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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014