UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026775 |
|---|---|
| Receipt number | R000030741 |
| Scientific Title | Advantages of using a self-monitoring device for educating female college students on salt restriction: Randomized controlled trial |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/10/11 18:24:31 |
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Basic information
Public title
Advantages of using a self-monitoring device for educating female college students on salt restriction: Randomized controlled trial
Acronym
Self-monitoring device in educating salt restriction
Scientific Title
Advantages of using a self-monitoring device for educating female college students on salt restriction: Randomized controlled trial
Scientific Title:Acronym
Self-monitoring device in educating salt restriction
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the usability of a self-monitoring device in educating female college students on salt restriction in randomized controlled trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in 24-hour urinary salt excretion at base-line and end-line
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
We ask the students to collect urine for 24-hours at base-line and end-line.
The intervention group is asked to use a self-monitoring device for 4 weeks.
Interventions/Control_2
We ask the students to collect urine for 24-hours at base-line and end-line.
The control group only receives the information of the study.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female college students
Key exclusion criteria
The exclusion criteria included subjects with physical, psychological, and social difficulties; those without the ability for self-selection and/or self-determination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
yasutake@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
Homepage URL
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen 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
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
| 2017 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030741
