Intervention StudyNCT02893566
Mi Band Step Challenge to Improve Body Composition in Overweight University Students
A study testing Mi Band Step Challenge in people with Intervention Study and Physical Activity, run by China Medical University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention Study, Physical Activity
- What is being tested?
- Mi Band Step Challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2016to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Intervention Study, Physical Activity
- Being tested
- Mi Band Step Challenge
- Keywords
- overweight, body mass index, university students, physical activity, sedentary behavior, body composition, Mi Band
- Medical subject headings
- Motor Activity, Overweight, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi Band Step ChallengeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mi Band Step Challenge | Experimental | Not described Receives: Behavioral: Mi Band Step Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight was measured by ioi 353 body composition analyzer (Jawon Medical)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline waist to hip ratio at 6 weeks and 12 weeks
Secondary outcomes (3)
Physical activity
Physical activity was assessed by International Physical Activity Questionnaire (Taiwan) short-form (IPAQ-SF)
Measured: Change from baseline physical activity at 6 weeks and 12 weeks
Sedentary behavior
Sedentary behavior was assessed by Rosenberg's Sedentary Behavior Questionnaire (SBQ)
Measured: Change from baseline sedentary behavior at 6 weeks and 12 weeks
Daily steps
Daily steps was assessed by Mi Band (Xiaomi Inc.)
Measured: Change from baseline daily steps at 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start29 Sep 2016
- Primary completion5 Jan 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention StudyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group pretest-midtest-posttest design
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
- Responsible party
- Principal investigator, Lin, Yun-Ping, China Medical University, Taiwan
- Investigators
- Yun-Ping Lin, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893566
- Sponsor's protocol ID
- 105-2815-C-039-030-B
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A Mi Band Step Challenge on Improving Physical Activity, Sedentary Behavior, and Body Composition in Overweight University Students
- ClinicalTrials.gov ID
- NCT02893566
- Acronym / sponsor ID
- 105-2815-C-039-030-B
- Conditions
- Intervention Study, Physical Activity
- Keywords
- overweight, body mass index, university students, physical activity, sedentary behavior, body composition, Mi Band
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pretest-midtest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Mi Band Step Challenge | Experimental | Behavioral: Mi Band Step Challenge |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi Band Step Challenge | Behavioural | Mi Band Step Challenge |
Primary outcome
Weight
Time frame: Change from baseline weight at 6 weeks and 12 weeks
Weight was measured by ioi 353 body composition analyzer (Jawon Medical)
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.
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)
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)
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)
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)
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)
3 secondary outcomes
Physical activity
Time frame: 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
Daily steps
Time frame: Change from baseline daily steps at 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Ping Lin, PhD principal investigator
China Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Mi Band Step Challenge in people with Intervention Study and Physical Activity, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Change from baseline weight at 6 weeks and 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.