Associations Between Physical Activity and Sedentary Behavior Profiles and Carotid Intima-media Thickness in Adolescents With Obesity (CARADO)
2 settembre 2026 aggiornato da: University of Avignon
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Tipo di studio
Osservativo
Iscrizione (Stimato)
108
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Agnès Vinet
- Numero di telefono: +33 4 13 95 13 44
- Email: agnes.vinet@univ-avignon.fr
Luoghi di studio
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Palavas-les-Flots, Francia, 34250
- Reclutamento
- Institut Saint Pierre
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Contatto:
- Delphine Masson
- Numero di telefono: +33467077500
- Email: GAY.C@institut-st-pierre.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Carotid Intima Media Thickness
Lasso di tempo: During the single assessment visit
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Measured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm
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During the single assessment visit
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Anthropometry
Lasso di tempo: At the inclusion (single assessment visit )
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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.
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At the inclusion (single assessment visit )
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Tanner Stage
Lasso di tempo: At the inclusion (single assessment visit)
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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).
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At the inclusion (single assessment visit)
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Physical activity and sedentary behaviors
Lasso di tempo: Before incusion (single assessment visit)
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Measured by accelerometric data using AX3 Axivity over 7-day consecutive period before inclusion
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Before incusion (single assessment visit)
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Aerobic fitness
Lasso di tempo: At inclusion (the single assessment visit)
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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
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At inclusion (the single assessment visit)
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Maximal Heart Rate
Lasso di tempo: During the aerobic fitness test
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Measured by a heart rate monitor (Polar Pacer 5A)
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During the aerobic fitness test
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Perceived Exertion
Lasso di tempo: During the aerobic fitness test
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Assessed by 1 to 10 Borg's scale
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During the aerobic fitness test
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Extra media Thickness
Lasso di tempo: At the inclusion (single assessment visit)
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Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
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At the inclusion (single assessment visit)
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Arterial diameter
Lasso di tempo: At the inclusion (single assessment visit)
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Measured by ultrasound imaging (Mylab, Esaote, Italie) and off-line analyses by Cardiovascular Suite.
Measurements were expressed in millimeters (mm).
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At the inclusion (single assessment visit)
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Diastolic and systolic blood pressure, pulse pressure
Lasso di tempo: At the inclusion (single assessment visit)
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Measured two times at rest on the left arm by an automated system Omron
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At the inclusion (single assessment visit)
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Carotid arterial compliance
Lasso di tempo: At inclusion (single assessment visit), calculated from measurements obtained during this visit
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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.
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At inclusion (single assessment visit), calculated from measurements obtained during this visit
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TFEQ-21 questionnaire
Lasso di tempo: at the inclusion (single assessment visit)
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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.
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at the inclusion (single assessment visit)
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CAPAS-Q questionnaire
Lasso di tempo: At the inclusion (single assessment visit)
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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)
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At the inclusion (single assessment visit)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
9 settembre 2024
Completamento primario (Stimato)
1 marzo 2027
Completamento dello studio (Stimato)
1 settembre 2027
Date di iscrizione allo studio
Primo inviato
2 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 settembre 2026
Primo Inserito (Effettivo)
9 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi della nutrizione
- Ipernutrizione
- Peso corporeo
- Sovrappeso
- Condizioni patologiche, segni e sintomi
- Comportamento
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Aderenza e conformità al trattamento
- Comportamento sanitario
- Accettazione dell'assistenza sanitaria da parte del paziente
- Obesità
- Attività motoria
- Comportamento sedentario
- Conformità del paziente
Altri numeri di identificazione dello studio
- AU_ISP1_2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .