- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00988754
School Based Health Promotion Program in Secondary Schools (JuvenTUM 3)
School Children and Adolescents as Health Experts - Step 3
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bavaria
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Munich, Bavaria, 독일, 80992
- Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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
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Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents
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간섭 없음: B
Medical examination and information on a healthy lifestyle.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Daily physical activity > 60 minutes
기간: 4 years
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number of days with physical activity > 60 minutes
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4 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical fitness
기간: 4 years
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6-item-test battery (points)
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4 years
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Anthropometric parameters
기간: 4 years
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BMI (kg/m2), BMI-SDS, Waist and upper arm circumferences (cm), skinfold thickness (mm), Blood pressure (mm Hg)
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4 years
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Blood samples
기간: 4 years
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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)
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4 years
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Retinal vascular caliber
기간: 4 years
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Central retinal arteriolar (CRAE) and venular (CRVE) vessel diameters, arteriolar-to-venular-ratio
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4 years
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Lifestyle and socio-economic index
기간: 4 years
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Questionnaire concerning eating pattern, sitting behavior, smoking, drinking, school level parents, nationality children and parents)
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4 years
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Arterial stiffness
기간: 4 years
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Sphygmograph
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4 years
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Quality of life
기간: 4 years
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Questionnaire (KINDL-R)
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4 years
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공동 작업자 및 조사자
수사관
- 연구 의자: Martin Halle, Prof., M.D., Department of Medicine, Division of Prevention, Rehabilitation and Sports Medicine, Technical University Munich, Germany
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lloyd 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.
- 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.
- 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.
- 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.
- 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.
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .