Clinical trial NCT02893566: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intervention Study
Physical Activity
Keywords: overweight
body mass index
university students
physical activity
sedentary behavior
body composition
Mi Band
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: China Medical University, Taiwan
First posted: 2016-09-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group pretest-midtest-posttest design
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Weight
timeFrame: Change from baseline weight at 6 weeks and 12 weeks
measure: Waist circumference (WC)
timeFrame: Change from baseline waist circumference at 6 weeks and 12 weeks
measure: Soft lean mass (SLM)
timeFrame: Change from baseline soft lean mass at 6 weeks and 12 weeks
measure: Mass of body fat (MBF)
timeFrame: Change from baseline mass of body fat at 6 weeks and 12 weeks
measure: Percent body fat (PBF)
timeFrame: Change from baseline percent body fat at 6 weeks and 12 weeks
measure: Body mass index (BMI)
timeFrame: Change from baseline body mass index at 6 weeks and 12 weeks
measure: Waist to hip ratio (WHR)
timeFrame: Change from baseline waist to hip ratio at 6 weeks and 12 weeks
Secondary outcomes:
measure: Physical activity
timeFrame: Change from baseline physical activity at 6 weeks and 12 weeks
measure: Sedentary behavior
timeFrame: Change from baseline sedentary behavior at 6 weeks and 12 weeks
measure: Daily steps
timeFrame: Change from baseline daily steps at 6 weeks and 12 weeks
Other outcomes:
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
Locations:
Study officials:
affiliation: China Medical University, China
name: Yun-Ping Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: