ObesityCARDIBOXNCT04310371
Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)
A study testing 3-month lifestyle intervention in people with Obesity and Adolescent Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent Obesity
- What is being tested?
- 3-month lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Dutheil
About this study
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
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.
Read the 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.
- Conditions
- Obesity, Adolescent Obesity
- Being tested
- 3-month lifestyle intervention
- Keywords
- left myocardial regional function, cardiac ectopic fat deposits, lifestyle programm, prevention, Adolescent Obesity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Obese adolescents | Experimental | BMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention Receives: Behavioral: 3-month lifestyle intervention |
| Control group | No intervention | to be normal-weighted (no obesity if overweight, <85th percentile of national curves). |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Measured: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
Measured: Day 0
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
Measured: Day 0
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (volume using MRI)
Measured: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Measured: Month 3
cardiac ectopic fat deposits
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
Measured: Day 0
left myocardial regional function
left myocardial regional function (echocardiography)
Measured: Month 3
left myocardial regional function
left myocardial regional function (MRI)
Measured: Month 3
left myocardial regional function
left myocardial regional function (echocardiography)
Measured: Day 0
left myocardial regional function
left myocardial regional function (MRI)
Measured: Day 0
Secondary outcomes (140)
macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Measured: Day 0
macrovascularisation
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
Measured: Month 3
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Measured: Month 3
microvascularisation
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
Measured: Day 0
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Measured: Day 0
microvascularisation
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
Measured: Month 3
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
Measured: Month 3
microvascularisation
measure of microvascular perfusion using Iontophoresis procedure
Measured: Day 0
microvascularisation
measure of microvascular perfusion using flowmotion
Measured: Day 0
microvascularisation
measure of microvascular perfusion using flowmotion
Measured: Month 3
heart rate variability
measure of heart rate variability using a holter
Measured: Month 3
heart rate variability
measure of heart rate variability using a holter
Measured: Day 0
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
Measured: Day 0
skin conductance
measure of skin conductance using Wristband electrodes - Empatica E4
Measured: Month 3
Liver steatosis
measure of liver steatosis by MRI
Measured: Month 3
Liver steatosis
measure of liver steatosis by MRI
Measured: Day 0
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Measured: Day 0
Liver steatosis
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
Measured: Month 3
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Measured: month 3
Liver steatosis
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
Measured: Day 0
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Measured: Day 0
Liver fibrosis
measure of liver fibrosis by fibroscanner (liver stiffness)
Measured: Month 3
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Measured: Month 3
Liver fibrosis
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
Measured: Day 0
blood pressure
measure of blood pressure using sphygmomanometer
Measured: Day0
blood pressure
measure of blood pressure using sphygmomanometer
Measured: 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.
Measured: 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.
Measured: Day 0
muscle mass
measure of muscle mass using impedancemeter
Measured: Month 3
fat mass
measure of muscle mass using impedancemeter
Measured: Month 3
bone structure
measure of muscle mass using impedancemeter
Measured: Month 3
muscle mass
measure of muscle mass using impedancemeter
Measured: Day 0
fat mass
measure of muscle mass using impedancemeter
Measured: Day 0
bone structure
measure of muscle mass using impedancemeter
Measured: Day 0
muscle mass
measure of muscle mass using Densitometry X-ray absorption
Measured: Day 0
fat mass
measure of muscle mass using Densitometry X-ray absorption
Measured: Day 0
bone structure
measure of muscle mass using Densitometry X-ray absorption
Measured: Day 0
muscle mass
measure of muscle mass using Densitometry X-ray absorption
Measured: Month 3
fat mass
measure of muscle mass using Densitometry X-ray absorption
Measured: Month 3
bone structure
measure of muscle mass using Densitometry X-ray absorption
Measured: Month 3
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Month 3
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Month 3
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Month 3
muscle mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Day 0
fat mass
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Day 0
bone structure
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
Measured: Day 0
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: Day 0
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: Day 0
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: Day 0
muscle mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: Month 3
fat mass
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: Month 3
bone structure
measure of muscle mass using Quantitative ultrasounds (QUS)
Measured: 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".
Measured: 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".
