UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034369 |
|---|---|
| Receipt number | R000039176 |
| Scientific Title | Identifying psychological mediator bridging health promotion manga and its educational effects |
| Date of disclosure of the study information | 2018/10/03 |
| Last modified on | 2021/05/08 00:09:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identifying psychological mediator bridging health promotion manga and its educational effects
Acronym
Psychological mediator of health promotion manga effects
Scientific Title
Identifying psychological mediator bridging health promotion manga and its educational effects
Scientific Title:Acronym
Psychological mediator of health promotion manga effects
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was identifying psychological mediators that bridging the effect of health education manga to encourage physical activity and healthy eating.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Assessment of health education manga presented
(2)Changes in the reading of the health education manga presented (intention, self efficacy, knowledge, attitude, subjective norm, recall, motivation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education manga 1 (intervention): adaption of the new healthy behavior
Interventions/Control_2
Health education manga 2 (intervention): habit formation
Interventions/Control_3
Health education manga 3 (intervention): relapse prevention
Interventions/Control_4
Newsletter 1 (Control): Graphic effect only
Interventions/Control_5
Newsletter 2 (Control): Narrative effect only
Interventions/Control_6
Newsletter 3 (Control): General information
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) adulthood
(2) 20-69yr
Key exclusion criteria
Participants who did not meet inclusion criteria
Target sample size
1656
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shimazaki |
Organization
Sophia University
Division name
Faculty of Humanities, Department of Health and Physical Education
Zip code
Address
7-1 Kioi-cho, Chiyoda-ku, Tokyo, 102-8554, Japan
TEL
03-3238-3674
t-shimazaki-3k8@sophia.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Shimazaki |
Organization
Sophia University
Division name
Faculty of Humanities, Department of Health and Physical Education
Zip code
Address
7-1 Kioi-cho, Chiyoda-ku, Tokyo, 102-8554, Japan
TEL
03-3238-3674
Homepage URL
t-shimazaki-3k8@sophia.ac.jp
Sponsor or person
Institute
Sophia University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
| 2018 | Year | 10 | Month | 03 | 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
1680
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
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 03 | Day |
Last modified on
| 2021 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039176
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
