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

August 5, 2017 updated by: Lin, Yun-Ping, China Medical University Hospital

Effects of A Mi Band Step Challenge on Improving Physical Activity, Sedentary Behavior, and Body Composition in Overweight University Students

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mi Band Step Challenge
Behavioral: Mi Band Step Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Change from baseline weight at 6 weeks and 12 weeks
Weight was measured by ioi 353 body composition analyzer (Jawon Medical)
Change from baseline weight at 6 weeks and 12 weeks
Waist circumference (WC)
Time Frame: Change from baseline waist circumference at 6 weeks and 12 weeks
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.
Change from baseline waist circumference at 6 weeks and 12 weeks
Soft lean mass (SLM)
Time Frame: Change from baseline soft lean mass at 6 weeks and 12 weeks
Soft lean mass was measured by ioi 353 body composition analyzer (Jawon Medical)
Change from baseline soft lean mass at 6 weeks and 12 weeks
Mass of body fat (MBF)
Time Frame: Change from baseline mass of body fat at 6 weeks and 12 weeks
Mass of body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Change from baseline mass of body fat at 6 weeks and 12 weeks
Percent body fat (PBF)
Time Frame: Change from baseline percent body fat at 6 weeks and 12 weeks
Percent body fat was measured by ioi 353 body composition analyzer (Jawon Medical)
Change from baseline percent body fat at 6 weeks and 12 weeks
Body mass index (BMI)
Time Frame: Change from baseline body mass index at 6 weeks and 12 weeks
Body mass index was computed as average weight (kg)/average height (m2)
Change from baseline body mass index at 6 weeks and 12 weeks
Waist to hip ratio (WHR)
Time Frame: Change from baseline waist to hip ratio at 6 weeks and 12 weeks
Waist to hip ratio was measured by ioi 353 body composition analyzer (Jawon Medical)
Change from baseline waist to hip ratio at 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Change from baseline physical activity at 6 weeks and 12 weeks
Physical activity was assessed by International Physical Activity Questionnaire (Taiwan) short-form (IPAQ-SF)
Change from baseline physical activity at 6 weeks and 12 weeks
Sedentary behavior
Time Frame: Change from baseline sedentary behavior at 6 weeks and 12 weeks
Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ)
Change from baseline sedentary behavior at 6 weeks and 12 weeks
Daily steps
Time Frame: Change from baseline daily steps at 6 weeks and 12 weeks
Daily steps was assessed by Mi Band (Xiaomi Inc.)
Change from baseline daily steps at 6 weeks and 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Self-regulation questionnaire
Time Frame: Change from baseline self-regulation at 6 weeks and 12 weeks
Change from baseline self-regulation at 6 weeks and 12 weeks
Self-efficacy for physical activity questionnaire
Time Frame: Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks
Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks
Self-efficacy for reducing sedentary behavior questionnaire
Time Frame: Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks
Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

Ministry of Science and Technology, Taiwan
China Medical University, Taiwan

Investigators

  • Principal Investigator: Yun-Ping Lin, PhD, China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2016

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 5, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105-2815-C-039-030-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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