Measured: 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"
Measured: 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"
Measured: Month 3
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Measured: Day 0
General health
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
Measured: Month 3
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Measured: day 0
Stress
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Measured: Month 3
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Measured: Day 0
Fatigue
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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)
Measured: 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)
Measured: Month 3
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Measured: Day 0
Coping
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Month 3
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Measured: Day 0
Self-efficacy
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
Measured: 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".
Measured: 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".
Measured: Month 3
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Measured: Day 0
Illness perception
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
Measured: Month 3
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Measured: Day 0
Metacognition
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
Measured: 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".
Measured: 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".
Measured: Month 3
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Measured: Day 0
Physical activity
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
Measured: Month 3
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Measured: Day 0
Life style
life style is assessed with a questionnaire on coffee consumption, food intake, etc
Measured: Month 3
cholesterol
measure by blood analyses to evaluate alloplastic load
Measured: Day 0
triglycerides
measure by blood analyses to evaluate alloplastic load
Measured: Day 0
cholesterol
measure by blood analyses to evaluate alloplastic load
Measured: Month 3
triglycerides
measure by blood analyses to evaluate alloplastic load
Measured: Month 3
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
Measured: Day 0
Cortisol
hormone measure by blood analyses to evaluate alloplastic load
Measured: Month 3
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
Measured: day 0
DHEAS
hormone measure by blood analyses to evaluate alloplastic load
Measured: Month 3
BDNF
proteins measure by blood analyses to evaluate alloplastic load
Measured: Day 0
BDNF
proteins measure by blood analyses to evaluate alloplastic load
Measured: Month 3
CRP
proteins measure by blood analyses to evaluate alloplastic load
Measured: Day 0
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
Measured: Day 0
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
Measured: Day 0
CRP
proteins measure by blood analyses to evaluate alloplastic load
Measured: Month 3
pro-inflammatory cytokines
proteins measure by blood analyses to evaluate alloplastic load
Measured: Month 3
TNF alpha
proteins measure by blood analyses to evaluate alloplastic load
Measured: Month 3
NPY
proteins measure by blood analyses to evaluate alloplastic load
Measured: Month 3
NPY
proteins measure by blood analyses to evaluate alloplastic load
Measured: Day 0
Leptin
measure by blood analyses to evaluate appetite regulation
Measured: Day 0
Leptin
measure by blood analyses to evaluate appetite regulation
Measured: Month 3
Ghrelin
measure by blood analyses to evaluate appetite regulation
Measured: Day 0
Ghrelin
measure by blood analyses to evaluate appetite regulation
Measured: Month 3
NPY
measure by blood analyses to evaluate appetite regulation
Measured: day 0
NPY
measure by blood analyses to evaluate appetite regulation
Measured: Month 3
adiponectine
measure by blood analyses to evaluate appetite regulation
Measured: Day 0
adiponectine
measure by blood analyses to evaluate appetite regulation
Measured: Month 3
CCK
measure by blood analyses to evaluate appetite regulation
Measured: Day 0
Month 3
measure by blood analyses to evaluate appetite regulation
Measured: Day 0
Insulin
measure by blood analyses to evaluate glucid metabolism
Measured: Day 0
Insulin
measure by blood analyses to evaluate glucid metabolism
Measured: Month 3
HbA1c
measure by blood analyses to evaluate glucid metabolism
Measured: Day 0
HbA1c
measure by blood analyses to evaluate glucid metabolism
Measured: Month 3
glucose
measure by blood analyses to evaluate glucid metabolism
Measured: Day 0
glucose
measure by blood analyses to evaluate glucid metabolism
Measured: Month 3
Albumin
measure by blood analyses to evaluate protid metabolism
Measured: Day 0
Albumin
measure by blood analyses to evaluate protid metabolism
Measured: Month 3
transthyretin
measure by blood analyses to evaluate protid metabolism
Measured: Day 0
transthyretin
measure by blood analyses to evaluate protid metabolism
Measured: Month 3
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Measured: Day 0
Homeostasis
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
Measured: Month 3
