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CARADO
Sponsor study identifier
observational
108
1 country
1
Study Start
September 9, 2024
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2024
Actual (reported)September 2, 2026
Actual (reported)September 9, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Carotid Intima Media Thickness
Measured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm
During the single assessment visit
Anthropometry
At the inclusion (single assessment visit )
Tanner Stage
At the inclusion (single assessment visit)
Physical activity and sedentary behaviors
Before incusion (single assessment visit)
Aerobic fitness
At inclusion (the single assessment visit)
Maximal Heart Rate
During the aerobic fitness test
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
Institut Saint Pierre
Palavas-les-Flots, 34250, France
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, 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.
First Submitted
September 2, 2026
First Posted
September 9, 2026
Study Start
September 9, 2024
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
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 Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 9, 2026
Record last verified: 2026-09
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