Exercise and Behavioral Therapy in Obese Children

Not Applicable

• Conditions: Childhood Obesity
• Interventions: Behavioral: Family-based behavioral therapy

• Registration Number: NCT01506245
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-12-31
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-04
• Last Update Submitted: 2012-01-04
• Study First Posted: 2012-01-09
• Last Update Posted: 2012-01-09
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-based behavioral therapy	Family-based behavioral therapy	Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Body Mass Index at 6 months	6 months	Body Mass Index (weight/height 2) expressed in Standard Deviation Score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland