UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of dietary change after health instruction using self-monitoring devices
Title of the study (Brief title)	Assessment of dietary change after health instruction using self-monitoring devices
Region	Japan

Condition
Condition	blood pressure
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To investigate the relationship between dietary change using self-monitoring device and blood pressure change after health instruction.
Basic objectives2	Others
Basic objectives -Others	2.Assessment of dietary change after health instruction. 3. Assessment of feasibility of using self monitoring device.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	blood pressure change between 1-2w before health inctruction and 1-2w after health instruction. urinary Na/K ratio change between 1-2w before health inctruction and 1-2w after health instruction.
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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	health instruction 1 day
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	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Participants who were required to take health instruction according to the health check-up data. Systolic blood pressure(BP) 130-159 mmHg and/or diastolic BP 85-100 mmHg. Systolic BP >=160mmHg and/or diastolic BP >=100mmHg were not eligible.
Key exclusion criteria	(1) having severe complication (2) pregnant person (3) Participants who is difficult to attend this test. (4) User of antihypertensive medication
Target sample size	90

Research contact person
Name of lead principal investigator	Atsushi Hozawa
Organization	Tohoku Medical Megabank Organization, Tohoku University
Division name	Personalized prevention and epidemiology
Address	2-1 Seiryomachi, Aobaku, Sendai, Japan
TEL	022-273-6212
Email	hozawa-thk@umin.ac.jp

Public contact
Name of contact person	Atsushi Hozawa
Organization	Tohoku Medical Megabank Organization,
Division name	Personalized prevention and epidemiology
Address	2-1 Seiryomachi, Aobaku, Sendai, Japan
TEL	022-273-6212
Homepage URL
Email	hozawa-thk@umin.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Center of Innovation Science and Technology based Radical Innovation and Entrepreneurship Program
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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	2016 Year 06 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026300