Associations Between Physical Activity and Sedentary Behavior Profiles and Carotid Intima-media Thickness in Adolescents With Obesity (CARADO)
2026년 9월 2일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
관찰
등록 (추정된)
108
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Agnès Vinet
- 전화번호: +33 4 13 95 13 44
- 이메일: agnes.vinet@univ-avignon.fr
연구 장소
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Palavas-les-Flots, 프랑스, 34250
- 모병
- Institut Saint Pierre
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연락하다:
- Delphine Masson
- 전화번호: +33467077500
- 이메일: GAY.C@institut-st-pierre.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
확률 샘플
연구 인구
Adolescents were recruited from the specialized pediatric obesity center (COPS) at the Institut Saint-Pierre (Palavas les Flots, 34)
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Carotid Intima Media Thickness
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anthropometry
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 9월 9일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
2026년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AU_ISP1_2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .