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

NCT02893566 | Completed DMC

• 1 other identifier: 105-2815-C-039-030-B
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intervention Study; Physical Activity

Keywords

overweight; body mass index; university students; physical activity; sedentary behavior; body composition; Mi Band

Outcome Measures

Primary Outcomes (7)

• Weight

  Weight was measured by ioi 353 body composition analyzer (Jawon Medical)

  Change from baseline weight at 6 weeks and 12 weeks

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Physical activity

  Change from baseline physical activity at 6 weeks and 12 weeks

• Sedentary behavior

  Change from baseline sedentary behavior at 6 weeks and 12 weeks

• Daily steps

  Change from baseline daily steps at 6 weeks and 12 weeks

Other Outcomes (3)

• Self-regulation questionnaire

  Change from baseline self-regulation at 6 weeks and 12 weeks

• Self-efficacy for physical activity questionnaire

  Change from baseline self-efficacy for physical activity at 6 weeks and 12 weeks

• Self-efficacy for reducing sedentary behavior questionnaire

  Change from baseline self-efficacy for reducing sedentary behavior at 6 weeks and 12 weeks

Study Arms (1)

Mi Band Step Challenge

EXPERIMENTAL

Behavioral: Mi Band Step Challenge

Interventions

Mi Band Step Challenge BEHAVIORAL

Mi Band Step Challenge

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• China Medical University, Taiwan: collaborator

MeSH Terms

Conditions

Motor Activity; Overweight; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun-Ping Lin, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One group pretest-midtest-posttest design

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: September 29, 2016
• Primary Completion: January 5, 2017
• Study Completion: February 28, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08