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Trial registered on ANZCTR


Registration number
ACTRN12618001237279
Ethics application status
Approved
Date submitted
25/06/2018
Date registered
23/07/2018
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is the Goal of 12 000 Steps per Day Sufficient for Improving Body Composition and Metabolic Syndrome? The Necessity of Combining Exercise Intensity
Scientific title
Is the Goal of 12 000 Steps per Day Sufficient for Improving Body Composition and Metabolic Syndrome? The Necessity of Combining Exercise Intensity
Secondary ID [1] 295303 0
None'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obese 308497 0
Condition category
Condition code
Public Health 307473 307473 0 0
Health promotion/education
Diet and Nutrition 307656 307656 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty-two adults with obesity were recruited and randomly assigned to the walking step goal group (WSG; achieving 12 000 steps per day), walking exercise group (WEG; achieving 12 000 steps per day, including 3 days per week on which walking at a step rate of over 103 steps min-1 was required), or control group (CG; maintaining a free-living life style). Each participant’s accumulated daily steps from daily activities and walking exercises were monitored using a smartwatch for 8 weeks. The variables of body composition and metabolic syndrome were measured before and after intervention.
Intervention code [1] 301638 0
Prevention
Intervention code [2] 301772 0
Lifestyle
Intervention code [3] 301773 0
Behaviour
Comparator / control treatment
walking exercise group (WEG; achieving 12 000 steps per day, including 3 days per week on which walking at a step rate of over 103 steps min-1 was required)
Control group
Active

Outcomes
Primary outcome [1] 306446 0
The primary outcome was to assess the changes in body composition.
The composite body composition including the changes of weight, BMI, hip circumference, body fat, skeletal muscle mass, visceral fat area which are key criteria for assessing the body composition in obese.

device:
body composition: Bioelectrical impedance analysis (Inbody 720, Biospace Co., Ltd, Seoul, ROK)
hip circumference: tape
Timepoint [1] 306446 0
baseline and 8 weeks after
Primary outcome [2] 306665 0
The primary outcome was to assess the changes in Changes in metabolic syndrome.
The composite metabolic syndrome including waist circumference, systolic blood pressure, diastolic blood pressure, high-density lipoprotein cholesterol (HDL), fasting glucose (FG), triglycerides (TG) area which are key criteria for assessing the risk factors of cardiovascular disease in obese.

device:
HDL, FG, TG: blood analysis
blood pressure: blood pressure monitors (WatchBP Home, Microlife, Taiwan)
waist circumference: tape
Timepoint [2] 306665 0
baseline and 8 weeks after
Secondary outcome [1] 348571 0
Total Daily Steps
smart watch for step count
Timepoint [1] 348571 0
Monday to Friday (1, 2, 3, 4, 5, 6, 7, 8 weeks)
Secondary outcome [2] 349178 0
Walking Exercise Step Rate
smart watch for step count
Timepoint [2] 349178 0
The exercise program comprised a 30-min walking session in a day. 3 d/wk for 8 weeks.
Secondary outcome [3] 349179 0
the subjective perception of exercise effort
Measured by using the Borg's rating of perceived exertion (RPE; scale 6–20).
Timepoint [3] 349179 0
Before and immediately after of each exercise (1, 2, 3, 4, 5, 6, 7, 8 weeks)
Secondary outcome [4] 349655 0
Changes in waist to hip ratio.
For manual measurement used tape for measuring of waist and hip Circumference (W/ H).
Timepoint [4] 349655 0
baseline and 8 weeks after

Eligibility
Key inclusion criteria
1. BMI > 27 kg m-2
2. aged > 18 years
3. not regularly engage in physical activity
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any chronic disease, e.g. epilepsy, congenital heart disease, serious physical/psychiatric disorders, severe asthma, acute asthma exacerbations, diabetes.
2. obese adults who had a regular exercise habit (who perform physical activity 3 or more sessions per week at moderate to vigorous intensity for 30 min or above)
3. Participating in any other clinical trials

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10585 0
Taiwan, Province Of China
State/province [1] 10585 0

Funding & Sponsors
Funding source category [1] 299895 0
Government body
Name [1] 299895 0
Ministry of Science and Technology, Republic of China
Address [1] 299895 0
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C
Country [1] 299895 0
Taiwan, Province Of China
Primary sponsor type
University
Name
Chinese Culture University
Address
55, Hwa-Kang Rd., Yang-Ming-Shan, Taipei ,
Taiwan 11114, R. O. C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 299256 0
None
Name [1] 299256 0
Address [1] 299256 0
Country [1] 299256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300764 0
Human Research Ethics Committee of the Institutional Review Board of Fu Jen Catholic University
Ethics committee address [1] 300764 0
No.510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City 24205, Taiwan (R.O.C.)
Ethics committee country [1] 300764 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 300764 0
08/07/2017
Approval date [1] 300764 0
09/11/2017
Ethics approval number [1] 300764 0
C105137

Summary
Brief summary
The combination of walking exercise program and daily step goal is a more time efficient strategy in improving body composition and MS than simply establishing a daily step goal. Furthermore, this strategy may also include a potential reduction effect on the risk factors of cardiovascular diseases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84738 0
A/Prof Huey-June Wu
Address 84738 0
Department of Combat Sports and Chinese Martial Arts, Chinese Culture University
Graduate Institute of Sport Coaching Science, Chinese Culture University
55, Hwa-Kang Rd., Yang-Ming-Shan, Taipei, Taiwan 11114, R. O. C.
Country 84738 0
Taiwan, Province Of China
Phone 84738 0
886-2-2861-0511#43219
Fax 84738 0
Email 84738 0
asd7251270@gmail.com
Contact person for public queries
Name 84739 0
Dr Tsung-Lin Chiang
Address 84739 0
Graduate Institute of Sport Coaching Science, Chinese Culture University
55, Hwa-Kang Rd., Yang-Ming-Shan, Taipei, Taiwan 11114, R. O. C.
Country 84739 0
Taiwan, Province Of China
Phone 84739 0
886-2-2861-0511#43291
Fax 84739 0
Email 84739 0
asd7251270@gmail.com
Contact person for scientific queries
Name 84740 0
Dr Tsung-Lin Chiang
Address 84740 0
Graduate Institute of Sport Coaching Science, Chinese Culture University
55, Hwa-Kang Rd., Yang-Ming-Shan, Taipei, Taiwan 11114, R. O. C.
Country 84740 0
Taiwan, Province Of China
Phone 84740 0
886-2-2861-0511#43291
Fax 84740 0
Email 84740 0
asd7251270@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary