Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 1:45 PM
Study NCT ID:
NCT01295203
Status:
COMPLETED
Last Update Posted:
2011-02-14
First Post:
2011-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Physical Activity Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-11', 'studyFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self reported physical activity', 'timeFrame': 'after 3 month', 'description': 'Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)'}, {'measure': 'Self reported physical activity', 'timeFrame': 'After 6 month', 'description': 'Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'after 3 month', 'description': 'Body weight was measured to the nearest 0.1 kg and percent point with a Segmeantal Body Composition Analyser (type BC-418 MA, Tanita Corp., Tokyo, Japan).'}, {'measure': 'Fat percentage', 'timeFrame': 'after 3 month', 'description': 'Fat percentage was measured to the nearest 0.1 kg and percent point with a Segmeantal Body Composition Analyser (type BC-418 MA, Tanita Corp., Tokyo, Japan).'}, {'measure': 'Hip and Waist circumference', 'timeFrame': 'after 3 month', 'description': 'Hip and waist circumference was measured with a body tape (Chasmors WM02 Body Tape, Chasmors Ltd.,London, United Kingdom) to the nearest 1.0 cm. Waist circumference was measured midway between the iliac crest and the costal margin following a quiet expiration, and lastly hip circumference was measured at the maximal circumference over the buttocks and below the iliac crest.'}, {'measure': 'blood pressure', 'timeFrame': '3 month', 'description': 'Systolic and diastolic blood pressure were measured by fully automatic clinically validated blood pressure monitors (UA 779, UA-767 Plus 30 or UA 767 PC, A\\&D Company Ltd, Tokyo, Japan)'}, {'measure': 'Aerobic fitness', 'timeFrame': 'after 3 month', 'description': 'Estimated during a max (watt-max) or a sub-maximal test on a ergometer bike depending on the physical condition of the participant (Ergomedic 828E, Monark Exercise AB, Vansbro, Sweden). One of the following conditions contraindicated participation in the watt-max test: Any heart-related disease, chest pain, hypertension (\\>160/100 mmHg), heart or lung (pulmonary) medication, pregnancy and muscle, joint or skeletal problems. The sub-max test was contradicted by hypertension (\\>180/110 mmHg), severe heart-related disease, certain types of heart medication, muscle, joint or skeletal problems.'}, {'measure': 'Arm muscle strength', 'timeFrame': 'after 3 month', 'description': 'Arm mucle strength was measured by bending of the arms with a Takei TKK 5402 digital back strength dynamometer (Takei Scientific Instruments Co. Ltd., Tokyo, Japan). The test was performed with maximal exertion.'}, {'measure': 'blood samples', 'timeFrame': 'After 3 months', 'description': 'Non-fasting venous blood samples were collected for future analyses of P-cholesterol, P-triglyceride, and haemoglobin A1c and for biobank storage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '23111127', 'type': 'DERIVED', 'citation': 'Hansen AW, Gronbaek M, Helge JW, Severin M, Curtis T, Tolstrup JS. Effect of a Web-based intervention to promote physical activity and improve health among physically inactive adults: a population-based randomized controlled trial. J Med Internet Res. 2012 Oct 30;14(5):e145. doi: 10.2196/jmir.2109.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements', 'detailedDescription': 'In a website-based intervention study, the investigators wish to examine if it is possible to increase physical activity among inactive persons. Main objective is to determine if access to a website with personalized feedback on PA level and suggestions to increase PA results in improvements in self reported PA, anthropometrics and applied physiological measurements.\n\nPhysical inactive adults (n=12,287) participating in a nationwide health survey and examination (DANHES) were asked to randomly assigned to either intervention (n=6,055) or control group (n=6,232). The intervention group had access to a PA website with personalized advice and suggestions to increase PA. After 3 and 6 months, a follow-up questionnaire was administered by e-mail. The 7-day International Physical Activity Questionnaire was included in the questionnaires to assess four domains of PA in daily-life (work, transportation, domestic, and leisure-time) and sedentary time. Furthermore, at the 3 month follow-up a subgroup of participants (n=1,190) were invited complete anthropometrics and physiological measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Physically inactive in leisure time (assessed by self reported questionnaire)\n\nExclusion Criteria:\n\n* Presence of serious heart problems or not being able to perform everyday activities\n* Highly physically active in leisure time (assessed by self reported questionnaire)'}, 'identificationModule': {'nctId': 'NCT01295203', 'briefTitle': 'Internet-based Physical Activity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Internet-based Physical Activity Intervention', 'orgStudyIdInfo': {'id': 'NIPH 1957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group were not given access to the intervention website and received no additional information.', 'interventionNames': ['Behavioral: website assess']}], 'interventions': [{'name': 'website assess', 'type': 'BEHAVIORAL', 'description': 'The internet intervention group were given assess to the intervention website which included a personal page with tailored physical activity advice and a personal profile together with Recommendations and general training programs.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1353', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National Institute of Public Health', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Municipality of Frederiksberg', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Municipality of Silkeborg', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}, {'zip': '6800', 'city': 'Varde', 'country': 'Denmark', 'facility': 'Municipality of Varde', 'geoPoint': {'lat': 55.62112, 'lon': 8.48069}}], 'overallOfficials': [{'name': 'Andreas Wolff Hansen, Msc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Andreas Wolff Hansen', 'oldOrganization': 'National Institute of Public Health, University of Southern Denmark'}}}}