Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT04122950
Status:
TERMINATED
Last Update Posted:
2022-04-07
First Post:
2019-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088544', 'term': 'Exergaming'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Few interested participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily time physical activity (moderate, vigorous and very vigorous)', 'timeFrame': '12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Daily average energy expenditure', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily average number of steps', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily time in vigorous intensity activity', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Daily average total physical activity duration', 'timeFrame': '8 and 12 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.'}, {'measure': 'Bioelectrical impedance', 'timeFrame': '8 and 12 weeks', 'description': 'Body composition assessed using bioelectrical impedance analysis (InBody 720)'}, {'measure': 'Blood Pressure', 'timeFrame': '8 and 12 weeks'}, {'measure': 'Fasting circulating glucose, as blood marker of cardiometabolic health', 'timeFrame': '8 and 12 weeks'}, {'measure': 'Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health', 'timeFrame': '8 and 12 weeks'}, {'measure': 'Circulating insulin concentration, as blood marker of cardiometabolic health', 'timeFrame': '8 and 12 weeks'}, {'measure': 'glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health', 'timeFrame': '8 and 12 weeks'}, {'measure': 'VO2max', 'timeFrame': '8 and 12 weeks', 'description': 'Maximal Aerobic Capacity'}, {'measure': 'Daily time physical activity (moderate, vigorous and very vigorous)', 'timeFrame': '8 weeks', 'description': 'Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Physical fitness', 'Gaming', 'Child', 'Healthy lifestyle', 'Fitness testing'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). We also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up.\n\nAlso, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. Aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Defined as overweight/obese for age and sex\n* Able to ride a bike for up to 60 minutes\n\nExclusion Criteria:\n\n* Known cardiovascular disease\n* Taking beta-blockers or anti-arrhythmic drugs\n* Other diseases that restrict them from doing High-Intensity Training'}, 'identificationModule': {'nctId': 'NCT04122950', 'briefTitle': 'Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents', 'orgStudyIdInfo': {'id': '2019/1082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exergaming', 'description': 'The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions', 'interventionNames': ['Behavioral: Exergaming']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Continue with normal daily routine.'}], 'interventions': [{'name': 'Exergaming', 'type': 'BEHAVIORAL', 'description': 'The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions', 'armGroupLabels': ['Exergaming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Circulation and Medical Imaging', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øystein Risa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Trine Moholdt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}