Trials / Unknown
UnknownNCT01506245
Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- University Hospital, Geneva · Academic / Other
- Sex
- All
- Age
- 8 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2012-06-01
- Completion
- 2012-12-01
- First posted
- 2012-01-09
- Last updated
- 2012-01-09
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01506245. Inclusion in this directory is not an endorsement.