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)

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Adolescent Obesity
• Intervention / Treatment: Behavioral: 3-month lifestyle intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese adolescents; BMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention	Behavioral: 3-month lifestyle intervention; 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.
No Intervention: Control group; to be normal-weighted (no obesity if overweight, <85th percentile of national curves).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (thickness using echocardiography)	Month 3
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (thickness using echocardiography)	Day 0
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (volume using MRI)	Day 0
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (volume using MRI)	Month 3
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)	Month 3
cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)	Day 0
left myocardial regional function	left myocardial regional function (echocardiography)	Month 3
left myocardial regional function	left myocardial regional function (MRI)	Month 3
left myocardial regional function	left myocardial regional function (echocardiography)	Day 0
left myocardial regional function	left myocardial regional function (MRI)	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: prevention; left myocardial regional function; cardiac ectopic fat deposits; lifestyle programm; Adolescent Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: RBHP 2019 DUTHEIL; 2019-A01804-53 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No