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 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Université d'Auvergne

    collaborator OTHER
  • LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France

    collaborator UNKNOWN
  • LaPEC laboratory (EA 4278), University of Avignon, Avignon, France

    collaborator UNKNOWN
  • Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France

    collaborator UNKNOWN
  • Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France

    collaborator UNKNOWN
  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Frédéric Dutheil · University Hospital, Clermont-Ferrand

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310371 on ClinicalTrials.gov