Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 4:39 PM
Study NCT ID:
NCT05978869
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gamified Fitness Training to Promote Children's Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical activity levels', 'timeFrame': 'week 0', 'description': "PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists."}, {'measure': 'Learning Self-Efficacy', 'timeFrame': 'week 0', 'description': 'Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.'}, {'measure': 'physical activity levels', 'timeFrame': 'week 6', 'description': "PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists."}, {'measure': 'physical activity levels', 'timeFrame': 'week 12', 'description': "PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists."}, {'measure': 'Learning Self-Efficacy', 'timeFrame': 'week 12', 'description': 'Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction levels', 'timeFrame': 'Week 12', 'description': 'For the satisfaction of the PA program, the evaluation was conducted at the 12-week, encompassing five aspects: the integration of physical training into the HE classes, the content of the physical training, the application of gamification strategies in training, the active play during class breaks, and the effectiveness of GHPT in improving PA. Responses to levels of satisfaction with the training program were assessed across five categories: very satisfied, satisfied, OK, dissatisfied, and extremely dissatisfied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity Levels']}, 'descriptionModule': {'briefSummary': 'The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children.', 'detailedDescription': "A cluster experimental design was conducted in a small-scale context of school children. Participants were recruited by inviting two elementary schools located in the same district area for testing the physical fitness training effects. Two schools were randomly assigned to either the training group (TG; n = 47) receiving physical fitness training or the control group (CG; n = 44) without the training. Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team from the TG school. PA outcome indicators were assessed using AI-wireless sensors attached to participants' wrists over 12 weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified physical fitness training in health education classes. Data collection occurred during school days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week (T3). Generalized estimating equation statistics were used to assess the program effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* school children in 5th grade\n\nExclusion Criteria:\n\n* physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.'}, 'identificationModule': {'nctId': 'NCT05978869', 'briefTitle': "Gamified Fitness Training to Promote Children's Physical Activity", 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': "The Effectiveness of Gamified Fitness Training Integrated Into Health Education to Promote Children's Physical Activity", 'orgStudyIdInfo': {'id': 'A-ER-106-441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'physical fitness training', 'description': 'The training group received physical fitness training for 12 weeks', 'interventionNames': ['Other: physical fitness training']}, {'type': 'NO_INTERVENTION', 'label': 'No training group', 'description': 'The no training group did not receive any training program'}], 'interventions': [{'name': 'physical fitness training', 'type': 'OTHER', 'description': 'Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.', 'armGroupLabels': ['physical fitness training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi-Jane Wang', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Chi-Jane Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chi-Jane Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chi-Jane Wang', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}