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Exercise and Behavioral Therapy in Obese Children

4. januar 2012 opdateret af: Nathalie Farpour-Lambert, University Hospital, Geneva

Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother

The aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Geneva, Schweiz, 1205
        • University Hospital of Geneva

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Eksperimentel: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Adfærdsmæssigt: Family-based behavioral therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Body Mass Index at 6 months
Tidsramme: 6 months
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in total body and abdominal fat at 6 months
Tidsramme: 6 months
Body fat mass and percentage assessed using DXA
6 months
Change from baseline in waist circumference at 6 months
Tidsramme: 6 months
6 months
Change from baseline in blood pressure at 6 months
Tidsramme: 6 months
Resting and ambulatory (24 hours) systolic and diastolic blood pressure
6 months
Change from baseline in arterial intima-media thickness at 6 months
Tidsramme: 6 months
Measure of the arterial intima-media thickness using high-resolution ultrasound
6 months
Change from baseline in arterial flow-mediated dilation at 6 months
Tidsramme: 6 months
Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
6 months
Change from baseline in arterial stiffness at 6 months
Tidsramme: 6 months
Measure of mechanical indices using tonometry of applanation
6 months
Change from baseline in cardiorespiratory fitness at 6 months
Tidsramme: 6 months
6 months
Change from baseline in physical activity at 6 months
Tidsramme: 6 months
Physical activity pattern using accelerometer
6 months
Change from baseline in biological markers at 6 months
Tidsramme: 6 months
Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
6 months
Change from baseline in quality of life at 6 months
Tidsramme: 6 months
Quality of life assessed using the Kidsscreen 52 questionnaire
6 months
Change from baseline in child's behavior at 6 months
Tidsramme: 6 months
Child Behavior Checklist filled by parents
6 months
Change from baseline in parental psychological health at 6 months
Tidsramme: 6 months
Global Health Questionnaire filled by parents
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Geneva

Samarbejdspartnere

Swiss National Science Foundation

Efterforskere

  • Ledende efterforsker: Nathalie Farpour-Lambert, MD, University of Geneva

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Forventet)

1. juni 2012

Studieafslutning (Forventet)

1. december 2012

Datoer for studieregistrering

Først indsendt

31. december 2011

Først indsendt, der opfyldte QC-kriterier

4. januar 2012

Først opslået (Skøn)

9. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SNF 3200B0-120437

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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