Lifestyle Intervention in Obese Children Attending Special Primary Education.
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
lifestyle intervention (diet and physical activity)
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring childhood obesity, lifestyle intervention, school health program, special primary education
Eligibility 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
Sites / Locations
- MPI Zonnebos
Outcomes
Primary Outcome Measures
Bodyweight after 3 and 6 months
Bodycomposition after 3 and 6 months
Bodyfat distribution after 3 and 6 months
Secondary Outcome Measures
Eating behavior after 3 and 6 months
Physical activity after 3 and 6 months
Quality of life after 3 and 6 months
Full Information
NCT ID
NCT00349232
First Posted
July 4, 2006
Last Updated
July 6, 2006
Sponsor
University College of Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00349232
Brief Title
Lifestyle Intervention in Obese Children Attending Special Primary Education.
Official Title
Prevalence of Overweight and Obesity in Children Attending Special Primary Education and the Effect of a Lifestyle Intervention.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University College of Antwerp
4. Oversight
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
childhood obesity, lifestyle intervention, school health program, special primary education
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention (diet and physical activity)
Primary Outcome Measure Information:
Title
Bodyweight after 3 and 6 months
Title
Bodycomposition after 3 and 6 months
Title
Bodyfat distribution after 3 and 6 months
Secondary Outcome Measure Information:
Title
Eating behavior after 3 and 6 months
Title
Physical activity after 3 and 6 months
Title
Quality of life after 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Vissers
Phone
00 32 3 6418265
Email
d.vissers@ha.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Truijen, PhD
Organizational Affiliation
University College of Antwerp
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luc Van Gaal, MD, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Vissers
Organizational Affiliation
University College of Antwerp
Official's Role
Study Director
Facility Information:
Facility Name
MPI Zonnebos
City
Antwerp
ZIP/Postal Code
2970
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
15096099
Citation
Lobstein T, Baur L, Uauy R; IASO International Obesity TaskForce. Obesity in children and young people: a crisis in public health. Obes Rev. 2004 May;5 Suppl 1:4-104. doi: 10.1111/j.1467-789X.2004.00133.x. No abstract available.
Results Reference
background
PubMed Identifier
11319638
Citation
Hulens M, Beunen G, Claessens AL, Lefevre J, Thomis M, Philippaerts R, Borms J, Vrijens J, Lysens R, Vansant G. Trends in BMI among Belgian children, adolescents and adults from 1969 to 1996. Int J Obes Relat Metab Disord. 2001 Mar;25(3):395-9. doi: 10.1038/sj.ijo.0801513.
Results Reference
background
PubMed Identifier
10340798
Citation
Must A, Strauss RS. Risks and consequences of childhood and adolescent obesity. Int J Obes Relat Metab Disord. 1999 Mar;23 Suppl 2:S2-11. doi: 10.1038/sj.ijo.0800852.
Results Reference
background
PubMed Identifier
11157310
Citation
Goran MI. Metabolic precursors and effects of obesity in children: a decade of progress, 1990-1999. Am J Clin Nutr. 2001 Feb;73(2):158-71. doi: 10.1093/ajcn/73.2.158.
Results Reference
background
PubMed Identifier
9130034
Citation
Van Gaal LF, Wauters MA, De Leeuw IH. The beneficial effects of modest weight loss on cardiovascular risk factors. Int J Obes Relat Metab Disord. 1997 Mar;21 Suppl 1:S5-9.
Results Reference
background
PubMed Identifier
10201726
Citation
Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixit S, Fox MK, Laird N. Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health. Arch Pediatr Adolesc Med. 1999 Apr;153(4):409-18. doi: 10.1001/archpedi.153.4.409.
Results Reference
background
PubMed Identifier
15960869
Citation
Muller MJ, Danielzik S, Pust S. School- and family-based interventions to prevent overweight in children. Proc Nutr Soc. 2005 May;64(2):249-54. doi: 10.1079/pns2005424.
Results Reference
background
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Lifestyle Intervention in Obese Children Attending Special Primary Education.
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