The Svendborg-project (CHAMPS-DK)
2018年4月26日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
1209
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Odense、デンマーク、5230
- University of Southern Denmark
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
5年～11年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Exclusion Criteria:
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention
Trebling of weekly curricular physical education (270 minutes per week)
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Augmented physical education program
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介入なし：Control
Standard curriculum physical education (90 minutes per week)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body weight (kilograms)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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)
時間枠：Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
|
Serum fasting triglycerides (mmol/l)
時間枠：Change over 2 years
|
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)
時間枠：Change over 2 years
|
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)
時間枠：Change over 2 years
|
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)
時間枠：Change over 2 years
|
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)
時間枠：Change over 2 years
|
Standardized assessments performed by trained biomedical laboratory technicians.
Fasting status affirmed verbally.
|
Change over 2 years
|
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Homeostasis model assessment of insulin resistance (HOMA-IR)
時間枠：Change over 2 years
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Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
|
Change over 2 years
|
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Resting systolic blood pressure (mmHg)
時間枠：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)
時間枠：Change over 2 years
|
Standardized assessments performed by trained personal
|
Change over 2 years
|
|
Composite risk factor score (z-scores)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Change over 2.5 years
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Measured by the 50 meter short-shuttle test.
Standardized assessments performed by trained personal
|
Change over 2.5 years
|
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Backward balance (0-72 points)
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Niels Wedderkopp, Prof、University of Southern Denmark
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2008年8月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2015年6月1日
試験登録日
最初に提出
2018年4月12日
QC基準を満たした最初の提出物
2018年4月26日
最初の投稿 (実際)
2018年4月27日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月27日
QC基準を満たした最後の更新が送信されました
2018年4月26日
最終確認日
2018年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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