Exercise and Behavioral Therapy in Obese Children

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Nathalie Farpour-Lambert, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01506245
First received: December 31, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Family-based behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Change from baseline in Body Mass Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body Mass Index (weight/height 2) expressed in Standard Deviation Score


Secondary Outcome Measures:
  • Change from baseline in total body and abdominal fat at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body fat mass and percentage assessed using DXA

  • Change from baseline in waist circumference at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Resting and ambulatory (24 hours) systolic and diastolic blood pressure

  • Change from baseline in arterial intima-media thickness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure of the arterial intima-media thickness using high-resolution ultrasound

  • Change from baseline in arterial flow-mediated dilation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound

  • Change from baseline in arterial stiffness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure of mechanical indices using tonometry of applanation

  • Change from baseline in cardiorespiratory fitness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in physical activity at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Physical activity pattern using accelerometer

  • Change from baseline in biological markers at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.

  • Change from baseline in quality of life at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life assessed using the Kidsscreen 52 questionnaire

  • Change from baseline in child's behavior at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Child Behavior Checklist filled by parents

  • Change from baseline in parental psychological health at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Global Health Questionnaire filled by parents


Estimated Enrollment: 75
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Behavioral: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506245

Locations
Switzerland
University Hospital of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Investigators
Principal Investigator: Nathalie Farpour-Lambert, MD University of Geneva
  More Information

No publications provided

Responsible Party: Nathalie Farpour-Lambert, Head of the Obesity Care Program, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01506245     History of Changes
Other Study ID Numbers: SNF 3200B0-120437
Study First Received: December 31, 2011
Last Updated: January 4, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Obesity
Children
Behavior
Family
Exercise

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014