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

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.

Study Overview

• Status: Recruiting
• Conditions: Obese Adolescents

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Agnès Vinet; Phone Number: +33 4 13 95 13 44; Email: agnes.vinet@univ-avignon.fr

Study Locations

• France
  • Palavas-les-Flots, France, 34250
    • Recruiting
    • Institut Saint Pierre
    • Contact: Delphine Masson; Phone Number: +33467077500; Email: GAY.C@institut-st-pierre.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid Intima Media Thickness	Measured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm	During the single assessment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	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	At inclusion (the single assessment visit)
Maximal Heart Rate	Measured by a heart rate monitor (Polar Pacer 5A)	During the aerobic fitness test
Perceived Exertion	Assessed by 1 to 10 Borg's scale	During the aerobic fitness test
Extra media Thickness	Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm	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).	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	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.	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.	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)	At the inclusion (single assessment visit)

Collaborators and Investigators

• Sponsor: University of Avignon
• Collaborators: Institut Saint Pierre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; obesity; compliance; ultrasound imaging; sedentary; accelerometer; carotid; intima media thickness; profiles
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Obesity; Motor Activity; Sedentary Behavior; Patient Compliance
• Other Study ID Numbers: AU_ISP1_2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No