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Lifestyle Intervention in Obese Children Attending Special Primary Education.

NCT ID: NCT00349232

Last Updated: 2006-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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).

Conditions

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Overweight Obesity

Keywords

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childhood obesity lifestyle intervention school health program special primary education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lifestyle intervention (diet and physical activity)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College of Antwerp

OTHER

Sponsor Role lead

Principal Investigators

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Steven Truijen, PhD

Role: STUDY_CHAIR

University College of Antwerp

Luc Van Gaal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Dirk Vissers

Role: STUDY_DIRECTOR

University College of Antwerp

Locations

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MPI Zonnebos

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Central Contacts

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Dirk Vissers

Role: CONTACT

Phone: 00 32 3 6418265

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 15096099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11319638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10340798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11157310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9130034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10201726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15960869 (View on PubMed)

Other Identifiers

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HA-KINE-2006-001

Identifier Type: -

Identifier Source: org_study_id