Mi Band Step Challenge to Improve Body Composition in Overweight University Students
Primary Purpose
Intervention Study, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mi Band Step Challenge
Sponsored by

About this trial
This is an interventional prevention trial for Intervention Study focused on measuring overweight, body mass index, university students, physical activity, sedentary behavior, body composition, Mi Band
Eligibility Criteria
Inclusion Criteria:
- University students with a body mass index of 24 kg/m2 or above at one university campus.
- No physical limitations that would prevent them from performing physical activity.
- Not currently pregnant women.
- Having a smart phone that would allow them to connect to a Mi Band.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mi Band Step Challenge
Arm Description
Outcomes
Primary Outcome Measures
Weight
Weight was measured by ioi 353 body composition analyzer (Jawon Medical)
Waist circumference (WC)
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.
Soft lean mass (SLM)
Soft lean mass was measured by ioi 353 body composition analyzer (Jawon Medical)
Mass of body fat (MBF)
Mass of body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Percent body fat (PBF)
Percent body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Body mass index (BMI)
Body mass index was computed as average weight (kg)/average height (m2)
Waist to hip ratio (WHR)
Waist to hip ratio was measured by ioi 353 body composition analyzer (Jawon Medical)
Secondary Outcome Measures
Physical activity
Physical activity was assessed by International Physical Activity Questionnaire (Taiwan) short-form (IPAQ-SF)
Sedentary behavior
Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ)
Daily steps
Daily steps was assessed by Mi Band (Xiaomi Inc.)
Full Information
NCT ID
NCT02893566
First Posted
August 29, 2016
Last Updated
August 5, 2017
Sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02893566
Brief Title
Mi Band Step Challenge to Improve Body Composition in Overweight University Students
Official Title
Effects of A Mi Band Step Challenge on Improving Physical Activity, Sedentary Behavior, and Body Composition in Overweight University Students
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 29, 2016 (Actual)
Primary Completion Date
January 5, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
The 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervention Study, Physical Activity
Keywords
overweight, body mass index, university students, physical activity, sedentary behavior, body composition, Mi Band
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group pretest-midtest-posttest design
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mi Band Step Challenge
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mi Band Step Challenge
Primary Outcome Measure Information:
Title
Weight
Description
Weight was measured by ioi 353 body composition analyzer (Jawon Medical)
Time Frame
Change from baseline weight at 6 weeks and 12 weeks
Title
Waist circumference (WC)
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.
Time Frame
Change from baseline waist circumference at 6 weeks and 12 weeks
Title
Soft lean mass (SLM)
Description
Soft lean mass was measured by ioi 353 body composition analyzer (Jawon Medical)
Time Frame
Change from baseline soft lean mass at 6 weeks and 12 weeks
Title
Mass of body fat (MBF)
Description
Mass of body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Time Frame
Change from baseline mass of body fat at 6 weeks and 12 weeks
Title
Percent body fat (PBF)
Description
Percent body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Time Frame
Change from baseline percent body fat at 6 weeks and 12 weeks
Title
Body mass index (BMI)
Description
Body mass index was computed as average weight (kg)/average height (m2)
Time Frame
Change from baseline body mass index at 6 weeks and 12 weeks
Title
Waist to hip ratio (WHR)
Description
Waist to hip ratio was measured by ioi 353 body composition analyzer (Jawon Medical)
Time Frame
Change from baseline waist to hip ratio at 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
Physical activity was assessed by International Physical Activity Questionnaire (Taiwan) short-form (IPAQ-SF)
Time Frame
Change from baseline physical activity at 6 weeks and 12 weeks
Title
Sedentary behavior
Description
Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ)
Time Frame
Change from baseline sedentary behavior at 6 weeks and 12 weeks
Title
Daily steps
Description
Daily steps was assessed by Mi Band (Xiaomi Inc.)
Time Frame
Change from baseline daily steps at 6 weeks and 12 weeks
Other Pre-specified Outcome Measures:
Title
Self-regulation questionnaire
Time Frame
Change from baseline self-regulation at 6 weeks and 12 weeks
Title
Self-efficacy for physical activity questionnaire
Time Frame
Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks
Title
Self-efficacy for reducing sedentary behavior questionnaire
Time Frame
Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
University students with a body mass index of 24 kg/m2 or above at one university campus.
No physical limitations that would prevent them from performing physical activity.
Not currently pregnant women.
Having a smart phone that would allow them to connect to a Mi Band.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Ping Lin, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Mi Band Step Challenge to Improve Body Composition in Overweight University Students
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