Exercise and Behavioral Therapy in Obese Children

Childhood Obesity Clinical Trial

Official title:

Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01506245
• Other study ID #: SNF 3200B0-120437
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 31, 2011
• Last updated: January 4, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Body Mass Index at 6 months	Body Mass Index (weight/height 2) expressed in Standard Deviation Score	6 months	No
Secondary	Change from baseline in total body and abdominal fat at 6 months	Body fat mass and percentage assessed using DXA	6 months	No
Secondary	Change from baseline in waist circumference at 6 months		6 months	No
Secondary	Change from baseline in blood pressure at 6 months	Resting and ambulatory (24 hours) systolic and diastolic blood pressure	6 months	No
Secondary	Change from baseline in arterial intima-media thickness at 6 months	Measure of the arterial intima-media thickness using high-resolution ultrasound	6 months	No
Secondary	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	No
Secondary	Change from baseline in arterial stiffness at 6 months	Measure of mechanical indices using tonometry of applanation	6 months	No
Secondary	Change from baseline in cardiorespiratory fitness at 6 months		6 months	No
Secondary	Change from baseline in physical activity at 6 months	Physical activity pattern using accelerometer	6 months	No
Secondary	Change from baseline in biological markers at 6 months	Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.	6 months	No
Secondary	Change from baseline in quality of life at 6 months	Quality of life assessed using the Kidsscreen 52 questionnaire	6 months	No
Secondary	Change from baseline in child's behavior at 6 months	Child Behavior Checklist filled by parents	6 months	No
Secondary	Change from baseline in parental psychological health at 6 months	Global Health Questionnaire filled by parents	6 months	No