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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023788
Receipt No. R000026934
Scientific Title Effect of self-monitoring salt intake for salt reduction A Non-Blinded Cluster Randomized Trial
Date of disclosure of the study information 2016/08/27
Last modified on 2017/08/02

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Basic information
Public title Effect of self-monitoring salt intake for salt reduction
A Non-Blinded Cluster Randomized Trial
Acronym The effect of self-monitoring salt intake
Scientific Title Effect of self-monitoring salt intake for salt reduction
A Non-Blinded Cluster Randomized Trial
Scientific Title:Acronym The effect of self-monitoring salt intake
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of self-monitoring salt intake for salt reduction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Estimated daily salt intake by spot urine 4 weeks after intervention
Key secondary outcomes Blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Usual education for salt reduction (60 minutes lecture by a general physician and a registered dietitian) and self-monitoring salt intake by a simple device
Interventions/Control_2 Usual education for salt reduction (60 minutes lecture by a general physician and a registered dietitian)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Applicants to an advertisement by Shirakawa General Kosei Hospital, Nishigo village, Shirakawa city, and Japan agricultural Cooperative Yumeminami branch
Key exclusion criteria Families who do not live with participants
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Takada
Organization Fukushima Medical University
Division name Shirakawa Satellite for Teaching And Research in General Medicine
Zip code
Address 2-1, Toyochikamiyajiro Shirakawa, Fukushima, 961-0005
TEL 0248-22-2211
Email ttakada@water.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Takada
Organization Fukushima Medical University
Division name Shirakawa Satellite for Teaching And Research in General Medicine
Zip code
Address 2-1, Toyochikamiyajiro Shirakawa, Fukushima, 961-0005
TEL 0248-22-2211
Homepage URL
Email ttakada@water.ocn.ne.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization The Ministry of Education,Culuture,Sports,Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 白河厚生総合病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 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 Completed
Date of protocol fixation
2016 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 27 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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