Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT02893566
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mi Band Step Challenge to Improve Body Composition in Overweight University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group pretest-midtest-posttest design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-05', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-regulation questionnaire', 'timeFrame': 'Change from baseline self-regulation at 6 weeks and 12 weeks'}, {'measure': 'Self-efficacy for physical activity questionnaire', 'timeFrame': 'Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks'}, {'measure': 'Self-efficacy for reducing sedentary behavior questionnaire', 'timeFrame': 'Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Change from baseline weight at 6 weeks and 12 weeks', 'description': 'Weight was measured by ioi 353 body composition analyzer (Jawon Medical)'}, {'measure': 'Waist circumference (WC)', 'timeFrame': 'Change from baseline waist circumference at 6 weeks and 12 weeks', 'description': 'Waist circumference (nearest 0.1 cm) was measured in duplicate with a non-expandable tape at the midpoint between the lowest rib and the iliac crest. A third measurement was taken if the first two differed by 1 cm.'}, {'measure': 'Soft lean mass (SLM)', 'timeFrame': 'Change from baseline soft lean mass at 6 weeks and 12 weeks', 'description': 'Soft lean mass was measured by ioi 353 body composition analyzer (Jawon Medical)'}, {'measure': 'Mass of body fat (MBF)', 'timeFrame': 'Change from baseline mass of body fat at 6 weeks and 12 weeks', 'description': 'Mass of body fat was measured by ioi 353 body composition analyzer (Jawon Medical)'}, {'measure': 'Percent body fat (PBF)', 'timeFrame': 'Change from baseline percent body fat at 6 weeks and 12 weeks', 'description': 'Percent body fat was measured by ioi 353 body composition analyzer (Jawon Medical)'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Change from baseline body mass index at 6 weeks and 12 weeks', 'description': 'Body mass index was computed as average weight (kg)/average height (m2)'}, {'measure': 'Waist to hip ratio (WHR)', 'timeFrame': 'Change from baseline waist to hip ratio at 6 weeks and 12 weeks', 'description': 'Waist to hip ratio was measured by ioi 353 body composition analyzer (Jawon Medical)'}], 'secondaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'Change from baseline physical activity at 6 weeks and 12 weeks', 'description': 'Physical activity was assessed by International Physical Activity Questionnaire (Taiwan) short-form (IPAQ-SF)'}, {'measure': 'Sedentary behavior', 'timeFrame': 'Change from baseline sedentary behavior at 6 weeks and 12 weeks', 'description': "Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ)"}, {'measure': 'Daily steps', 'timeFrame': 'Change from baseline daily steps at 6 weeks and 12 weeks', 'description': 'Daily steps was assessed by Mi Band (Xiaomi Inc.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overweight', 'body mass index', 'university students', 'physical activity', 'sedentary behavior', 'body composition', 'Mi Band'], 'conditions': ['Intervention Study', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'This is an eight-month research project using one group pretest-midst-posttest design. This study is based on self-efficacy and self-regulation of Social Cognitive Theory. The investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above at one university campus. Participation is completely voluntary. After pretesting, a 12-week "Mi Band Step Challenge" will be launched immediately. Participants will be assessed with the validated instruments of International Physical Activity Questionnaire (IPAQ)-Taiwan short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and self-regulation questionnaires. Mi Band activity trackers will be used to monitor step counts. An ioi 353 body composition analyzer will be used to assess body composition. Data will be analyzed using generalized estimating equation (GEE).\n\nThe expected outcomes of this study include: (1) "Mi Band Step Challenge" will be developed based on the theory, which is expected to be effective. If this is true, the intervention can be packaged and applied at different types of colleges and universities with overweight students. (2) "Mi Band Step Challenge" has the potential to be used for the reference of the healthy weight - physical activity, which is embedded in the School Health Promotion Program executed by the Ministry of Education. (3) The result of this study can serve as an example for the promotion of evidence-based health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University students with a body mass index of 24 kg/m2 or above at one university campus.\n* No physical limitations that would prevent them from performing physical activity.\n* Not currently pregnant women.\n* Having a smart phone that would allow them to connect to a Mi Band.\n\nExclusion Criteria:\n\n* The university student who expects to be absent for more than 2 weeks or expects a suspension or transferring to another school during the implementation of the intervention.'}, 'identificationModule': {'nctId': 'NCT02893566', 'briefTitle': 'Mi Band Step Challenge to Improve Body Composition in Overweight University Students', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Effects of A Mi Band Step Challenge on Improving Physical Activity, Sedentary Behavior, and Body Composition in Overweight University Students', 'orgStudyIdInfo': {'id': '105-2815-C-039-030-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mi Band Step Challenge', 'interventionNames': ['Behavioral: Mi Band Step Challenge']}], 'interventions': [{'name': 'Mi Band Step Challenge', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mi Band Step Challenge']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yun-Ping Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'China Medical University, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lin, Yun-Ping', 'investigatorAffiliation': 'China Medical University, Taiwan'}}}}