UMIN-CTR Clinical Trial

Basic information
Public title	The sedentary behavior in university students and the effectiveness of intervention program to improve a sitting time.
Acronym	The sedentary behavior in university students and the effectiveness of intervention program to improve a sitting time.
Scientific Title	The sedentary behavior in university students and the effectiveness of intervention program to improve a sitting time.
Scientific Title:Acronym	The sedentary behavior in university students and the effectiveness of intervention program to improve a sitting time.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effects of a standing desk on the sitting behavior in university students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sitting time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Control phase: Evaluate the amount of physical activity and sitting time per week of normal lifestyle.
Interventions/Control_2	Intervention phase: Evaluate the amount of physical activity and sitting time per week with a standing desk.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	25 years-old >
Gender	Male and Female
Key inclusion criteria	Participants who 1) are aged over 18 years old 2) are not planned special activities during the measurement period 3) are expected to graduate for 4th grade 4) provided informed consent
Key exclusion criteria	Participants who 1) goes to school by bicycle or walk for a long time 2) have irregular lifestyle due to nighttime work or research activities 3) have ambulatory dysfunction 4) have severe medical histories
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Taketaka Middle name Last name Hara
Organization	Shimane University
Division name	Faculty of Education
Zip code	690-8504
Address	1060 Nishikawatsu-cho, Matsue, Shimane
TEL	0852-32-6340
Email	thara@edu.shimane-u.ac.jp

Public contact
Name of contact person	1st name Taketaka Middle name Last name Hara
Organization	Shimane University
Division name	Faculty of Education
Zip code	690-8504
Address	1060 Nishikawatsu-cho, Matsue, Shimane
TEL	0852-32-6340
Homepage URL
Email	thara@edu.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University Institutional Committee on Ethics
Address	89-1 Enya-cyo, Izumo-city, Shimane
Tel	0853-20-2515
Email	kenkyu@med.shimane-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	島根大学

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 23 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2019 Year 08 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 19 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043033