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

2 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

108

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Carotid Intima Media Thickness
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anthropometry
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: During the aerobic fitness test
Measured by a heart rate monitor (Polar Pacer 5A)
During the aerobic fitness test
Perceived Exertion
Tidsram: During the aerobic fitness test
Assessed by 1 to 10 Borg's scale
During the aerobic fitness test
Extra media Thickness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Avignon

Samarbetspartners

Institut Saint Pierre

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 september 2024

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 september 2027

Studieregistreringsdatum

Först inskickad

2 september 2026

Först inskickad som uppfyllde QC-kriterierna

2 september 2026

Första postat (Faktisk)

9 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AU_ISP1_2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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