AzTrials
AzTrials

ObesityJuvenTUM 3NCT00988754

School Based Health Promotion Program in Secondary Schools

A study testing School children and adolescents as health experts in people with Obesity and Cardiovascular Risk, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 9 to 14 years
Conditions the study is for
Obesity, Cardiovascular Risk
What is being tested?
School children and adolescents as health experts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
1 siteGermany
Study dates
Jul 2008to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • Children without written consent from their parents

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Munich, Bavaria, 80992

Other trials in Germany

About this study

Official title: School Children and Adolescents as Health Experts - Step 3

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.

Read the detailed description

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.

Being tested
School children and adolescents as health experts
Keywords
Obesity, childhood and adolescence, school and family-based lifestyle intervention, cardiovascular risk, Obesity and associated cardiovascular risk in childhood and adolescence,, health behaviour
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • School children and adolescents as health expertsBehavioural

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

Study groups in NCT00988754
Study groupRoleWhat they receive
AActive comparatorMedical 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
Receives: Behavioral: School children and adolescents as health experts
BNo interventionMedical examination and information on a healthy lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily physical activity > 60 minutes

    number of days with physical activity > 60 minutes

    Measured: 4 years

Secondary outcomes (7)

  1. Physical fitness

    6-item-test battery (points)

    Measured: 4 years

  2. Anthropometric parameters

    BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg)

    Measured: 4 years

  3. Blood samples

    HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Glucose (mg/dl), Insulin (µU/ml), Leptin (ng/ml), Adiponectin (µg/ml), Il-6 (pg/ml), hsCRP (mg/L)

    Measured: 4 years

  4. Retinal vascular caliber

    Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio

    Measured: 4 years

  5. Lifestyle and socio-economic index

    Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents)

    Measured: 4 years

  6. Arterial stiffness

    Sphygmograph

    Measured: 4 years

  7. Quality of life

    Questionnaire (KINDL-R)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988754
Sponsor's protocol ID
LP00001 FA 08 07-26
Acronym
JuvenTUM 3
Status last verified
Oct 2017
First submitted
1 Oct 2009
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18057335

  • 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.

    PubMed 18057339

  • 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.

    PubMed 19506565

  • 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.

    PubMed 19363514

  • 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.

    PubMed 19489963

  • 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.

    PubMed 19264243

  • 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.

    PubMed 19332753

  • 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.

    PubMed 15837955

  • 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.

    PubMed 15477426

  • 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.

    PubMed 19505623

  • 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.

    PubMed 19470602

  • 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.

    PubMed 19434067

  • 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.

    PubMed 19424164

  • 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.

    PubMed 34666255

  • 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.

    PubMed 30261471

Questions about this trial

What is this clinical trial studying?

A study testing School children and adolescents as health experts in people with Obesity and Cardiovascular Risk, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily physical activity > 60 minutes (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988754, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
JuvenTUM 3 Clinical Trial NCT00988754 | AzTrials