Exercise and Behavioral Therapy in Obese Children

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Family-based behavioral therapy

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospital of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Body Mass Index at 6 months	Body Mass Index (weight/height 2) expressed in Standard Deviation Score	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total body and abdominal fat at 6 months	Body fat mass and percentage assessed using DXA	6 months
Change from baseline in waist circumference at 6 months		6 months
Change from baseline in blood pressure at 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	Measure of the arterial intima-media thickness using high-resolution ultrasound	6 months
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	6 months
Change from baseline in arterial stiffness at 6 months	Measure of mechanical indices using tonometry of applanation	6 months
Change from baseline in cardiorespiratory fitness at 6 months		6 months
Change from baseline in physical activity at 6 months	Physical activity pattern using accelerometer	6 months
Change from baseline in biological markers at 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	Quality of life assessed using the Kidsscreen 52 questionnaire	6 months
Change from baseline in child's behavior at 6 months	Child Behavior Checklist filled by parents	6 months
Change from baseline in parental psychological health at 6 months	Global Health Questionnaire filled by parents	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Nathalie Farpour-Lambert, MD, University of Geneva

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 31, 2011
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 9, 2012

Study Record Updates

• Last Update Posted (Estimate): January 9, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Family; Obesity; Children; Behavior
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: SNF 3200B0-120437