Associations Between Physical Activity and Sedentary Behavior Profiles and Carotid Intima-media Thickness in Adolescents With Obesity (CARADO)
2 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Observacional
Inscrição (Estimado)
108
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Agnès Vinet
- Número de telefone: +33 4 13 95 13 44
- E-mail: agnes.vinet@univ-avignon.fr
Locais de estudo
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Palavas-les-Flots, França, 34250
- Recrutamento
- Institut Saint Pierre
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Contato:
- Delphine Masson
- Número de telefone: +33467077500
- E-mail: GAY.C@institut-st-pierre.fr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra de Probabilidade
População do estudo
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Carotid Intima Media Thickness
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Anthropometry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de setembro de 2024
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Aceitação dos Cuidados de Saúde pelo Paciente
- Obesidade
- Atividade motora
- Comportamento Sedentário
- Conformidade do paciente
Outros números de identificação do estudo
- AU_ISP1_2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .