UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022816 |
|---|---|
| Receipt number | R000026300 |
| Scientific Title | Assessment of dietary change after health instruction using self-monitoring devices |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2018/07/17 20:12:20 |
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Basic information
Public title
Assessment of dietary change after health instruction using self-monitoring devices
Acronym
Assessment of dietary change after health instruction using self-monitoring devices
Scientific Title
Assessment of dietary change after health instruction using self-monitoring devices
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Atsushi Hozawa |
Organization
Tohoku Medical Megabank Organization,
Tohoku University
Division name
Personalized prevention and epidemiology
Zip code
Address
2-1 Seiryomachi, Aobaku, Sendai, Japan
TEL
022-273-6212
hozawa-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Hozawa |
Organization
Tohoku Medical Megabank Organization,
Division name
Personalized prevention and epidemiology
Zip code
Address
2-1 Seiryomachi, Aobaku, Sendai, Japan
TEL
022-273-6212
Homepage URL
hozawa-thk@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026300
