NCT00349232

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 10, 2006

Status Verified

July 1, 2006

First QC Date

July 4, 2006

Last Update Submit

July 6, 2006

Conditions

OverweightObesity

Keywords

childhood obesitylifestyle interventionschool health programspecial primary education

Outcome Measures

Primary Outcomes (3)

  • Bodyweight after 3 and 6 months

  • Bodycomposition after 3 and 6 months

  • Bodyfat distribution after 3 and 6 months

Secondary Outcomes (3)

  • Eating behavior after 3 and 6 months

  • Physical activity after 3 and 6 months

  • Quality of life after 3 and 6 months

Interventions

lifestyle intervention (diet and physical activity)BEHAVIORAL

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children attending special and regular primary education

You may not qualify if:

  • endocrine conditions affecting bodyweight (e.g. thyroid disease, diabetes)
  • mental or physical disabilities that make it impossible to participate in sports activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MPI Zonnebos

Antwerp, Antwerp, 2970, Belgium

Location

Related Publications (7)

  • 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.

    PMID: 15096099BACKGROUND

  • 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.

    PMID: 11319638BACKGROUND

  • 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.

    PMID: 10340798BACKGROUND

  • 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.

    PMID: 11157310BACKGROUND

  • 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.

    PMID: 9130034BACKGROUND

  • 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.

    PMID: 10201726BACKGROUND

  • 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.

    PMID: 15960869BACKGROUND

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven Truijen, PhD

    University College of Antwerp

    STUDY CHAIR

  • Luc Van Gaal, MD, PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Dirk Vissers

    University College of Antwerp

    STUDY DIRECTOR

Central Study Contacts

Dirk Vissers

CONTACT

00 32 3 6418265d.vissers@ha.be

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 4, 2006

First Posted

July 6, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2007

Last Updated

July 10, 2006

Record last verified: 2006-07

Locations

BE(1)