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NCT Number: NCT07811115

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

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.

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Key information

Conditions

Obese Adolescents Behavior Body Weight Health Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Sedentary Behavior Signs and Symptoms Treatment Adherence and Compliance

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Saint Pierre

Palavas-les-Flots, 34250, France

Location status: Recruiting

Location contact

Delphine Masson

CONTACT

[email protected]

+33467077500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Carotid Intima Media Thickness

    Time frame: During the single assessment visit

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

Secondary outcomes

  1. Anthropometry

    Time frame: At 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.

  2. Tanner Stage

    Time frame: At 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).

  3. Physical activity and sedentary behaviors

    Time frame: Before incusion (single assessment visit)

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

  4. Aerobic fitness

    Time frame: At 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

  5. Maximal Heart Rate

    Time frame: During the aerobic fitness test

    Measured by a heart rate monitor (Polar Pacer 5A)

  6. Perceived Exertion

    Time frame: During the aerobic fitness test

    Assessed by 1 to 10 Borg's scale

  7. Extra media Thickness

    Time frame: At the inclusion (single assessment visit)

    Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm

  8. Arterial diameter

    Time frame: At 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).

  9. Diastolic and systolic blood pressure, pulse pressure

    Time frame: At the inclusion (single assessment visit)

    Measured two times at rest on the left arm by an automated system Omron

  10. Carotid arterial compliance

    Time frame: At inclusion (single assessment visit), calculated from measurements obtained during this visit

    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.

  11. TFEQ-21 questionnaire

    Time frame: at 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.

  12. CAPAS-Q questionnaire

    Time frame: At 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Agnès Vinet

CONTACT

[email protected]

+33 4 13 95 13 44

Sponsors and collaborators

Lead sponsor

University of Avignon

Other

Collaborators

  • Institut Saint Pierre

Registry information

Acronym: CARADO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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