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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Time frame: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Time frame: Day 0
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
Time frame: Day 0
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
Time frame: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Time frame: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Time frame: Day 0
left myocardial regional function
left myocardial regional function (echocardiography)
Time frame: Month 3
left myocardial regional function
left myocardial regional function (MRI)
Time frame: Month 3
left myocardial regional function
left myocardial regional function (echocardiography)
Time frame: Day 0
left myocardial regional function
left myocardial regional function (MRI)
Time frame: Day 0
macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Time frame: Day 0
macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Time frame: Month 3
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Time frame: Month 3
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Time frame: Day 0
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Time frame: Day 0
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Time frame: Month 3
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
Time frame: Month 3
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
Time frame: Day 0
microvascularisation
measure of microvascular perfusion using flowmotion
Time frame: Day 0
microvascularisation
measure of microvascular perfusion using flowmotion
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Time frame: Month 3
heart rate variability
measure of heart rate variability using a holter
Time frame: Month 3
heart rate variability
measure of heart rate variability using a holter
Time frame: Day 0
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
Time frame: Day 0
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
Time frame: Month 3
Liver steatosis
measure of liver steatosis by MRI
Time frame: Month 3
Liver steatosis
measure of liver steatosis by MRI
Time frame: Day 0
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Time frame: Day 0
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Time frame: Month 3
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Time frame: month 3
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Time frame: Day 0
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Time frame: Day 0
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Time frame: Month 3
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Time frame: Month 3
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Time frame: Day 0
blood pressure
measure of blood pressure using sphygmomanometer
Time frame: Day0
blood pressure
measure of blood pressure using sphygmomanometer
Time frame: month 3
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.
Time frame: Month 3
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.
Time frame: Day 0
muscle mass
measure of muscle mass using impedancemeter
Time frame: Month 3
fat mass
measure of muscle mass using impedancemeter
Time frame: Month 3
bone structure
measure of muscle mass using impedancemeter
Time frame: Month 3
muscle mass
measure of muscle mass using impedancemeter
Time frame: Day 0
fat mass
measure of muscle mass using impedancemeter
Time frame: Day 0
bone structure
measure of muscle mass using impedancemeter
Time frame: Day 0
muscle mass
measure of muscle mass using Densitometry X-ray absorption
Time frame: Day 0
fat mass
measure of muscle mass using Densitometry X-ray absorption
Time frame: Day 0
bone structure
measure of muscle mass using Densitometry X-ray absorption
Time frame: Day 0
muscle mass
measure of muscle mass using Densitometry X-ray absorption
Time frame: Month 3
fat mass
measure of muscle mass using Densitometry X-ray absorption
Time frame: Month 3
bone structure
measure of muscle mass using Densitometry X-ray absorption
Time frame: Month 3
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Month 3
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Month 3
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Month 3
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Day 0
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Day 0
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Time frame: Day 0
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Day 0
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Day 0
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Day 0
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Month 3
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Month 3
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
Time frame: Month 3
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".
Time frame: Day 0
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".
Time frame: Month 3
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"
Time frame: Day 0
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"
Time frame: Month 3
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Time frame: Day 0
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Time frame: Month 3
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time frame: day 0
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time frame: Month 3
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time frame: Day 0
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Time frame: Month 3
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".
Time frame: day 0
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".
Time frame: Month 3
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".
Time frame: day 0
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".
Time frame: Month 3
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)
Time frame: Day 0
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)
Time frame: Month 3
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Time frame: Day 0
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Time frame: Month 3
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)
Time frame: Day 0
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)
Time frame: Month 3
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).
Time frame: Day 0
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).
Time frame: Month 3
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Time frame: Day 0
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Time frame: Month 3
Alexithymia
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
Alexithymia
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
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Time frame: Day 0
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Time frame: Month 3
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time frame: Day 0
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time frame: Month 3
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 frame: Day 0
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 frame: Month 3
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Time frame: Day 0
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Time frame: Month 3
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Time frame: Day 0
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Time frame: Month 3
cholesterol
measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
triglycerides
measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
cholesterol
measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
triglycerides
measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
Time frame: day 0
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
BDNF
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
BDNF
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
CRP
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
CRP
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
NPY
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Month 3
NPY
proteins measure by blood analyses to evaluate alloplastic load
Time frame: Day 0
Leptin
measure by blood analyses to evaluate appetite regulation
Time frame: Day 0
Leptin
measure by blood analyses to evaluate appetite regulation
Time frame: Month 3
Ghrelin
measure by blood analyses to evaluate appetite regulation
Time frame: Day 0
Ghrelin
measure by blood analyses to evaluate appetite regulation
Time frame: Month 3
NPY
measure by blood analyses to evaluate appetite regulation
Time frame: day 0
NPY
measure by blood analyses to evaluate appetite regulation
Time frame: Month 3
adiponectine
measure by blood analyses to evaluate appetite regulation
Time frame: Day 0
adiponectine
measure by blood analyses to evaluate appetite regulation
Time frame: Month 3
CCK
measure by blood analyses to evaluate appetite regulation
Time frame: Day 0
Month 3
measure by blood analyses to evaluate appetite regulation
Time frame: Day 0
Insulin
measure by blood analyses to evaluate glucid metabolism
Time frame: Day 0
Insulin
measure by blood analyses to evaluate glucid metabolism
Time frame: Month 3
HbA1c
measure by blood analyses to evaluate glucid metabolism
Time frame: Day 0
HbA1c
measure by blood analyses to evaluate glucid metabolism
Time frame: Month 3
glucose
measure by blood analyses to evaluate glucid metabolism
Time frame: Day 0
glucose
measure by blood analyses to evaluate glucid metabolism
Time frame: Month 3
Albumin
measure by blood analyses to evaluate protid metabolism
Time frame: Day 0
Albumin
measure by blood analyses to evaluate protid metabolism
Time frame: Month 3
transthyretin
measure by blood analyses to evaluate protid metabolism
Time frame: Day 0
transthyretin
measure by blood analyses to evaluate protid metabolism
Time frame: Month 3
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Time frame: Day 0
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Time frame: Month 3
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Time frame: Day 0
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Time frame: Month 3
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Time frame: Day 0
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Time frame: Month 3
VEGF
measure by blood analyses to evaluate cardiovascular function
Time frame: Day 0
VEGF
measure by blood analyses to evaluate cardiovascular function
Time frame: Month 3
PAI1
measure by blood analyses to evaluate cardiovascular function
Time frame: Day 0
PAI1
measure by blood analyses to evaluate cardiovascular function
Time frame: Month 3
weight
measure of weight in kilograms
Time frame: Day 0
weight
measure of weight in kilograms
Time frame: Month 3
waist circumference
measure of waist circumference in centimetres
Time frame: Day 0
waist circumference
measure of waist circumference in centimetres
Time frame: Month 3