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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029625
Receipt No. R000033831
Scientific Title Education of reduced salt diet using BGM for healthy Japanese : non-randomize control trial at worksite cafeteria
Date of disclosure of the study information 2017/10/19
Last modified on 2019/04/22

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Basic information
Public title Education of reduced salt diet using BGM for healthy Japanese : non-randomize control trial at worksite cafeteria
Acronym Education of reduced salt diet using BGM for healthy Japanese : non-randomize control trial at worksite cafeteria
Scientific Title Education of reduced salt diet using BGM for healthy Japanese : non-randomize control trial at worksite cafeteria
Scientific Title:Acronym Education of reduced salt diet using BGM for healthy Japanese : non-randomize control trial at worksite cafeteria
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy of the BGM developed by Nara prefecture for reducing sodium intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes degree of the change in sodium excretion in spot urine
Key secondary outcomes changes in the state of sodium intake on the basis of the questionnaire

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 visual materials (flags and posters) and a hearing material (BGM) 5 weeks
Interventions/Control_2 visual materials (flags and posters) 5 weeks
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
65 years-old >
Gender Male and Female
Key inclusion criteria users of their worksite cafeterias
Key exclusion criteria current use of hypertensive medicine
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Ribeka
Middle name
Last name Takachi
Organization Nara Women's University
Division name Human life and environment
Zip code 6308506
Address Kita-uoya Nishi-machi, Nara-city, Nara, Japan
TEL 0742-20-3565
Email rtakachi@cc.nara-wu.ac.jp

Public contact
Name of contact person
1st name Ribeka
Middle name
Last name Takachi
Organization Nara Women's University
Division name Human life and environment
Zip code 6308506
Address Kita-uoya Nishi-machi, Nara-city, Nara, Japan
TEL 0742-20-3565
Homepage URL
Email rtakachi@cc.nara-wu.ac.jp

Sponsor
Institute Nara Women's University
Institute
Department

Funding Source
Organization Nara Women's University
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 Nara women's university institutional review board
Address Higashi-machi Kitauoya, Nara-city, Nara
Tel 0742-20-3762
Email kenkyou@cc.nara-wu.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
2017 Year 10 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 466
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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 13 Day
Date of IRB
2017 Year 06 Month 30 Day
Anticipated trial start date
2017 Year 10 Month 20 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033831

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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