UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057311 |
|---|---|
| Receipt number | R000065517 |
| Scientific Title | Development of a pre-conception care education program for upper elementary school students |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/09/17 10:12:23 |
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Basic information
Public title
Development of a pre-conception care education program for upper elementary school students
Acronym
Development of a pre-conception care education program for upper elementary school students
Scientific Title
Development of a pre-conception care education program for upper elementary school students
Scientific Title:Acronym
Development of a pre-conception care education program for upper elementary school students
Region
| Japan |
Condition
Condition
preconception care
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a preconception care (hereinafter referred to as PCC) educational program for upper elementary school students and to clarify its effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge of health
Willingness to learn about health
Perception of the value of health
Practice in daily life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
PCC Educational Programs
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The program will be implemented for children who have submitted a consent form.
Key exclusion criteria
Children who do not submit a consent form will be excluded from the program.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Ebina |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
N12W5, Kita-Ku, Sapporo
TEL
011-706-2822
ebiyas@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Ebina |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
N12W5,Kita-Ku, Sapporo
TEL
011-706-2822
Homepage URL
ebiyas@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Faculty of Health Sciences, Hokkaido University
Address
N12W5,Kita-Ku, Sapporo
Tel
011-706-2822
ebiyas@hs.hokudai.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
| 2025 | Year | 03 | Month | 17 | 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
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065517
