UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036859
Receipt No. R000041995
Scientific Title Development of a new grogram for university students with lifestyle related disease.
Date of disclosure of the study information 2019/05/27
Last modified on 2019/05/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development of a new grogram for university students with lifestyle related disease.
Acronym Development of a new grogram for university students with lifestyle related disease.
Scientific Title Development of a new grogram for university students with lifestyle related disease.
Scientific Title:Acronym Development of a new grogram for university students with lifestyle related disease.
Region
Japan

Condition
Condition lifestyle related disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of the new program using arteriosclerosis index and personality assessment to encourage university students with lifestyle related disease to change the health behavior
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing health behavior within 12 months after starting program
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Health education
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Students at Shimane university students
2)Students diagnosed lifestyle related disease (hypertension, obesity) at health check
Key exclusion criteria 1)Students with mental illness
2)Students with medication for lifestyle related disease
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Shinobu
Middle name
Last name Sugihara
Organization Shimane university
Division name Health service center
Zip code 690-8504
Address 1060 Nishikawatsu-cho, Matsue-city, Shimane
TEL 0852-32-6568
Email shinobutozuito@soc.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinobu
Middle name
Last name Sugihara
Organization Shimane university
Division name Health service center
Zip code 690-8504
Address 1060 Nishikawatsu-cho, Matsue-city, Shimane
TEL 0852-32-6568
Homepage URL
Email shinobutozuito@soc.shimane-u.ac.jp

Sponsor
Institute Shimane university
Institute
Department

Funding Source
Organization Shimane university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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-pre.
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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 27 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 25 Day
Date of IRB
2018 Year 12 Month 25 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2023 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 05 Month 27 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.