ray absorption
fat mass
measure of muscle mass using Densitometry X-ray absorption
bone structure
measure of muscle mass using Densitometry X-ray absorption
muscle mass
measure of muscle mass using Densitometry X-ray absorption
fat mass
measure of muscle mass using Densitometry X-ray absorption
bone structure
measure of muscle mass using Densitometry X-ray absorption
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
depression
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
depression
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
anxiety
anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"
anxiety
anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Sleep
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Sleep
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Burnout
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Burnout
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Mindfulness
Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
Mindfulness
Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Emotions
Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Emotions
Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Perception of work
Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).
Perception of work
Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Alexithymia
Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".
Alexithymia
Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time perception
Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".
Time perception
Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
cholesterol
measure by blood analyses to evaluate alloplastic load
triglycerides
measure by blood analyses to evaluate alloplastic load
cholesterol
measure by blood analyses to evaluate alloplastic load
triglycerides
measure by blood analyses to evaluate alloplastic load
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
BDNF
proteins measure by blood analyses to evaluate alloplastic load
BDNF
proteins measure by blood analyses to evaluate alloplastic load
CRP
proteins measure by blood analyses to evaluate alloplastic load
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
CRP
proteins measure by blood analyses to evaluate alloplastic load
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
NPY
proteins measure by blood analyses to evaluate alloplastic load
NPY
proteins measure by blood analyses to evaluate alloplastic load
Leptin
measure by blood analyses to evaluate appetite regulation
Leptin
measure by blood analyses to evaluate appetite regulation
Ghrelin
measure by blood analyses to evaluate appetite regulation
Ghrelin
measure by blood analyses to evaluate appetite regulation
NPY
measure by blood analyses to evaluate appetite regulation
NPY
measure by blood analyses to evaluate appetite regulation
adiponectine
measure by blood analyses to evaluate appetite regulation
adiponectine
measure by blood analyses to evaluate appetite regulation
CCK
measure by blood analyses to evaluate appetite regulation
Month 3
measure by blood analyses to evaluate appetite regulation
Insulin
measure by blood analyses to evaluate glucid metabolism
Insulin
measure by blood analyses to evaluate glucid metabolism
HbA1c
measure by blood analyses to evaluate glucid metabolism
HbA1c
measure by blood analyses to evaluate glucid metabolism
glucose
measure by blood analyses to evaluate glucid metabolism
glucose
measure by blood analyses to evaluate glucid metabolism
Albumin
measure by blood analyses to evaluate protid metabolism
Albumin
measure by blood analyses to evaluate protid metabolism
transthyretin
measure by blood analyses to evaluate protid metabolism
transthyretin
measure by blood analyses to evaluate protid metabolism
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
VEGF
measure by blood analyses to evaluate cardiovascular function
VEGF
measure by blood analyses to evaluate cardiovascular function
PAI1
measure by blood analyses to evaluate cardiovascular function
PAI1
measure by blood analyses to evaluate cardiovascular function
weight
measure of weight in kilograms
weight
measure of weight in kilograms
waist circumference
measure of waist circumference in centimetres
waist circumference
measure of waist circumference in centimetres

Full Information

First Posted
February 10, 2020
Last Updated
March 13, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France, LaPEC laboratory (EA 4278), University of Avignon, Avignon, France, Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France, Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France
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1. Study Identification

Unique Protocol Identification Number
NCT04310371
Brief Title
Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)
Acronym
CARDIBOX
Official Title
Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France, LaPEC laboratory (EA 4278), University of Avignon, Avignon, France, Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France, Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The high prevalence of childhood obesity is a major public health issue, worldwide. Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities. This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.
