Associations Between Physical Activity and Sedentary Behavior Profiles and Carotid Intima-media Thickness in Adolescents With Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-18
SponsorUniversity of Avignon

About this trial

Physical activity behaviors are key and modifiable factors of cardiovascular health from childhood. They encompass both physical activity, defined as any bodily movement produced by skeletal muscles that results in energy expenditure, and sedentary behavior, characterized by low energy expenditure while awake. Studying these behaviors in their diversity, beyond a simple active-inactive opposition, allows for a better understanding of their effects on health.

In adolescents, high levels of sedentary behavior and low levels of physical activity are both associated with an increased risk of overweight or obesity. Current recommendations advocate for at least 60 minutes of moderate-to-vigorous physical activity per day and the reduction of sedentary time. However, more than 80% of French adolescents do not meet these recommendations, a trend that is even more pronounced and problematic among those living with obesity.

Pediatric obesity is associated with early alterations in vascular health. Carotid intima-media thickness (cIMT), measured by ultrasound, is a recognized biomarker of future cardiovascular risk. Several studies have shown that sustained physical activity is associated with lower cIMT and better endothelial function, independently of body size. However, the methodological limitations of current studies, and the lack of data specific to adolescents with obesity, highlight the need for further research.

This project aims to better understand, in adolescents with obesity, the associations between physical activity and sedentary behavior profiles and physical fitness, on the one hand, and structural parameters, particularly cIMT, and vascular functional parameters known for their value as subclinical biomarkers of cardiovascular risk, on the other hand.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The parent(s) or legal guardian(s) must have provided parental consent, and the adolescent must have provided their assent.

The adolescent must be affiliated with or covered by a health insurance scheme.

The adolescent must be aged between 11 and 18 years.

The participant must have a Body Mass Index (BMI) Z-score corresponding to obesity (reference: Rolland-Cachera et al., 1991 growth charts).

Disqualifiers

The adolescent has a contraindication to physical activity (joint, cardiac, or other).

The adolescent is participating in another study.

The adolescent is within an exclusion period determined by a previous study.

The parent(s) or legal guardian(s) or the adolescent refuses to sign the parental consent or assent form, respectively.

Trial population

Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Carotid Intima Media Thickness

Measured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm

Time frame
During the single assessment visit

Secondary outcomes

1

Anthropometry

Height (cm), body mass (kg) used to calcultate the body mass index (BMI in kg/m² and z-score) as body mass/height\*height. Body composition is assessed using bioelectrical impedance analysis (BIA) mBCA SECA. Fat mass, fat-free and muscle mass are measured in kg, reported to the body mass in %. Waist and neck circumference measured by a tape measure.

Time frame
At the inclusion (single assessment visit )
2

Tanner Stage

A clinical assessment performed by a medical doctor to determine the stage of pubertal development based on the development of secondary sexual characteristics. Pubertal development is classified into five stages, ranging from stage I (prepubertal) to stage V (full maturation).

Time frame
At the inclusion (single assessment visit)
3

Physical activity and sedentary behaviors

Measured by accelerometric data using AX3 Axivity over 7-day consecutive period before inclusion

Time frame
Before incusion (single assessment visit)
4

Aerobic fitness

Measured by the Spartacus 15-15 test, a progressive intermittent maximal running field test with prediction of VO2 max (Fillon et al., 2020) For girls: VO2max = last stage \* 153.4433 + BMI \* 58.64534 + age \* -2.701522-921.2878 For boys: VO2max = last stage \* 153.4433 + 320.1583 + BMI \* 58.64534 + age \* -2.701522-921.2878

Time frame
At inclusion (the single assessment visit)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Avignon

Lead sponsor

Institut Saint Pierre

Collaborator