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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893566
Other study ID # 105-2815-C-039-030-B
Secondary ID
Status Completed
Phase N/A
First received August 29, 2016
Last updated August 5, 2017
Start date September 29, 2016
Est. completion date February 28, 2017

Study information

Verified date August 2017
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date February 28, 2017
Est. primary completion date January 5, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mi Band Step Challenge


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
China Medical University Hospital China Medical University, Taiwan, Ministry of Science and Technology, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Other Self-regulation questionnaire Change from baseline self-regulation at 6 weeks and 12 weeks
Other Self-efficacy for physical activity questionnaire Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks
Other Self-efficacy for reducing sedentary behavior questionnaire Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks
Primary Weight Weight was measured by ioi 353 body composition analyzer (Jawon Medical) Change from baseline weight at 6 weeks and 12 weeks
Primary 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. Change from baseline waist circumference at 6 weeks and 12 weeks
Primary Soft lean mass (SLM) 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
Primary Mass of body fat (MBF) 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
Primary Percent body fat (PBF) 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
Primary Body mass index (BMI) Body mass index was computed as average weight (kg)/average height (m2) Change from baseline body mass index at 6 weeks and 12 weeks
Primary Waist to hip ratio (WHR) 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 Physical activity 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
Secondary Sedentary behavior Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ) Change from baseline sedentary behavior at 6 weeks and 12 weeks
Secondary Daily steps Daily steps was assessed by Mi Band (Xiaomi Inc.) Change from baseline daily steps at 6 weeks and 12 weeks
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