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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07811115
Acronym
CARADO
Enrollment
108
Registered
2026-09-09
Start date
2024-09-09
Completion date
2027-09-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Adolescents

Keywords

intima media thickness, physical activity, sedentary, obesity, profiles, compliance, carotid, ultrasound imaging, accelerometer

Brief summary

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.

Interventions

None listed

Sponsors

University of Avignon
Lead SponsorOTHER
Institut Saint Pierre
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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. * It is not possible to provide the adolescent or the parent(s) or legal guardian(s) with the required information for informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Carotid Intima Media ThicknessDuring the single assessment visitMeasured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm

Secondary

MeasureTime frameDescription
AnthropometryAt the inclusion (single assessment visit )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.
Tanner StageAt the inclusion (single assessment visit)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).
Physical activity and sedentary behaviorsBefore incusion (single assessment visit)Measured by accelerometric data using AX3 Axivity over 7-day consecutive period before inclusion
Aerobic fitnessAt inclusion (the single assessment visit)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
Maximal Heart RateDuring the aerobic fitness testMeasured by a heart rate monitor (Polar Pacer 5A)
Perceived ExertionDuring the aerobic fitness testAssessed by 1 to 10 Borg's scale
Extra media ThicknessAt the inclusion (single assessment visit)Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
Arterial diameterAt the inclusion (single assessment visit)Measured by ultrasound imaging (Mylab, Esaote, Italie) and off-line analyses by Cardiovascular Suite. Measurements were expressed in millimeters (mm).
Diastolic and systolic blood pressure, pulse pressureAt the inclusion (single assessment visit)Measured two times at rest on the left arm by an automated system Omron
Carotid arterial complianceAt inclusion (single assessment visit), calculated from measurements obtained during this visitAssessed by ultrasound using carotid artery diameter and blood pressure measurements. Compliance is calculated from the change in arterial diameter in response to pulse pressure.
TFEQ-21 questionnaireat the inclusion (single assessment visit)Three-Factor Eating Questionnaire. A 21-item self-report questionnaire used to assess three dimensions of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. Each dimension is scored separately, with higher scores indicating a greater tendency toward the corresponding eating behavior.
CAPAS-Q questionnaireAt the inclusion (single assessment visit)Children and Adolescents Physical Activity en Sedentary Questionnaire. A self-administered questionnaire designed to assess physical activity and sedentary behaviors in children and adolescents. It evaluates the frequency and duration of physical activities performed at different intensities, as well as sedentary behaviors, providing an assessment of the participant's usual physical activity and sedentary behavior patterns (Fillon et al., 2022)

Countries

France

Contacts

CONTACTAgnès Vinet
agnes.vinet@univ-avignon.fr+33 4 13 95 13 44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026