Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Geneva, Sveits, 1205
- University Hospital of Geneva
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Childhood obesity (>97 percentile WHO references)
Exclusion Criteria:
- being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
- familial history of dyslipidemia or essential hypertension;
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
- orthopaedic affection limiting physical activity;
- genetic disorder or another chronic disease;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Styre
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Eksperimentell: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting.
Parents can choose between the 2 types of therapy.
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The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month).
Both therapies include exercise training twice per week (60 minutes each).
Parents, or at at least the mother, must participate to the behavioral treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in Body Mass Index at 6 months
Tidsramme: 6 months
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Body Mass Index (weight/height 2) expressed in Standard Deviation Score
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in total body and abdominal fat at 6 months
Tidsramme: 6 months
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Body fat mass and percentage assessed using DXA
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6 months
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Change from baseline in waist circumference at 6 months
Tidsramme: 6 months
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6 months
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Change from baseline in blood pressure at 6 months
Tidsramme: 6 months
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Resting and ambulatory (24 hours) systolic and diastolic blood pressure
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6 months
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Change from baseline in arterial intima-media thickness at 6 months
Tidsramme: 6 months
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Measure of the arterial intima-media thickness using high-resolution ultrasound
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6 months
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Change from baseline in arterial flow-mediated dilation at 6 months
Tidsramme: 6 months
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Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
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6 months
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Change from baseline in arterial stiffness at 6 months
Tidsramme: 6 months
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Measure of mechanical indices using tonometry of applanation
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6 months
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Change from baseline in cardiorespiratory fitness at 6 months
Tidsramme: 6 months
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6 months
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Change from baseline in physical activity at 6 months
Tidsramme: 6 months
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Physical activity pattern using accelerometer
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6 months
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Change from baseline in biological markers at 6 months
Tidsramme: 6 months
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Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
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6 months
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Change from baseline in quality of life at 6 months
Tidsramme: 6 months
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Quality of life assessed using the Kidsscreen 52 questionnaire
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6 months
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Change from baseline in child's behavior at 6 months
Tidsramme: 6 months
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Child Behavior Checklist filled by parents
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6 months
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Change from baseline in parental psychological health at 6 months
Tidsramme: 6 months
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Global Health Questionnaire filled by parents
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nathalie Farpour-Lambert, MD, University of Geneva
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SNF 3200B0-120437
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