Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT03510494
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Svendborg-project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D001265', 'term': 'Athletic Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention group receiving 270 minutes of weekly physical education Control group receiving 90 minutes of weekly physical education Intervention group physical education teachers receiving physical education courses (ATK-concept)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity determined objectively using waist-worn accelerometry. Participants will be asked to wear the monitors for at least one week.', 'timeFrame': 'Non-specific follow-up duration as multiple time-points are considered (follow-up at 2, 3.5 and 6.5 years)', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Body weight (kilograms)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal using an electronic scale.'}, {'measure': 'Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal.'}, {'measure': 'Musculoskeletal problems (injuries, defined as inability to participate in sports)', 'timeFrame': 'Total incidence of musculoskeletal problems across 2.5 years', 'description': 'Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.'}, {'measure': 'Height (centimeters)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal using a stadiometer.'}, {'measure': 'Body-mass index (kg/m^2)', 'timeFrame': 'Change over 2 years', 'description': 'Calculated from measured height and weight'}, {'measure': 'Waist circumference (centimeters)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal at the level of the umbilical cord'}, {'measure': 'DXA determined body fat (%)', 'timeFrame': 'Change over 2 years', 'description': 'In subcohort only. Standardized assessments performed by trained personal.'}, {'measure': 'Serum fasting insulin (IU/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting glucose (mmol/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting triglycerides (mmol/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting total cholesterol (mmol/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting low-density lipoprotein cholesterol (mmol/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting high-density lipoprotein cholesterol (mmol/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Serum fasting C-reactive protein (mg/l)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.'}, {'measure': 'Homeostasis model assessment of insulin resistance (HOMA-IR)', 'timeFrame': 'Change over 2 years', 'description': 'Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5'}, {'measure': 'Resting systolic blood pressure (mmHg)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal'}, {'measure': 'Resting diastolic blood pressure (mmHg)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized assessments performed by trained personal'}, {'measure': 'Composite risk factor score (z-scores)', 'timeFrame': 'Change over 2 years', 'description': 'Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness'}, {'measure': 'Cardiorespiratory fitness (meters)', 'timeFrame': 'Change over 2 years', 'description': 'Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal'}, {'measure': 'Handgrip strength (kg)', 'timeFrame': 'Change over 2.5 years', 'description': 'Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal'}, {'measure': 'Agility (seconds)', 'timeFrame': 'Change over 2.5 years', 'description': 'Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal'}, {'measure': 'Backward balance (0-72 points)', 'timeFrame': 'Change over 2.5 years', 'description': 'From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal'}, {'measure': 'Maximal vertical jump performance (centimeters)', 'timeFrame': 'Change over 2.5 years', 'description': 'Standardized assessments performed by trained personal'}, {'measure': 'Precision throw (0-30 points)', 'timeFrame': 'Change over 2.5 years', 'description': "From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood', 'Risk Factor, Cardiovascular', 'Sports Injury', 'Physical Activity', 'Motor Activity']}, 'referencesModule': {'references': [{'pmid': '22906115', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28087543', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28027935', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26262678', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25539855', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '25539477', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24397591', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25248973', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23643934', 'type': 'RESULT', 'citation': "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."}, {'pmid': '24131778', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24055828', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24472003', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '41182572', 'type': 'DERIVED', 'citation': 'Wedderkopp N, Wang C, Steele R, Hebert J, Rexen C, Jespersen E, Junge T, Thomsen T, Jensen FM, Shrier I. Incidence of and Risk Factors for Lower Extremity Apophysitis in Children and Adolescents. Sports Med. 2025 Nov 3. doi: 10.1007/s40279-025-02328-w. Online ahead of print.'}, {'pmid': '29739385', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled at school participating in study\n* Grade 0 - 4\n* written, informed consent provided by parent or legal guardian\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT03510494', 'acronym': 'CHAMPS-DK', 'briefTitle': 'The Svendborg-project', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'The Childhood Health, Activity, and Motor Performance School Study Denmark', 'orgStudyIdInfo': {'id': 'S-20080047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Trebling of weekly curricular physical education (270 minutes per week)', 'interventionNames': ['Behavioral: Augmented physical education program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard curriculum physical education (90 minutes per week)'}], 'interventions': [{'name': 'Augmented physical education program', 'type': 'BEHAVIORAL', 'description': 'Augmented physical education program', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Niels Wedderkopp, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Lillebælt', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}