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Lifestyle Intervention in Obese Children Attending Special Primary Education.

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ClinicalTrials.gov Identifier: NCT00349232
Recruitment Status : Unknown
Verified July 2006 by University College of Antwerp.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2006
Last Update Posted : July 10, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the prevalence of overweight and obesity in children attending special primary education and to evaluate the effects of a multidisciplinary school-based lifestyle intervention.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: lifestyle intervention (diet and physical activity) Phase 1 Phase 2

Detailed Description:

Lifestyle changes related to high-fat diets and low levels of physical activity have resulted in a rising prevalence of overweight and obesity in children and adolescents. Ten per cent of the world’s school-aged children are estimated to have excess body fat. Overweight and obesity during childhood and adolescence tend to continue into adulthood, increasing the likelihood of a range of impaired health conditions including cardiovascular diseases, diabetes and some cancers. School-based interventions have been proposed to prevent or treat obesity and have been described as a promising approach to reducing obesity among youth. First the extent and the characteristics of the problem have to be assessed for different types of education.

Comparison(s): the prevalence of overweight and obesity in special primary education will be compared to the prevalence in regular primary education. In special primary education, obese and overweight children will be randomised into a experimentel group (6 months of lifestyle intervention including diet and physical activity) and a control group (6 months normal treatment, if any, e.g. exercises for motor skills).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevalence of Overweight and Obesity in Children Attending Special Primary Education and the Effect of a Lifestyle Intervention.
Study Start Date : July 2006
Estimated Study Completion Date : July 2007
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Bodyweight after 3 and 6 months
  2. Bodycomposition after 3 and 6 months
  3. Bodyfat distribution after 3 and 6 months

Secondary Outcome Measures :
  1. Eating behavior after 3 and 6 months
  2. Physical activity after 3 and 6 months
  3. Quality of life after 3 and 6 months

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children attending special and regular primary education

Exclusion Criteria:

  • endocrine conditions affecting bodyweight (e.g. thyroid disease, diabetes)
  • mental or physical disabilities that make it impossible to participate in sports activities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349232


Contacts
Contact: Dirk Vissers 00 32 3 6418265 d.vissers@ha.be

Locations
Belgium
MPI Zonnebos Not yet recruiting
Antwerp, Belgium, 2970
Sponsors and Collaborators
University College of Antwerp
Investigators
Study Chair: Steven Truijen, PhD University College of Antwerp
Principal Investigator: Luc Van Gaal, MD, PhD Universiteit Antwerpen
Study Director: Dirk Vissers University College of Antwerp
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00349232     History of Changes
Other Study ID Numbers: HA-KINE-2006-001
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: July 10, 2006
Last Verified: July 2006

Keywords provided by University College of Antwerp:
childhood obesity
lifestyle intervention
school health program
special primary education

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms