UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053711 |
|---|---|
| Receipt number | R000061291 |
| Scientific Title | Can Improving Health Literacy Through Leaflets Contribute to Reductions in Salt Intake: Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/04/10 |
| Last modified on | 2024/02/26 15:17:30 |
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Basic information
Public title
Can Improving Health Literacy Through Leaflets Contribute to Reductions in Salt Intake
Acronym
Improving Salt Intake through Leaflets
Scientific Title
Can Improving Health Literacy Through Leaflets Contribute to Reductions in Salt Intake: Randomized Controlled Trial
Scientific Title:Acronym
Improving Salt Intake through Leaflets
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop leaflets to improve the health literacy of university students and to evaluate the effectiveness of the leaflets in improving health literacy and reducing salt intake through a randomized controlled trial (RCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Salt Intake 3 Months After Starting the Intervention
Key secondary outcomes
At 3 months after starting the intervention, we will assess Comprehensive Health Literacy (HLS-EU-Q12 Japanese version), Salt Reduction Awareness, Perception of the risk of disease associated with salt intake, Knowledge of Disease Risk Associated with Salt Intake, Daily Use of Seasonings, Importance of Salt Reduction, Confidence in Practicing Salt Reduction, and Behavioral Change Stage for Salt Reduction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Distribute a double-sided A4-size sheet leaflet to improve health literacy. Instruct participants to register for a dedicated LINE account for the study and receive weekly leaflet review messages via LINE for three months.
Interventions/Control_2
Distribute a double-sided A4-size sheet leaflet to improve health literacy (Same leaflet as Intervention 1).
Interventions/Control_3
Distribute a double-sided A4-size leaflet on standard salt reduction. Instruct participants to register for a dedicated LINE account for the study and receive weekly leaflet review messages via LINE for three months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy men and women
Key exclusion criteria
None
Target sample size
249
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yoshiike |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Sciences
Zip code
030-8505
Address
58-1 Mase, Hamadate, Aomori City, Aomori, Japan
TEL
017-765-2000
soumuka@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Nobuya |
| Middle name | |
| Last name | Kimura |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Sciences
Zip code
030-8505
Address
58-1 Mase, Hamadate, Aomori City, Aomori, Japan
TEL
011-388-4603
Homepage URL
n-kimura@rakuno.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Aomori University of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Rakuno Gakuen University
IRB Contact (For public release)
Organization
Aomori University of Health and Welfare
Address
58-1 Mase, Hamadate, Aomori City, Aomori, Japan
Tel
017-765-2000
rinri2008@auhw.ac.jp
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
酪農学園大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061291
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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