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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
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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

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    Mi Band Step Challenge to Improve Body Composition in Overweight University Students

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