Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)
- Conditions
- ObesityAdolescent Obesity
- Interventions
- Behavioral: 3-month lifestyle intervention
- Registration Number
- NCT04310371
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obese adolescents 3-month lifestyle intervention BMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention
- Primary Outcome Measures
Name Time Method cardiac ectopic fat deposits Day 0 Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
left myocardial regional function Day 0 left myocardial regional function (MRI)
- Secondary Outcome Measures
Name Time Method pro-inflammatory cytokines Month 3 proteins measure by blood analyses to evaluate alloplastic load
NPY Month 3 measure by blood analyses to evaluate appetite regulation
Liver fibrosis Day 0 measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Ghrelin Month 3 measure by blood analyses to evaluate appetite regulation
microvascularisation Month 3 measure of microvascular perfusion using flowmotion
heart rate variability Day 0 measure of heart rate variability using a holter
skin conductance Month 3 measure of skin conductance using Wristband electrodes - Empatica E4
macrovascularisation Month 3 measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Liver steatosis Day 0 measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
blood pressure month 3 measure of blood pressure using sphygmomanometer
Fitness Day 0 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 Month 3 measure of muscle mass using Quantitative ultrasounds (QUS)
fat mass Month 3 measure of muscle mass using Quantitative ultrasounds (QUS)
depression Month 3 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 Month 3 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 Month 3 general health is assessed by the short form 36 health survey (SF36) composed by 36 items
bone structure Month 3 measure of muscle mass using Quantitative ultrasounds (QUS)
Stress Month 3 stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Fatigue Month 3 Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Sleep Month 3 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 Month 3 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 Month 3 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 Month 3 Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Emotions Month 3 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 Month 3 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 Month 3 Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Illness perception Month 3 Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Alexithymia Month 3 Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".
Metacognition Month 3 Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Time perception Month 3 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 Month 3 Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Life style Month 3 life style is assessed with a questionnaire on coffee consumption, food intake, etc
cholesterol Month 3 measure by blood analyses to evaluate alloplastic load
triglycerides Month 3 measure by blood analyses to evaluate alloplastic load
DHEAS Month 3 hormone measure by blood analyses to evaluate alloplastic load
Cortisol Month 3 hormone measure by blood analyses to evaluate alloplastic load
BDNF Month 3 proteins measure by blood analyses to evaluate alloplastic load
TNF alpha Month 3 proteins measure by blood analyses to evaluate alloplastic load
Leptin Month 3 measure by blood analyses to evaluate appetite regulation
CRP Month 3 proteins measure by blood analyses to evaluate alloplastic load
adiponectine Month 3 measure by blood analyses to evaluate appetite regulation
PAI1 Month 3 measure by blood analyses to evaluate cardiovascular function
weight Month 3 measure of weight in kilograms
Homeostasis Month 3 measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Osteoresorption Month 3 measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
waist circumference Month 3 measure of waist circumference in centimetres
CCK Day 0 measure by blood analyses to evaluate appetite regulation
Month 3 Day 0 measure by blood analyses to evaluate appetite regulation
Insulin Month 3 measure by blood analyses to evaluate glucid metabolism
Albumin Month 3 measure by blood analyses to evaluate protid metabolism
HbA1c Month 3 measure by blood analyses to evaluate glucid metabolism
transthyretin Month 3 measure by blood analyses to evaluate protid metabolism
Osteoformation Month 3 measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
glucose Month 3 measure by blood analyses to evaluate glucid metabolism
VEGF Month 3 measure by blood analyses to evaluate cardiovascular function
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France