Lifestyle Intervention in Obese Children Attending Special Primary Education.

July 6, 2006 updated by: University College of Antwerp

Prevalence of Overweight and Obesity in Children Attending Special Primary Education and the Effect of a Lifestyle Intervention.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Antwerp, Belgium, 2970
        • MPI Zonnebos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bodyweight after 3 and 6 months
Bodycomposition after 3 and 6 months
Bodyfat distribution after 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Eating behavior after 3 and 6 months
Physical activity after 3 and 6 months
Quality of life after 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion

July 1, 2007

Study Registration Dates

First Submitted

July 4, 2006

First Submitted That Met QC Criteria

July 4, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2006

Last Update Submitted That Met QC Criteria

July 6, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA-KINE-2006-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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