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.
調査の概要
状態
募集
条件
研究の種類
観察的
入学 (推定)
108
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Agnès Vinet
- 電話番号：+33 4 13 95 13 44
- メール：agnes.vinet@univ-avignon.fr
研究場所
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Palavas-les-Flots、フランス、34250
- 募集
- Institut Saint Pierre
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コンタクト：
- Delphine Masson
- 電話番号：+33467077500
- メール：GAY.C@institut-st-pierre.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Carotid Intima Media Thickness
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anthropometry
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年9月9日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年9月2日
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AU_ISP1_2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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