Exercise and Behavioral Therapy in Obese Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Childhood Obesity |
Behavioral: Family-based behavioral therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother |
- Change from baseline in Body Mass Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Body Mass Index (weight/height 2) expressed in Standard Deviation Score
- Change from baseline in total body and abdominal fat at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Body fat mass and percentage assessed using DXA
- Change from baseline in waist circumference at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change from baseline in blood pressure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Resting and ambulatory (24 hours) systolic and diastolic blood pressure
- Change from baseline in arterial intima-media thickness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure of the arterial intima-media thickness using high-resolution ultrasound
- Change from baseline in arterial flow-mediated dilation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
- Change from baseline in arterial stiffness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure of mechanical indices using tonometry of applanation
- Change from baseline in cardiorespiratory fitness at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change from baseline in physical activity at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Physical activity pattern using accelerometer
- Change from baseline in biological markers at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
- Change from baseline in quality of life at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of life assessed using the Kidsscreen 52 questionnaire
- Change from baseline in child's behavior at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Child Behavior Checklist filled by parents
- Change from baseline in parental psychological health at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Global Health Questionnaire filled by parents
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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| Ages Eligible for Study: | 8 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Contacts and Locations| Switzerland | |
| University Hospital of Geneva | |
| Geneva, Switzerland, 1205 | |
| Principal Investigator: | Nathalie Farpour-Lambert, MD | University of Geneva |
More Information
No publications provided
| Responsible Party: | Nathalie Farpour-Lambert, Head of the Obesity Care Program, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT01506245 History of Changes |
| Other Study ID Numbers: | SNF 3200B0-120437 |
| Study First Received: | December 31, 2011 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Geneva:
|
Obesity Children Behavior Family Exercise |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013