ClinicalTrials.Veeva

Menu

Exercise and Behavioral Therapy in Obese Children

University Hospitals (UH) logo

University Hospitals (UH)

Status

Unknown

Conditions

Childhood Obesity

Treatments

Behavioral: Family-based behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01506245
SNF 3200B0-120437

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Control
No Intervention group
Family-based behavioral therapy
Experimental group
Description:
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Treatment:
Behavioral: Family-based behavioral therapy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems