NCT00988754

Brief Summary

The purpose of the study is to determine whether a school based health promotion program in secondary schools is effective with respect to an increase of physical activity, physical fitness and health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
595

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

October 1, 2009

Last Update Submit

October 12, 2017

Conditions

ObesityCardiovascular Risk

Keywords

Obesitychildhood and adolescenceschool and family-based lifestyle interventioncardiovascular riskObesity and associated cardiovascular risk in childhood and adolescence,health behaviour

Outcome Measures

Primary Outcomes (1)

  • Daily physical activity > 60 minutes

    number of days with physical activity \> 60 minutes

    4 years

Secondary Outcomes (7)

  • Physical fitness

    4 years

  • Anthropometric parameters

    4 years

  • Blood samples

    4 years

  • Retinal vascular caliber

    4 years

  • Lifestyle and socio-economic index

    4 years

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

Medical examination once per year, school and family-based lifestyle intervention including a weekly health lesson, school-affiliation to sports clubs and regularly trainings for teachers and parents

Behavioral: School children and adolescents as health experts

B

NO INTERVENTION

Medical examination and information on a healthy lifestyle.

Interventions

School children and adolescents as health expertsBEHAVIORAL

Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents

A

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children in the 1. grade of secondary General Schools or Intermediate Schools with written consent from the parents in the greater Munich area

You may not qualify if:

  • Children without written consent from their parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich

Munich, Bavaria, 80992, Germany

Location

Related Publications (17)

  • Baker JL, Olsen LW, Sorensen TI. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med. 2007 Dec 6;357(23):2329-37. doi: 10.1056/NEJMoa072515.

    PMID: 18057335BACKGROUND

  • Bibbins-Domingo K, Coxson P, Pletcher MJ, Lightwood J, Goldman L. Adolescent overweight and future adult coronary heart disease. N Engl J Med. 2007 Dec 6;357(23):2371-9. doi: 10.1056/NEJMsa073166.

    PMID: 18057339BACKGROUND

  • Owen CG, Whincup PH, Orfei L, Chou QA, Rudnicka AR, Wathern AK, Kaye SJ, Eriksson JG, Osmond C, Cook DG. Is body mass index before middle age related to coronary heart disease risk in later life? Evidence from observational studies. Int J Obes (Lond). 2009 Aug;33(8):866-77. doi: 10.1038/ijo.2009.102. Epub 2009 Jun 9.

    PMID: 19506565BACKGROUND

  • Birch LL, Ventura AK. Preventing childhood obesity: what works? Int J Obes (Lond). 2009 Apr;33 Suppl 1:S74-81. doi: 10.1038/ijo.2009.22.

    PMID: 19363514BACKGROUND

  • Saarelainen H, Valtonen P, Punnonen K, Laitinen T, Raitakari OT, Juonala M, Heiskanen N, Lyyra-Laitinen T, Viikari JS, Heinonen S. Flow mediated vasodilation and circulating concentrations of high sensitive C-reactive protein, interleukin-6 and tumor necrosis factor-alpha in normal pregnancy--The Cardiovascular Risk in Young Finns Study. Clin Physiol Funct Imaging. 2009 Sep;29(5):347-52. doi: 10.1111/j.1475-097X.2009.00877.x. Epub 2009 Jun 1.

    PMID: 19489963BACKGROUND

  • Magnussen CG, Venn A, Thomson R, Juonala M, Srinivasan SR, Viikari JS, Berenson GS, Dwyer T, Raitakari OT. The association of pediatric low- and high-density lipoprotein cholesterol dyslipidemia classifications and change in dyslipidemia status with carotid intima-media thickness in adulthood evidence from the cardiovascular risk in Young Finns study, the Bogalusa Heart study, and the CDAH (Childhood Determinants of Adult Health) study. J Am Coll Cardiol. 2009 Mar 10;53(10):860-9. doi: 10.1016/j.jacc.2008.09.061.

