UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054761 |
|---|---|
| Receipt number | R000060391 |
| Scientific Title | Examining the intervention effect of distributing comics (educational materials) to children |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/12/25 09:13:52 |
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Basic information
Public title
Examining the intervention effect of distributing comics (educational materials) to children
Acronym
Examining the intervention effect of distributing comics (educational materials)
Scientific Title
Examining the intervention effect of distributing comics (educational materials) to children
Scientific Title:Acronym
Examining the intervention effect of distributing comics (educational materials) to children
Region
| Japan |
Condition
Condition
healthy child
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of disease education, that is, whether distributing educational materials (manga) to elementary school children without type 1 diabetes improves disease knowledge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease knowledge related to diabetes (diabetes test)
Key secondary outcomes
Physical activity (average number of steps (steps/day) and average duration of medium-to-high intensity activity (minutes/day)), CMAS Anxiety Scale for Children
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Distribution of educational materials
Interventions/Control_2
Educational lessons
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
| 8 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) People who can carry an accelerometer throughout the study period
2) Elementary school students in the 3rd to 6th grades, and junior high school students in the 1st to 3rd grades
3) People who can walk independently and have no doctor's instructions to restrict exercise
Key exclusion criteria
People who cannot walk independently or have limited movement
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba
Division name
Systems and Information Engineering
Zip code
305-8573
Address
1-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
0298536181
minaminagasaki2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba
Division name
Systems and Information Engineering
Zip code
305-8573
Address
1-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
0298536181
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
university of tsukuba
Institute
Department
Personal name
Funding Source
Organization
university of tsukuba
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
university of tsukuba
Address
1-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
Tel
0298536181
minaminagasaki2007@yahoo.co.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
| 2024 | Year | 06 | Month | 25 | 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
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060391
