UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055573 |
|---|---|
| Receipt number | R000063503 |
| Scientific Title | An Empirical Study on Support Tools for Preconception Health Knowledge and Behaviors among Young People |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/20 18:29:07 |
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Basic information
Public title
An Empirical Study on Support Tools for Preconception Health Knowledge and Behaviors among Young People
Acronym
An Empirical Study on Support Tools for Preconception Health Knowledge and Behaviors among Young People
Scientific Title
An Empirical Study on Support Tools for Preconception Health Knowledge and Behaviors among Young People
Scientific Title:Acronym
An Empirical Study on Support Tools for Preconception Health Knowledge and Behaviors among Young People
Region
| Japan |
Condition
Condition
Health Promotion
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of the developed tools by implementing them with young people: the Word Wolf game designed to learn about preconception care and the 'National Precon Test,' a quiz that includes knowledge and behavior-related questions. The study aims to assess the knowledge and behaviors before and after the intervention to determine the utility of these tools.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knowledge and Behaviour
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will implement the Word Wolf game, designed to teach young people about preconception care, along with the 'National Precon Test,' which includes a knowledge quiz, video viewing, and behavior-related questions (quiz).
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
| 15 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)"Males and females in their late teens to twenties"
2)"Those who have provided written consent to participate in this study"
Key exclusion criteria
1. "Those who did not consent to participate in this study"
2. "Those whom the principal investigator deems unsuitable for participation in this study"
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Ota |
Organization
St. Luke's International University
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku Tokyo
TEL
0355502374
ota@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Ota |
Organization
St.Luke's International University
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku Tokyo
TEL
03-5550-2374
Homepage URL
ota@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Industry-Academia Collaboration Hub Creation Project F/S Survey Commissioned Project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Luke's International University
Address
10-1 Akashicho Chuo-ku Tokyo
Tel
0355502374
ota@slcn.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
| 2024 | Year | 09 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 16 | 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 | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063503