    PMID: 19264243BACKGROUND

  • Harris KC, Kuramoto LK, Schulzer M, Retallack JE. Effect of school-based physical activity interventions on body mass index in children: a meta-analysis. CMAJ. 2009 Mar 31;180(7):719-26. doi: 10.1503/cmaj.080966.

    PMID: 19332753BACKGROUND

  • Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.

    PMID: 15837955BACKGROUND

  • Hayman LL, Williams CL, Daniels SR, Steinberger J, Paridon S, Dennison BA, McCrindle BW; Committee on Atherosclerosis, Hypertension, and Obesity in Youth (AHOY) of the Council on Cardiovascular Disease in the Young, American Heart Association. Cardiovascular health promotion in the schools: a statement for health and education professionals and child health advocates from the Committee on Atherosclerosis, Hypertension, and Obesity in Youth (AHOY) of the Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 2004 Oct 12;110(15):2266-75. doi: 10.1161/01.CIR.0000141117.85384.64. No abstract available.

    PMID: 15477426BACKGROUND

  • McCall A, Raj R. Exercise for prevention of obesity and diabetes in children and adolescents. Clin Sports Med. 2009 Jul;28(3):393-421. doi: 10.1016/j.csm.2009.03.001.

    PMID: 19505623BACKGROUND

  • Oetzel KB, Scott AA, McGrath J. School-based health centers and obesity prevention: changing practice through quality improvement. Pediatrics. 2009 Jun;123 Suppl 5:S267-71. doi: 10.1542/peds.2008-2780D.

    PMID: 19470602BACKGROUND

  • Dunford LJ, Langley-Evans SC, McMullen S. Childhood obesity and adult cardiovascular disease risk: a systematic review. Int J Obes (Lond). 2010 Jan;34(1):18-28. doi: 10.1038/ijo.2009.61. Epub 2009 May 12.

    PMID: 19434067BACKGROUND

  • Bruss MB, Michael TJ, Morris JR, Applegate B, Dannison L, Quitugua JA, Palacios RT, Klein DJ. Childhood obesity prevention: an intervention targeting primary caregivers of school children. Obesity (Silver Spring). 2010 Jan;18(1):99-107. doi: 10.1038/oby.2009.111. Epub 2009 May 7.

    PMID: 19424164BACKGROUND

  • Siegrist M, Heitkamp M, Braun I, Vogg N, Haller B, Langhof H, Koenig W, Halle M. Changes of omentin-1 and chemerin during 4 weeks of lifestyle intervention and 1 year follow-up in children with obesity. Clin Nutr. 2021 Nov;40(11):5648-5654. doi: 10.1016/j.clnu.2021.09.042. Epub 2021 Oct 8.

    PMID: 34666255DERIVED

  • Siegrist M, Hanssen H, Lammel C, Haller B, Koch AM, Stemp P, Dandl E, Liestak R, Parhofer KG, Vogeser M, Halle M. Effects of a cluster-randomized school-based prevention program on physical activity and microvascular function (JuvenTUM 3). Atherosclerosis. 2018 Nov;278:73-81. doi: 10.1016/j.atherosclerosis.2018.09.003. Epub 2018 Sep 8.

    PMID: 30261471DERIVED

  • Hanssen H, Siegrist M, Neidig M, Renner A, Birzele P, Siclovan A, Blume K, Lammel C, Haller B, Schmidt-Trucksass A, Halle M. Retinal vessel diameter, obesity and metabolic risk factors in school children (JuvenTUM 3). Atherosclerosis. 2012 Mar;221(1):242-8. doi: 10.1016/j.atherosclerosis.2011.12.029. Epub 2011 Dec 27.

    PMID: 22244041DERIVED

  • Siegrist M, Hanssen H, Lammel C, Haller B, Halle M. A cluster randomised school-based lifestyle intervention programme for the prevention of childhood obesity and related early cardiovascular disease (JuvenTUM 3). BMC Public Health. 2011 Apr 22;11:258. doi: 10.1186/1471-2458-11-258.

    PMID: 21513530DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martin Halle, Prof., M.D.

    Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

DE(1)