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Measured: Day 0
Osteoresorption
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
Measured: Month 3
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Measured: Day 0
Osteoformation
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
Measured: Month 3
VEGF
measure by blood analyses to evaluate cardiovascular function
Measured: Day 0
VEGF
measure by blood analyses to evaluate cardiovascular function
Measured: Month 3
PAI1
measure by blood analyses to evaluate cardiovascular function
Measured: Day 0
PAI1
measure by blood analyses to evaluate cardiovascular function
Measured: Month 3
weight
measure of weight in kilograms
Measured: Day 0
weight
measure of weight in kilograms
Measured: Month 3
waist circumference
measure of waist circumference in centimetres
Measured: Day 0
waist circumference
measure of waist circumference in centimetres
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study startSep 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- participants receive an intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Frédéric Dutheil, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310371
- Sponsor's protocol ID
- RBHP 2019 DUTHEIL
- Other IDs
- 2019-A01804-53
- Acronym
- CARDIBOX
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04310371
- Acronym / sponsor ID
- CARDIBOX / RBHP 2019 DUTHEIL
- Conditions
- Obesity, Adolescent Obesity
- Keywords
- left myocardial regional function, cardiac ectopic fat deposits, lifestyle programm, prevention, Adolescent Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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 start
- Sep 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants receive an intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents | Experimental | Behavioral: 3-month lifestyle interventionBMI greater than the 97th percentile of national curves. Participants will follow a 3-month lifestyle intervention |
| Control group | No intervention | –to be normal-weighted (no obesity if overweight, <85th percentile of national curves). |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- age between 12 and 16 years old
- mature (menarche)
- suitable for physical activity
- able to give an informative consent
- affiliated at French insurance company
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-month lifestyle interventionAdolescents 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. | Behavioural | Obese adolescents |
Primary outcome
cardiac ectopic fat deposits
Time frame: Month 3
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
cardiac ectopic fat deposits
Time frame: Day 0
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
cardiac ectopic fat deposits
Time frame: Day 0
Quantification of cardiac ectopic fat deposits (volume using MRI)
cardiac ectopic fat deposits
Time frame: Month 3
Quantification of cardiac ectopic fat deposits (volume using MRI)
cardiac ectopic fat deposits
Time frame: Month 3
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
cardiac ectopic fat deposits
Time frame: Day 0
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
left myocardial regional function
Time frame: Month 3
left myocardial regional function (echocardiography)
left myocardial regional function
Time frame: Month 3
left myocardial regional function (MRI)
left myocardial regional function
Time frame: Day 0
left myocardial regional function (echocardiography)
left myocardial regional function
Time frame: Day 0
left myocardial regional function (MRI)
140 secondary outcomes
macrovascularisation
Time frame: Day 0
macrovascularisation
Time frame: Month 3
microvascularisation
Time frame: Month 3
microvascularisation
Time frame: Day 0
microvascularisation
Time frame: Day 0
microvascularisation
Time frame: Month 3
microvascularisation
Time frame: Month 3
microvascularisation
Time frame: Day 0
microvascularisation
Time frame: Day 0
microvascularisation
Time frame: Month 3
heart rate variability
Time frame: Month 3
heart rate variability
Time frame: Day 0
skin conductance
Time frame: Day 0
skin conductance
Time frame: Month 3
Liver steatosis
Time frame: Month 3
Liver steatosis
Time frame: Day 0
Liver steatosis
Time frame: Day 0
Liver steatosis
Time frame: Month 3
Liver steatosis
Time frame: month 3
Liver steatosis
Time frame: Day 0
Liver fibrosis
Time frame: Day 0
Liver fibrosis
Time frame: Month 3
Liver fibrosis
Time frame: Month 3
Liver fibrosis
Time frame: Day 0
blood pressure
Time frame: Day0
blood pressure
Time frame: month 3
Fitness
Time frame: Month 3
Fitness
Time frame: Day 0
muscle mass
Time frame: Month 3
fat mass
Time frame: Month 3
bone structure
Time frame: Month 3
muscle mass
Time frame: Day 0
fat mass
Time frame: Day 0
bone structure
Time frame: Day 0
muscle mass
Time frame: Day 0
fat mass
Time frame: Day 0
bone structure
Time frame: Day 0
muscle mass
Time frame: Month 3
fat mass
Time frame: Month 3
bone structure
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Dutheil principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-month lifestyle intervention in people with Obesity and Adolescent Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac ectopic fat deposits (time frame: Month 3). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.