School Based Health Promotion Program in Secondary Schools

NCT ID: NCT00988754

Last Updated: 2017-10-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

595 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Current understanding of physical activity in childhood demonstrates the health benefits of regular exercise, such as improved cardiovascular fitness, skeletal health and prevention of overweight and obesity. The children obtained weekly health education lessons from their teachers to increase the physical activity in and outside of school and to improve health behavior (healthy food, no drugs) as well as the general well-being of children.

Monthly training for teachers and regular training (2-3x/year) for the parents complete the intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Cardiovascular Risk

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity childhood and adolescence school and family-based lifestyle intervention cardiovascular risk Obesity and associated cardiovascular risk in childhood and adolescence, health behaviour

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type ACTIVE_COMPARATOR

School children and adolescents as health experts

Intervention Type BEHAVIORAL

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

B

Medical examination and information on a healthy lifestyle.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

School children and adolescents as health experts

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Children without written consent from their parents
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bavarian State Ministry of Health and Care

OTHER_GOV

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Halle, Prof., M.D.

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Munich, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18057335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18057339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19506565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19363514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19489963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19264243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19332753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15837955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15477426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19505623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19470602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19434067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19424164 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34666255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30261471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22244041 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21513530 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LP00001 FA 08 07-26

Identifier Type: -

Identifier Source: org_study_id