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Obese AdolescentsCARADONCT07811115

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

An observational study of Obese Adolescents, run by University of Avignon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 18 years
Conditions the study is for
Obese Adolescents
How many people
108 participants
Where
1 siteFrance
Study dates
9 Sep 2024to Sep 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Agnès Vinet contact

+33 4 13 95 13 44

agnes.vinet@univ-avignon.fr

France1 site, 1 recruiting

  • Institut Saint Pierre

    Palavas-les-Flots, 34250

    Delphine Masson, +33467077500, GAY.C@institut-st-pierre.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Keywords
intima media thickness, physical activity, sedentary, obesity, profiles, compliance, carotid, ultrasound imaging, accelerometer
Medical subject headings
Motor Activity, Sedentary Behavior, Obesity, Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Carotid Intima Media Thickness

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

    Measured: During the single assessment visit

Secondary outcomes (12)

  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.

    Measured: 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).

    Measured: 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

    Measured: 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

    Measured: At inclusion (the single assessment visit)

  5. Maximal Heart Rate

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

    Measured: During the aerobic fitness test

  6. Perceived Exertion

    Assessed by 1 to 10 Borg's scale

    Measured: During the aerobic fitness test

  7. Extra media Thickness

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

    Measured: At the inclusion (single assessment visit)

  8. Arterial diameter

    Measured by ultrasound imaging (Mylab, Esaote, Italie) and off-line analyses by Cardiovascular Suite. Measurements were expressed in millimeters (mm).

    Measured: At the inclusion (single assessment visit)

  9. Diastolic and systolic blood pressure, pulse pressure

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

    Measured: At the inclusion (single assessment visit)

  10. 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.

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

  11. 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.

    Measured: at the inclusion (single assessment visit)

  12. 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)

    Measured: At the inclusion (single assessment visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start9 Sep 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
108 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811115
Sponsor's protocol ID
AU_ISP1_2026
Acronym
CARADO
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Phillips LR, Parfitt G, Rowlands AV. Calibration of the GENEA accelerometer for assessment of physical activity intensity in children. J Sci Med Sport. 2013 Mar;16(2):124-8. doi: 10.1016/j.jsams.2012.05.013. Epub 2012 Jul 6.

    PubMed 22770768

  • Fillon A, Pereira B, Vanhelst J, Baran J, Masurier J, Guirado T, Boirie Y, Duclos M, Julian V, Thivel D. Development of the Children and Adolescents Physical Activity and Sedentary Questionnaire (CAPAS-Q): Psychometric Validity and Clinical Interpretation. Int J Environ Res Public Health. 2022 Oct 23;19(21):13782. doi: 10.3390/ijerph192113782.

    PubMed 36360664

  • Fillon A, Miguet M, O'Malley G, Mathieu ME, Masurier J, Julian V, Cardenoux C, Pereira B, Rey O, Duclos M, Boirie Y, Thivel D. Is the SPARTACUS 15-15 test an accurate proxy for the assessment and tracking of maximal aerobic capacities in adolescents with obesity? J Phys Ther Sci. 2020 Apr;32(4):281-287. doi: 10.1589/jpts.32.281. Epub 2020 Apr 2.

    PubMed 32273651

  • Rolland-Cachera MF, Cole TJ, Sempe M, Tichet J, Rossignol C, Charraud A. Body Mass Index variations: centiles from birth to 87 years. Eur J Clin Nutr. 1991 Jan;45(1):13-21.

    PubMed 1855495

  • Willeit P, Tschiderer L, Allara E, Reuber K, Seekircher L, Gao L, Liao X, Lonn E, Gerstein HC, Yusuf S, Brouwers FP, Asselbergs FW, van Gilst W, Anderssen SA, Grobbee DE, Kastelein JJP, Visseren FLJ, Ntaios G, Hatzitolios AI, Savopoulos C, Nieuwkerk PT, Stroes E, Walters M, Higgins P, Dawson J, Gresele P, Guglielmini G, Migliacci R, Ezhov M, Safarova M, Balakhonova T, Sato E, Amaha M, Nakamura T, Kapellas K, Jamieson LM, Skilton M, Blumenthal JA, Hinderliter A, Sherwood A, Smith PJ, van Agtmael MA, Reiss P, van Vonderen MGA, Kiechl S, Klingenschmid G, Sitzer M, Stehouwer CDA, Uthoff H, Zou ZY, Cunha AR, Neves MF, Witham MD, Park HW, Lee MS, Bae JH, Bernal E, Wachtell K, Kjeldsen SE, Olsen MH, Preiss D, Sattar N, Beishuizen E, Huisman MV, Espeland MA, Schmidt C, Agewall S, Ok E, Asci G, de Groot E, Grooteman MPC, Blankestijn PJ, Bots ML, Sweeting MJ, Thompson SG, Lorenz MW; PROG-IMT and the Proof-ATHERO Study Groups. Carotid Intima-Media Thickness Progression as Surrogate Marker for Cardiovascular Risk: Meta-Analysis of 119 Clinical Trials Involving 100 667 Patients. Circulation. 2020 Aug 18;142(7):621-642. doi: 10.1161/CIRCULATIONAHA.120.046361. Epub 2020 Jun 17.

    PubMed 32546049

Questions about this trial

What is this clinical trial studying?

An observational study of Obese Adolescents, run by University of Avignon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agnès Vinet (+33 4 13 95 13 44, agnes.vinet@univ-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carotid Intima Media Thickness (time frame: During the single assessment visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07811115, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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