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

NCT04310371 | Unknown

• 2 other identifiers: RBHP 2019 DUTHEIL2019-A01804-53
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Adolescent Obesity

Keywords

left myocardial regional function; cardiac ectopic fat deposits; lifestyle programm; prevention; Adolescent Obesity

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (140)

• macrovascularisation

  Day 0

• macrovascularisation

  Month 3

• microvascularisation

  Month 3

• microvascularisation

  Day 0

• microvascularisation

  Day 0

Study Arms (2)

Obese adolescents

EXPERIMENTAL

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

Behavioral: 3-month lifestyle intervention

Control group

NO INTERVENTION

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

Interventions

3-month lifestyle intervention BEHAVIORAL

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.

Obese adolescents

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Université d'Auvergne: collaborator
• LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France: collaborator
• LaPEC laboratory (EA 4278), University of Avignon, Avignon, France: collaborator
• Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France: collaborator
• Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric Dutheil

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants receive an intervention throughout the protocol

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 17, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-02

Locations

FR (1)