Detailed Description
The investigators aim to improve knowledge of the association between epicardial adipose tissue, myocardial lipid content, and left ventricular regional myocardial function. In this protocol, obese adolescents are recruited undergoing a 3-month lifestyle intervention residential program. Adolescents from the intervention group will be enrolled at the obesity center for the whole school year. The obesity center employs a multidisciplinary team to provide the best weight management care to adolescents during their stay. The weight loss program is an integral part of the obesity center program and fundamentally combines physical activity with a normocaloric diet monitored by a dietician. The physical activity program consists of two training sessions (aerobic and resistance training) per week. Moreover, adolescents will be engaged in two additional sessions per week, consisting in recreational activities such as ball and racquet games, trekking, snowshoeing or swimming. There will be two measurement time: one at baseline (Day 0) and one at three months after the beginning of the lifestyle intervention (M3). The controls will be evaluated at baseline only. Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, mean standard deviation or median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results. The main analysis will be performed with the Stata software (version 13, StataCorp, College Station). All statistical tests will be carried out at a risk of error of first species α set at 5%. Most of the analysis of the secondary evaluation criteria will be exploratory in nature and may lack power in terms of numbers. As discussed by Feise in 2002,104 the adjustment of the risk of error of 1st species will not be systematically proposed, but case by case in view of clinical considerations and not only statistical (e.g. Sidak correction for the analysis of correlation coefficients). Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of standard deviation or mean median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results. Intergroup comparisons will be systematically conducted without adjustment and by adjusting for factors whose distribution could be unbalanced between groups. Patients will be described and compared between groups at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and characteristics of possible treatments. The baseline comparability of the two groups will be assessed on the main characteristics of the participants and potential factors associated with the primary outcome. A possible difference between the two groups on one of these characteristics will be determined according to clinical considerations and not solely statistical ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent Obesity
Keywords
left myocardial regional function, cardiac ectopic fat deposits, lifestyle programm, prevention, Adolescent Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants receive an intervention throughout the protocol
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obese adolescents
Arm Type
Experimental
Arm Description
BMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
Intervention Type
Behavioral
Intervention Name(s)
3-month lifestyle intervention
Intervention Description
Adolescents from the intervention group will be enrolled at the obesity center for the whole school year (i.e., 10 months). The physical activity program consists of two training sessions (aerobic and resistance training) per week. There will be two measurement time: one at baseline (Day 0) and one at three months after the beginning of the lifestyle intervention (M3). The controls will be evaluated at baseline only.
Primary Outcome Measure Information:
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Time Frame
Month 3
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Time Frame
Day 0
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (volume using MRI)
Time Frame
Day 0
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (volume using MRI)
Time Frame
Month 3
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Time Frame
Month 3
Title
cardiac ectopic fat deposits
Description
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Time Frame
Day 0
Title
left myocardial regional function
Description
left myocardial regional function (echocardiography)
Time Frame
Month 3
Title
left myocardial regional function
Description
left myocardial regional function (MRI)
Time Frame
Month 3
Title
left myocardial regional function
Description
left myocardial regional function (echocardiography)
Time Frame
Day 0
Title
left myocardial regional function
Description
left myocardial regional function (MRI)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
macrovascularisation
Description
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Time Frame
Day 0
Title
macrovascularisation
Description
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Time Frame
Month 3
Title
microvascularisation
Description
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Time Frame
Month 3
Title
microvascularisation
Description
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Time Frame
Day 0
Title
microvascularisation
Description
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Time Frame
Day 0
Title
microvascularisation
Description
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Time Frame
Month 3
Title
microvascularisation
Description
measure of microvascular perfusion using Iontophoresis procedure
Time Frame
Month 3
Title
microvascularisation
Description
measure of microvascular perfusion using Iontophoresis procedure
Time Frame
Day 0
Title
microvascularisation
Description
measure of microvascular perfusion using flowmotion
Time Frame
Day 0
Title
microvascularisation
Description
measure of microvascular perfusion using flowmotion
Time Frame
Month 3
Title
heart rate variability
Description
measure of heart rate variability using a holter
Time Frame
Month 3
Title
heart rate variability
Description
measure of heart rate variability using a holter
Time Frame
Day 0
Title
skin conductance
Description
measure of skin conductance using Wristband electrodes - Empatica E4
Time Frame
Day 0
Title
skin conductance
Description
measure of skin conductance using Wristband electrodes - Empatica E4
Time Frame
Month 3
Title
Liver steatosis
Description
measure of liver steatosis by MRI
Time Frame
Month 3
Title
Liver steatosis
Description
measure of liver steatosis by MRI
Time Frame
Day 0
Title
Liver steatosis
Description
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Time Frame
Day 0
Title
Liver steatosis
Description
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Time Frame
Month 3
Title
Liver steatosis
Description
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Time Frame
month 3
Title
Liver steatosis
Description
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Time Frame
Day 0
Title
Liver fibrosis
Description
measure of liver fibrosis by fibroscanner (liver stiffness)
Time Frame
Day 0
Title
Liver fibrosis
Description
measure of liver fibrosis by fibroscanner (liver stiffness)
Time Frame
Month 3
Title
Liver fibrosis
Description
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Time Frame
Month 3
Title
Liver fibrosis
Description
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Time Frame
Day 0
Title
blood pressure
Description
measure of blood pressure using sphygmomanometer
Time Frame
Day0
Title
blood pressure
Description
measure of blood pressure using sphygmomanometer
Time Frame
month 3
Title
Fitness
Description
6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.
