Clinical trial NCT00349232: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Overweight
Obesity
Keywords: childhood obesity
lifestyle intervention
school health program
special primary education
Lead sponsor: University College of Antwerp
Sponsor class: OTHER
First posted: 2006-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Bodyweight after 3 and 6 months
measure: Bodycomposition after 3 and 6 months
measure: Bodyfat distribution after 3 and 6 months
Secondary outcomes:
measure: Eating behavior after 3 and 6 months
measure: Physical activity after 3 and 6 months
measure: Quality of life after 3 and 6 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: MPI Zonnebos
Study officials:
affiliation: University College of Antwerp
name: Steven Truijen, PhD
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Luc Van Gaal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College of Antwerp
name: Dirk Vissers
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.