An observational study in Obese Adolescents, sponsored by University of Avignon. Recruiting at 1 site in France. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Avignon · Observational
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 108 is below the median of 158 across 176 observational studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Avignon is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 )
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)
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)
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)
Maximal Heart Rate
Measured by a heart rate monitor (Polar Pacer 5A)
Time frame: During the aerobic fitness test
Perceived Exertion
Assessed by 1 to 10 Borg's scale
Time frame: During the aerobic fitness test
Extra media Thickness
Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
Time frame: At the inclusion (single assessment visit)
Arterial diameter
Measured by ultrasound imaging (Mylab, Esaote, Italie) and off-line analyses by Cardiovascular Suite. Measurements were expressed in millimeters (mm).
Time frame: At the inclusion (single assessment visit)
Diastolic and systolic blood pressure, pulse pressure
Measured two times at rest on the left arm by an automated system Omron
Time frame: At the inclusion (single assessment visit)
Carotid arterial compliance
Assessed by ultrasound using carotid artery diameter and blood pressure measurements. Compliance is calculated from the change in arterial diameter in response to pulse pressure.
Time frame: At inclusion (single assessment visit), calculated from measurements obtained during this visit
TFEQ-21 questionnaire
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.
Time frame: at the inclusion (single assessment visit)
CAPAS-Q questionnaire
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)
Time frame: At the inclusion (single assessment visit)
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Mar 2027, 30 months after the start.
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