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

2026年9月2日 更新者: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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

108

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Palavas-les-Flots、法国、34250

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Carotid Intima Media Thickness
大体时间:During the single assessment visit
Measured by echography (Mylab, Esaote, Italy) and off-line analyses by CardioVascularSuite, measure in mm
During the single assessment visit

次要结果测量

结果测量
措施说明
大体时间
Anthropometry
大体时间:At the inclusion (single assessment visit )
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
大体时间:At the inclusion (single assessment visit)
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
大体时间:Before incusion (single assessment visit)
Measured by accelerometric data using AX3 Axivity over 7-day consecutive period before inclusion
Before incusion (single assessment visit)
Aerobic fitness
大体时间:At inclusion (the single assessment visit)
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
大体时间:During the aerobic fitness test
Measured by a heart rate monitor (Polar Pacer 5A)
During the aerobic fitness test
Perceived Exertion
大体时间:During the aerobic fitness test
Assessed by 1 to 10 Borg's scale
During the aerobic fitness test
Extra media Thickness
大体时间:At the inclusion (single assessment visit)
Measured by echocardiography (Mylab, Esaote, Italie) and off-line analyses by CAROLAB, in mm
At the inclusion (single assessment visit)
Arterial diameter
大体时间:At the inclusion (single assessment visit)
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
大体时间:At the inclusion (single assessment visit)
Measured two times at rest on the left arm by an automated system Omron
At the inclusion (single assessment visit)
Carotid arterial compliance
大体时间:At inclusion (single assessment visit), calculated from measurements obtained during this visit
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
大体时间:at the inclusion (single assessment visit)
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
大体时间:At the inclusion (single assessment visit)
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月9日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年9月2日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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