UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061520 |
|---|---|
| Receipt number | R000070294 |
| Scientific Title | Development of a health education program to improve health numeracy among high school students |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/11 12:18:37 |
* 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
Health education program study to improve health numeracy among high school students
Acronym
High school health numeracy education program study
Scientific Title
Development of a health education program to improve health numeracy among high school students
Scientific Title:Acronym
High school health numeracy education program study
Region
| Japan |
Condition
Condition
Infectious disease prevention and health numeracy among high school students
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a 40-minute educational intervention on infectious disease prevention and health numeracy among first-year high school students. Outcomes include health numeracy, risk perception related to infectious diseases, self-efficacy, and preventive behavioral intention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Health numeracy score measured before and after the intervention
Key secondary outcomes
Risk perception related to infectious diseases, self-efficacy, and preventive behavioral intention measured before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group receive a 40-minute health education program on infectious disease prevention and health numeracy. The program covers information on infectious disease prevention, understanding risk, interpreting numerical health information, and decision-making regarding preventive behaviors.
Interventions/Control_2
Participants in the control group do not receive the additional health education program developed for this study during the study period and receive usual school education.
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
First-year students enrolled in participating high schools
Students who provide consent to participate in the study
Students who are able to complete both pre- and post-intervention questionnaires
Key exclusion criteria
Students who do not provide consent to participate in the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Miyoshi |
Organization
Nihon University School of Medicine
Division name
Division of Public Health, Department of Social Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo Japan
TEL
03-5801-6043
miyoshi.tomomi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Miyoshi |
Organization
Nihon University School of Medicine
Division name
Division of Public Health, Department of Social Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-5801-6043
Homepage URL
miyoshi.tomomi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nihon University School of Medicine
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
med.kenjim@nihon-u.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
日本国内の参加高等学校
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 11 | 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
556
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
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070294
