Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

2 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

108

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Carotid Intima Media Thickness
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Avignon

Medewerkers

Institut Saint Pierre

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 september 2024

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

2 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

9 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AU_ISP1_2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren