Exercise and Behavioral Therapy in Obese Children
Primary Purpose
Childhood Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Family-based behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Obesity, Children, Behavior, Family, Exercise
Eligibility 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;
Sites / Locations
- University Hospital of Geneva
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Family-based behavioral therapy
Arm Description
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Outcomes
Primary Outcome Measures
Change from baseline in Body Mass Index at 6 months
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
Body fat mass and percentage assessed using DXA
Change from baseline in waist circumference at 6 months
Change from baseline in blood pressure at 6 months
Resting and ambulatory (24 hours) systolic and diastolic blood pressure
Change from baseline in arterial intima-media thickness at 6 months
Measure of the arterial intima-media thickness using high-resolution ultrasound
Change from baseline in arterial flow-mediated dilation at 6 months
Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
Change from baseline in arterial stiffness at 6 months
Measure of mechanical indices using tonometry of applanation
Change from baseline in cardiorespiratory fitness at 6 months
Change from baseline in physical activity at 6 months
Physical activity pattern using accelerometer
Change from baseline in biological markers at 6 months
Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
Change from baseline in quality of life at 6 months
Quality of life assessed using the Kidsscreen 52 questionnaire
Change from baseline in child's behavior at 6 months
Child Behavior Checklist filled by parents
Change from baseline in parental psychological health at 6 months
Global Health Questionnaire filled by parents
Full Information
NCT ID
NCT01506245
First Posted
December 31, 2011
Last Updated
January 4, 2012
Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01506245
Brief Title
Exercise and Behavioral Therapy in Obese Children
Official Title
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Children, Behavior, Family, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Family-based behavioral therapy
Arm Type
Experimental
Arm Description
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Intervention Type
Behavioral
Intervention Name(s)
Family-based behavioral therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Body Mass Index at 6 months
Description
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in total body and abdominal fat at 6 months
Description
Body fat mass and percentage assessed using DXA
Time Frame
6 months
Title
Change from baseline in waist circumference at 6 months
Time Frame
6 months
Title
Change from baseline in blood pressure at 6 months
Description
Resting and ambulatory (24 hours) systolic and diastolic blood pressure
Time Frame
6 months
Title
Change from baseline in arterial intima-media thickness at 6 months
Description
Measure of the arterial intima-media thickness using high-resolution ultrasound
Time Frame
6 months
Title
Change from baseline in arterial flow-mediated dilation at 6 months
Description
Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
Time Frame
6 months
Title
Change from baseline in arterial stiffness at 6 months
Description
Measure of mechanical indices using tonometry of applanation
Time Frame
6 months
Title
Change from baseline in cardiorespiratory fitness at 6 months
Time Frame
6 months
Title
Change from baseline in physical activity at 6 months
Description
Physical activity pattern using accelerometer
Time Frame
6 months
Title
Change from baseline in biological markers at 6 months
Description
Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
Time Frame
6 months
Title
Change from baseline in quality of life at 6 months
Description
Quality of life assessed using the Kidsscreen 52 questionnaire
Time Frame
6 months
Title
Change from baseline in child's behavior at 6 months
Description
Child Behavior Checklist filled by parents
Time Frame
6 months
Title
Change from baseline in parental psychological health at 6 months
Description
Global Health Questionnaire filled by parents
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Farpour-Lambert, MD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
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Exercise and Behavioral Therapy in Obese Children
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