Lifestyle Intervention in Obese Children Attending Special Primary Education.

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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. Review.

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.

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. Review.

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. Review.

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. Review.

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.

Müller MJ, Danielzik S, Pust S. School- and family-based interventions to prevent overweight in children. Proc Nutr Soc. 2005 May;64(2):249-54. Review.

ClinicalTrials.gov Identifier:	NCT00349232 History of Changes
Other Study ID Numbers:	HA-KINE-2006-001
First Posted:	July 6, 2006
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