Time Frame
Month 3
Title
Fitness
Description
6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.
Time Frame
Day 0
Title
muscle mass
Description
measure of muscle mass using impedancemeter
Time Frame
Month 3
Title
fat mass
Description
measure of muscle mass using impedancemeter
Time Frame
Month 3
Title
bone structure
Description
measure of muscle mass using impedancemeter
Time Frame
Month 3
Title
muscle mass
Description
measure of muscle mass using impedancemeter
Time Frame
Day 0
Title
fat mass
Description
measure of muscle mass using impedancemeter
Time Frame
Day 0
Title
bone structure
Description
measure of muscle mass using impedancemeter
Time Frame
Day 0
Title
muscle mass
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Day 0
Title
fat mass
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Day 0
Title
bone structure
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Day 0
Title
muscle mass
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Month 3
Title
fat mass
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Month 3
Title
bone structure
Description
measure of muscle mass using Densitometry X-ray absorption
Time Frame
Month 3
Title
muscle mass
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Month 3
Title
fat mass
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Month 3
Title
bone structure
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Month 3
Title
muscle mass
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Day 0
Title
fat mass
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Day 0
Title
bone structure
Description
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time Frame
Day 0
Title
muscle mass
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Day 0
Title
fat mass
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Day 0
Title
bone structure
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Day 0
Title
muscle mass
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Month 3
Title
fat mass
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Month 3
Title
bone structure
Description
measure of muscle mass using Quantitative ultrasounds (QUS)
Time Frame
Month 3
Title
depression
Description
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
Time Frame
Day 0
Title
depression
Description
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
Time Frame
Month 3
Title
anxiety
Description
anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"
Time Frame
Day 0
Title
anxiety
Description
anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"
Time Frame
Month 3
Title
General health
Description
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Time Frame
Day 0
Title
General health
Description
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Time Frame
Month 3
Title
Stress
Description
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time Frame
day 0
Title
Stress
Description
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time Frame
Month 3
Title
Fatigue
Description
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time Frame
Day 0
Title
Fatigue
Description
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time Frame
Month 3
Title
Sleep
Description
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Time Frame
day 0
Title
Sleep
Description
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Time Frame
Month 3
Title
Burnout
Description
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Time Frame
day 0
Title
Burnout
Description
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Time Frame
Month 3
Title
Mindfulness
Description
Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
Time Frame
Day 0
Title
Mindfulness
Description
Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
Time Frame
Month 3
Title
Coping
Description
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Time Frame
Day 0
Title
Coping
Description
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Time Frame
Month 3
Title
Emotions
Description
Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Time Frame
Day 0
Title
Emotions
Description
Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Time Frame
Month 3
Title
Perception of work
Description
Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).
Time Frame
Day 0
Title
Perception of work
Description
Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).
Time Frame
Month 3
Title
Self-efficacy
Description
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Time Frame
Day 0
Title
Self-efficacy
Description
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Time Frame
Month 3
Title
Alexithymia
Description
Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".
Time Frame
Day 0
Title
Alexithymia
Description
Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".
