The Svendborg-project (CHAMPS-DK)
2018년 4월 26일 업데이트: University of Southern Denmark
The Childhood Health, Activity, and Motor Performance School Study Denmark
The main aim of this study is to describe differences in development of health and motor performance over time in relation to type of school and other background variables.
연구 개요
연구 유형
중재적
등록 (실제)
1209
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Odense, 덴마크, 5230
- University of Southern Denmark
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
5년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
Trebling of weekly curricular physical education (270 minutes per week)
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Augmented physical education program
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간섭 없음: Control
Standard curriculum physical education (90 minutes per week)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body weight (kilograms)
기간: Change over 2 years
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Standardized assessments performed by trained personal using an electronic scale.
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Change over 2 years
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Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
기간: Change over 2 years
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Standardized assessments performed by trained personal.
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Change over 2 years
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Musculoskeletal problems (injuries, defined as inability to participate in sports)
기간: Total incidence of musculoskeletal problems across 2.5 years
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Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.
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Total incidence of musculoskeletal problems across 2.5 years
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Height (centimeters)
기간: Change over 2 years
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Standardized assessments performed by trained personal using a stadiometer.
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Change over 2 years
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Body-mass index (kg/m^2)
기간: Change over 2 years
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Calculated from measured height and weight
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Change over 2 years
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Waist circumference (centimeters)
기간: Change over 2 years
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Standardized assessments performed by trained personal at the level of the umbilical cord
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Change over 2 years
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DXA determined body fat (%)
기간: Change over 2 years
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In subcohort only.
Standardized assessments performed by trained personal.
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Change over 2 years
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Serum fasting insulin (IU/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting glucose (mmol/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting triglycerides (mmol/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting total cholesterol (mmol/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting low-density lipoprotein cholesterol (mmol/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting high-density lipoprotein cholesterol (mmol/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Serum fasting C-reactive protein (mg/l)
기간: Change over 2 years
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Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
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Change over 2 years
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Homeostasis model assessment of insulin resistance (HOMA-IR)
기간: Change over 2 years
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Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
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Change over 2 years
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Resting systolic blood pressure (mmHg)
기간: Change over 2 years
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Standardized assessments performed by trained personal
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Change over 2 years
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Resting diastolic blood pressure (mmHg)
기간: Change over 2 years
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Standardized assessments performed by trained personal
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Change over 2 years
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Composite risk factor score (z-scores)
기간: Change over 2 years
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Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
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Change over 2 years
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Cardiorespiratory fitness (meters)
기간: Change over 2 years
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Performance on indirect cardiorespiratory fitness test (Andersen-test).
Standardized assessments performed by trained personal
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Change over 2 years
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Handgrip strength (kg)
기간: Change over 2.5 years
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Maximal strength measured by a dynamometer.
Standardized assessments performed by trained personal
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Change over 2.5 years
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Agility (seconds)
기간: Change over 2.5 years
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Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
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Change over 2.5 years
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Backward balance (0-72 points)
기간: Change over 2.5 years
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From the "Korperkoordinations Test fur Kinder".
Standardized assessments performed by trained personal
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Change over 2.5 years
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Maximal vertical jump performance (centimeters)
기간: Change over 2.5 years
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Standardized assessments performed by trained personal
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Change over 2.5 years
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Precision throw (0-30 points)
기간: Change over 2.5 years
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From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
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Change over 2.5 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.
기간: Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
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Physical activity outcomes include; mean count/min, light-physical activity, moderate-physical activity, vigorous-physical activity.
First physical activity assessment made during year 1 of the intervention
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Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Niels Wedderkopp, Prof, University of Southern Denmark
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Moller NC, Leboeuf-Yde C. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK). BMC Pediatr. 2012 Aug 20;12:128. doi: 10.1186/1471-2431-12-128.
- Cheron C, Leboeuf-Yde C, Le Scanff C, Jespersen E, Rexen CT, Franz C, Wedderkopp N. Leisure-time sport and overuse injuries of extremities in children age 6-13, a 2.5 years prospective cohort study: the CHAMPS-study DK. BMJ Open. 2017 Jan 13;7(1):e012606. doi: 10.1136/bmjopen-2016-012606.
- Huang T, Gejl AK, Tarp J, Andersen LB, Peijs L, Bugge A. Cross-sectional associations of objectively measured physical activity with brain-derived neurotrophic factor in adolescents. Physiol Behav. 2017 Mar 15;171:87-91. doi: 10.1016/j.physbeh.2016.12.026. Epub 2016 Dec 24.
