UMIN-CTR Clinical Trial

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 Nobuhiro Middle name Last name Akimoto
Organization	Panasonic Corporation
Division name	Business Development Center, Appliances Company
Zip code	105-0013
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 Shin Middle name Last name Murakami
Organization	FiNC Technologies Inc.
Division name	FiNC Support Center
Zip code	100-0006
Address	5F Shin-Yurakucho Building, 1-12-1 Yuraku-cho, Chiyoda-ku, Tokyo
TEL	09025562467
Homepage URL
Email	shin.murakami@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	Panasonic Corporation Business Development Center, Appliances Company
Address	2-3-1-2 Nojihigashi Kusatsu-city , Shiga
Tel	077-567-9801
Email	akimoto.nobuhiro@jp.panasonic.com

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	46
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to the circumstances of company A, a joint research destination
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 09 Month 07 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 22 Day
Last follow-up date	2018 Year 08 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	2017 Year 10 Month 03 Day
Last modified on	2020 Year 09 Month 23 Day

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