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Completed

NCT Number: NCT02893566

Mi Band Step Challenge to Improve 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.

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Key information

Conditions

Intervention Study Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Sedentary Behavior Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mi Band Step Challenge

Behavioral

Primary outcomes

  1. Weight

    Time frame: Change from baseline weight at 6 weeks and 12 weeks

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

  2. 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.

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Daily steps

    Time frame: Change from baseline daily steps at 6 weeks and 12 weeks

    Daily steps was assessed by Mi Band (Xiaomi Inc.)

Other outcomes

  1. Self-regulation questionnaire

    Time frame: Change from baseline self-regulation at 6 weeks and 12 weeks

  2. Self-efficacy for physical activity questionnaire

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

  3. Self-efficacy for reducing sedentary behavior questionnaire

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

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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