Time Frame
Month 3
Title
Illness perception
Description
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Time Frame
Day 0
Title
Illness perception
Description
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Time Frame
Month 3
Title
Metacognition
Description
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time Frame
Day 0
Title
Metacognition
Description
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time Frame
Month 3
Title
Time perception
Description
Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".
Time Frame
Day 0
Title
Time perception
Description
Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".
Time Frame
Month 3
Title
Physical activity
Description
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Time Frame
Day 0
Title
Physical activity
Description
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Time Frame
Month 3
Title
Life style
Description
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Time Frame
Day 0
Title
Life style
Description
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Time Frame
Month 3
Title
cholesterol
Description
measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
triglycerides
Description
measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
cholesterol
Description
measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
triglycerides
Description
measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
Cortisol
Description
hormone measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
Cortisol
Description
hormone measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
DHEAS
Description
hormone measure by blood analyses to evaluate alloplastic load
Time Frame
day 0
Title
DHEAS
Description
hormone measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
BDNF
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
BDNF
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
CRP
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
pro-inflammatory cytokines
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
TNF alpha
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
CRP
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
pro-inflammatory cytokines
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
TNF alpha
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
NPY
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Month 3
Title
NPY
Description
proteins measure by blood analyses to evaluate alloplastic load
Time Frame
Day 0
Title
Leptin
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Day 0
Title
Leptin
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Month 3
Title
Ghrelin
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Day 0
Title
Ghrelin
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Month 3
Title
NPY
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
day 0
Title
NPY
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Month 3
Title
adiponectine
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Day 0
Title
adiponectine
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Month 3
Title
CCK
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Day 0
Title
Month 3
Description
measure by blood analyses to evaluate appetite regulation
Time Frame
Day 0
Title
Insulin
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Day 0
Title
Insulin
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Month 3
Title
HbA1c
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Day 0
Title
HbA1c
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Month 3
Title
glucose
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Day 0
Title
glucose
Description
measure by blood analyses to evaluate glucid metabolism
Time Frame
Month 3
Title
Albumin
Description
measure by blood analyses to evaluate protid metabolism
Time Frame
Day 0
Title
Albumin
Description
measure by blood analyses to evaluate protid metabolism
Time Frame
Month 3
Title
transthyretin
Description
measure by blood analyses to evaluate protid metabolism
Time Frame
Day 0
Title
transthyretin
Description
measure by blood analyses to evaluate protid metabolism
Time Frame
Month 3
Title
Homeostasis
Description
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Time Frame
Day 0
Title
Homeostasis
Description
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Time Frame
Month 3
Title
Osteoresorption
Description
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Time Frame
Day 0
Title
Osteoresorption
Description
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Time Frame
Month 3
Title
Osteoformation
Description
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Time Frame
Day 0
Title
Osteoformation
Description
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Time Frame
Month 3
Title
VEGF
Description
measure by blood analyses to evaluate cardiovascular function
Time Frame
Day 0
Title
VEGF
Description
measure by blood analyses to evaluate cardiovascular function
Time Frame
Month 3
Title
PAI1
Description
measure by blood analyses to evaluate cardiovascular function
Time Frame
Day 0
Title
PAI1
Description
measure by blood analyses to evaluate cardiovascular function
Time Frame
Month 3
Title
weight
Description
measure of weight in kilograms
Time Frame
Day 0
Title
weight
Description
measure of weight in kilograms
Time Frame
Month 3
Title
waist circumference
Description
measure of waist circumference in centimetres
Time Frame
Day 0
Title
waist circumference
Description
measure of waist circumference in centimetres
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 12 and 16 years old mature (menarche) suitable for physical activity able to give an informative consent affiliated at French insurance company consent from the legal representatives For obese adolescents: BMI greater than the 97th percentile of national curves. For the control group: to be normal-weighted (no obesity if overweight, <85th percentile of national curves). Exclusion Criteria: Medical or surgical history judged by the investigator as incompatible with the study Drugs that may interfere with the study results Cardiovascular, hepatic, psychiatric, renal, or endocrinological diseases Smoking Alcohol consumption Intense physical activity in competition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Dutheil
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Dutheil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)

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