Lifestyle Intervention in Obese Children Attending Special Primary Education.

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00349232
• Other study ID #: HA-KINE-2006-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 4, 2006
• Last updated: July 6, 2006
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2006
• Source: University College of Antwerp
• Contact: Dirk Vissers
• Phone: 00 32 3 6418265
• Email: d.vissers[@]ha.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• lifestyle intervention (diet and physical activity)

Locations

Country	Name	City	State
Belgium	MPI Zonnebos	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University College of Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View Citation

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bodyweight after 3 and 6 months
Primary	Bodycomposition after 3 and 6 months
Primary	Bodyfat distribution after 3 and 6 months
Secondary	Eating behavior after 3 and 6 months
Secondary	Physical activity after 3 and 6 months
Secondary	Quality of life after 3 and 6 months