Lifestyle Intervention in Obese Children Attending Special Primary Education.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overweight Obesity | Behavioral: lifestyle intervention (diet and physical activity) | Phase 1 Phase 2 |
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 (Clinical Trial) |
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 |
Study Completion Date : | July 2007 |
- Bodyweight after 3 and 6 months
- Bodycomposition after 3 and 6 months
- Bodyfat distribution after 3 and 6 months
- Eating behavior after 3 and 6 months
- Physical activity after 3 and 6 months
- Quality of life after 3 and 6 months

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Dirk Vissers | 00 32 3 6418265 | d.vissers@ha.be |
Belgium | |
MPI Zonnebos | Not yet recruiting |
Antwerp, Belgium, 2970 |
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:
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 |