- Hebert JJ, Moller NC, Andersen LB, Wedderkopp N. Organized Sport Participation Is Associated with Higher Levels of Overall Health-Related Physical Activity in Children (CHAMPS Study-DK). PLoS One. 2015 Aug 11;10(8):e0134621. doi: 10.1371/journal.pone.0134621. eCollection 2015.
- Heidemann M, Holst R, Schou AJ, Klakk H, Husby S, Wedderkopp N, Molgaard C. The influence of anthropometry and body composition on children's bone health: the childhood health, activity and motor performance school (the CHAMPS) study, Denmark. Calcif Tissue Int. 2015 Feb;96(2):97-104. doi: 10.1007/s00223-014-9941-9. Epub 2014 Dec 25.
- Larsen LR, Kristensen PL, Junge T, Rexen CT, Wedderkopp N. Motor Performance as Predictor of Physical Activity in Children: The CHAMPS Study-DK. Med Sci Sports Exerc. 2015 Sep;47(9):1849-56. doi: 10.1249/MSS.0000000000000604.
- Klakk H, Grontved A, Moller NC, Heidemann M, Andersen LB, Wedderkopp N. Prospective association of adiposity and cardiorespiratory fitness with cardiovascular risk factors in healthy children. Scand J Med Sci Sports. 2014 Aug;24(4):e275-82. doi: 10.1111/sms.12163. Epub 2014 Jan 8.
- Moller NC, Tarp J, Kamelarczyk EF, Brond JC, Klakk H, Wedderkopp N. Do extra compulsory physical education lessons mean more physically active children--findings from the childhood health, activity, and motor performance school study Denmark (The CHAMPS-study DK). Int J Behav Nutr Phys Act. 2014 Sep 24;11:121. doi: 10.1186/s12966-014-0121-0.
- Heidemann M, Jespersen E, Holst R, Schou AJ, Husby S, Molgaard C, Wedderkopp N. The impact on children's bone health of a school-based physical education program and participation in leisure time sports: the Childhood Health, Activity and Motor Performance School (the CHAMPS) study, Denmark. Prev Med. 2013 Aug;57(2):87-91. doi: 10.1016/j.ypmed.2013.04.015. Epub 2013 Apr 30.
- Klakk H, Chinapaw M, Heidemann M, Andersen LB, Wedderkopp N. Effect of four additional physical education lessons on body composition in children aged 8-13 years--a prospective study during two school years. BMC Pediatr. 2013 Oct 17;13:170. doi: 10.1186/1471-2431-13-170.
- Klakk H, Andersen LB, Heidemann M, Moller NC, Wedderkopp N. Six physical education lessons a week can reduce cardiovascular risk in school children aged 6-13 years: a longitudinal study. Scand J Public Health. 2014 Mar;42(2):128-36. doi: 10.1177/1403494813505726. Epub 2013 Sep 20.
- Jespersen E, Rexen CT, Franz C, Moller NC, Froberg K, Wedderkopp N. Musculoskeletal extremity injuries in a cohort of schoolchildren aged 6-12: a 2.5-year prospective study. Scand J Med Sci Sports. 2015 Apr;25(2):251-8. doi: 10.1111/sms.12177. Epub 2014 Jan 29.
- Tarp J, Jespersen E, Moller NC, Klakk H, Wessner B, Wedderkopp N, Bugge A. Long-term follow-up on biological risk factors, adiposity, and cardiorespiratory fitness development in a physical education intervention: a natural experiment (CHAMPS-study DK). BMC Public Health. 2018 May 9;18(1):605. doi: 10.1186/s12889-018-5524-4.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2008년 8월 1일
기본 완료 (실제)
2015년 6월 1일
연구 완료 (실제)
2015년 6월 1일
연구 등록 날짜
최초 제출
2018년 4월 12일
QC 기준을 충족하는 최초 제출
2018년 4월 26일
처음 게시됨 (실제)
2018년 4월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 26일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data are available upon request from the CHAMPS Study Steering Committee due to legal and ethical restrictions.
Interested parties may contact Dr Niels Wedderkopp (nwedderkopp@health.sdu.dk), and the following information will be required at the time of application: a description of how the data will be used, securely managed, and permanently deleted.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .