Clinical trial NCT01506245: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: Obesity
Children
Behavior
Family
Exercise
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2012-01-09
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Change from baseline in Body Mass Index at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in total body and abdominal fat at 6 months
timeFrame: 6 months
measure: Change from baseline in waist circumference at 6 months
timeFrame: 6 months
measure: Change from baseline in blood pressure at 6 months
timeFrame: 6 months
measure: Change from baseline in arterial intima-media thickness at 6 months
timeFrame: 6 months
measure: Change from baseline in arterial flow-mediated dilation at 6 months
timeFrame: 6 months
measure: Change from baseline in arterial stiffness at 6 months
timeFrame: 6 months
measure: Change from baseline in cardiorespiratory fitness at 6 months
timeFrame: 6 months
measure: Change from baseline in physical activity at 6 months
timeFrame: 6 months
measure: Change from baseline in biological markers at 6 months
timeFrame: 6 months
measure: Change from baseline in quality of life at 6 months
timeFrame: 6 months
measure: Change from baseline in child's behavior at 6 months
timeFrame: 6 months
measure: Change from baseline in parental psychological health at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: University of Geneva
name: Nathalie Farpour-Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References: