UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048953 |
|---|---|
| Receipt number | R000051511 |
| Scientific Title | Consideration of using nudge leaflets to inform university students of learning opportunities |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/02/17 18:05:02 |
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Basic information
Public title
Consideration of using nudge leaflets to inform university students of learning opportunities
Acronym
Consideration of using nudge leaflets to inform university students of learning opportunities
Scientific Title
Consideration of using nudge leaflets to inform university students of learning opportunities
Scientific Title:Acronym
Consideration of using nudge leaflets to inform university students of learning opportunities
Region
| Japan |
Condition
Condition
Health literacy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the motivation to participate due to the different nudges used in the flyers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Willingness to participate in the symposium (behavior change stage): Evaluated outcomes are as follows ; "No interest" "Interested but not enough to participate" "Willing to participate"
Key secondary outcomes
Impressions of the flyers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Flyer without nudges
Interventions/Control_2
Flyer with Easy-type nudge
Interventions/Control_3
Flyer with EAST-type nudge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All students of A university
Key exclusion criteria
Nothing
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takebayashi |
Organization
Aomori University of Health and Welfare
Division name
Graduate school of Health Science
Zip code
0308505
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, Japan
TEL
09036442115
1691001@ms.auhw.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Yoshiike |
Organization
Aomori University of Health and Welfare
Division name
Graduate school of Health Science
Zip code
030-8505
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, Japan
TEL
017-765-4169
Homepage URL
n_yoshiike@auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aomori University of Health and Welfare IRB
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, 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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kenkokyoiku/30/3/30_300305/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kenkokyoiku/30/3/30_300305/_article/-char/ja
Number of participants that the trial has enrolled
714
Results
70 participants in the control group, 67 in the Easy nudge group, and 71 in the EAST nudge group were included in the analysis. Willingness to participate: 30.0%, 40.3%, and 47.9%, respectively. 37.1%, 82.1%, and 73.2% of the respondents in the "easy to read" and 10.0%, 26.9%, and 39.4% in the "wanted to read immediately".
Results date posted
| 2022 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
All undergraduate students at University A
Participant flow
Randomly assign students to three groups according to their student ID numbers and send them emails.
Adverse events
Nothing
Outcome measures
Willingness to participate in the symposium and feedback on the flyer
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 11 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 11 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 03 | Day |
Other
Other related information
Published
https://www.jstage.jst.go.jp/article/kenkokyoiku/30/3/30_300305/_pdf/-char/ja
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051511
