Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-24 @ 6:33 PM
Study NCT ID:
NCT03061357
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Intervention Among College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072936', 'term': 'Fitness Trackers'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All participants in both intervention and control arms were not disclosed to the specific purpose of the study in order to prevent the subject-expectancy effects on study outcomes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in objectively measured physical activity to 15 weeks', 'timeFrame': 'baseline and 15 weeks', 'description': 'Physical activity was objectively measured using an ActiGraph Actitrainer (ActiGraph LLC, Pensacola, FL, USA) accelerometer.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in subjectively measured physical activity', 'timeFrame': 'baseline and 15 weeks', 'description': 'Physical activity was subjectively measured using International Physical Activity Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['activity tracker', 'behavior change'], 'conditions': ['Physical Activity']}, 'descriptionModule': {'briefSummary': 'This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students.', 'detailedDescription': 'This project was a cluster randomized trial examining the effects of utilizing a wearable activity tracker in a credit-based Physical Activity Instructional Program on promoting habitual levels of physical activity (PA) in college students.\n\nThe project was conducted in a large public university located in the mid-south region of the US. The university offers more than one hundred 1-credit hour PAIPs per academic semester. Considering the pilot nature of the study, the target PAIPs was limited to those meeting the following inclusion criteria: 1) PAIP with a size of 30 students that generally show an approximately equal gender distribution; and 2) PAIP that delivers the principles and practice of individually tailored habitual activity plans. The investigators randomly selected 14 eligible PAIPs and assigned them into intervention (k=7) and control (k=7) groups. The outcome measures of interests were the changes in objectively and subjectively measured physical activity over an academic semester.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy college students who were enrolled in 1-credit physical activity instruction programs.\n\nExclusion Criteria:\n\n* did not wish to participate;\n* have currently used their own wearable activity tracker;\n* indicated any major physical, psychiatric, or cardiovascular-related problems diagnosed by a physician.'}, 'identificationModule': {'nctId': 'NCT03061357', 'briefTitle': 'Physical Activity Intervention Among College Students', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Incorporating Wearable Technology Into Physical Activity Instructional Program: A Cluster Randomized Trial in University Settings', 'orgStudyIdInfo': {'id': '505314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activity tracker group', 'description': 'Participants in intervention arm were provided with a small and lightweight activity tracker, Misfit Flash (Misfit Wearables Co., Burlingame, CA), that can be worn with a clasp or watch band. A handout detailing the step-by-step instructions for utilizing the activity tracker with Misfit App on their smartphone was provided. There was no intervention component mandated in the curriculum of intervention PAIP courses; rather, participants were continuously encouraged by the instructors to track their activity levels and use all the features in Misfit App on a daily basis as they learned health benefits of PA and as to how to develop individualized, life-long PA plan during the course of semester.', 'interventionNames': ['Behavioral: Activity tracker']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in control arm did not receive any additional instructions other than the scheduled class activities based on the standardized core-curriculum of PAIP'}], 'interventions': [{'name': 'Activity tracker', 'type': 'BEHAVIORAL', 'description': 'Misfit Flash (Misfit Wearables Co., Burlingame, CA) activity tracker', 'armGroupLabels': ['Activity tracker group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Youngdeok Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Youngdeok Kim', 'investigatorAffiliation': 'Texas Tech University'}}}}