Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-04 @ 5:46 PM
Study NCT ID:
NCT00682266
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2008-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated Diameter Maximal oxygen uptake BMI', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Overweight', 'Exercise', 'multidisciplinary approach', 'Oxygen uptake', 'Flow mediated dilatation', 'Cardiovascular Risk Factors'], 'conditions': ['Obesity', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '18673303', 'type': 'RESULT', 'citation': 'Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>+ 2SD (age adjusted)\n* Fitted for group treatment\n* at least one parent attending the treatment\n\nExclusion Criteria:\n\n* Not able to join treatment\n* not able to walk'}, 'identificationModule': {'nctId': 'NCT00682266', 'briefTitle': 'High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Reducing Cardiovascular Risk Factors In Overweight Adolescents: Multidisciplinary Treatment and Intensity Controlled Interval Training', 'orgStudyIdInfo': {'id': '251076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic interval training', 'description': 'intensity-controlled interval training', 'interventionNames': ['Behavioral: intensity controlled interval training (AIT)']}, {'type': 'EXPERIMENTAL', 'label': 'MTG', 'description': 'multidisciplinary approach', 'interventionNames': ['Behavioral: Multidisciplinary approach (MTG)']}], 'interventions': [{'name': 'intensity controlled interval training (AIT)', 'type': 'BEHAVIORAL', 'description': '4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months', 'armGroupLabels': ['Aerobic interval training']}, {'name': 'Multidisciplinary approach (MTG)', 'type': 'BEHAVIORAL', 'description': 'exercise, dietary and psychological advice, twice a month for 12 months', 'armGroupLabels': ['MTG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Rønnaug Ødegård, Dr.med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}