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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029395
Receipt No. R000033485
Scientific Title Investigation of effect on blood pressure and weight improvement by blood pressure measurement and dietary intervention
Date of disclosure of the study information 2017/10/03
Last modified on 2018/03/16

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Basic information
Public title Investigation of effect on blood pressure and weight improvement by blood pressure measurement and dietary intervention
Acronym Investigation of effect on blood pressure and weight improvement by blood pressure measurement and dietary intervention
Scientific Title Investigation of effect on blood pressure and weight improvement by blood pressure measurement and dietary intervention
Scientific Title:Acronym Investigation of effect on blood pressure and weight improvement by blood pressure measurement and dietary intervention
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect on blood pressure and weight improvement by blood pressure measurement and diet intervention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in average systolic blood pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
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 In addition to blood pressure and weight measurement every morning and evening, diet coaching will be conducted as below:
3 times a day for the first one week
once a week for 3 months
once a month for the last 3 months
Interventions/Control_2 In addition to blood pressure and weight measurement every morning and evening, diet coaching will be conducted as below:
3 times a day for the first one week
once a month for 6 months
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 1. People who have 130-179 mmHg in systolic blood pressure and/or 85-109 mmHg in diastolic blood pressure
2. People who are 20 or more years old when obtaining informed consent, and are able to give informed consent
Key exclusion criteria 1. People who are under treatment for hypertension
2. People who are under intervention of diet
3. People who suffer from any malignant diseases
4. People who have any serious liver/kidney/heart/brain diseases
5. People who are in pregnancy or during lactation
6. People who are judged as inappropriate to be enrolled into this study due to safety by a medical doctor or any Sponsor
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Akimoto
Organization Panasonic Corporation
Division name Business Development Center, Appliances Company
Zip code
Address 4F Hamamatsu-Cho Bldg. 1-17-14 Hamamatsu-cho, Minato-ku, Tokyo
TEL 03-6403-3255
Email akimoto.nobuhiro@jp.panasonic.com

Public contact
Name of contact person
1st name
Middle name
Last name NA
Organization FiNC, Inc.
Division name FiNC Support Center
Zip code
Address 5F Shin-Yurakucho Building, 1-12-1 Yuraku-cho, Chiyoda-ku, Tokyo
TEL 0120-27-8080
Homepage URL
Email support-fincapp@finc.com

Sponsor
Institute Panasonic Corporation
Business Development Center, Appliances Company
Institute
Department

Funding Source
Organization Panasonic Corporation
Business Development Center, Appliances Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor FiNC, Inc.
National Cerebral and Cardiovascular Center
Matsushita Memorial Hospital
Name of secondary funder(s) FiNC, Inc.

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 03 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 22 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
2017 Year 10 Month 03 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033485

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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