UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062839 |
|---|---|
| Receipt number | R000071939 |
| Scientific Title | Effectiveness of Nudge-Based Educational Materials for Parents of Adolescent Boys on HPV-Related Disease Prevention: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/07 17:54:07 |
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Basic information
Public title
A study investigating the effectiveness of an educational material to prevent HPV (human papillomavirus)-related diseases for parents of adolescent boys: An examination of materials incorporating nudges
Acronym
Nudge-Based HPV Educational Material Study
Scientific Title
Effectiveness of Nudge-Based Educational Materials for Parents of Adolescent Boys on HPV-Related Disease Prevention: A Randomized Controlled Trial
Scientific Title:Acronym
Nudge-HPV Material RCT
Region
| Japan |
Condition
Condition
HPV-related diseases
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide a nudge-based educational material on HPV-related disease prevention to parents of adolescent boys and evaluate its effects on their intention to recommend HPV vaccination to their sons, recommendation behavior, sons' HPV vaccination status, and knowledge, attitudes, and social perceptions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intention to recommend HPV vaccination to their sons (immediately after intervention, 1 month, and 3 months post-intervention)
Key secondary outcomes
Parents' recommendation behaviors to their sons and sons' HPV vaccination status (1 month and 3 months post-intervention), knowledge, attitudes, and social perceptions regarding HPV-related diseases and vaccines (immediately after intervention, 1 month, and 3 months post-intervention), and material evaluation (immediately after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: A nudge-based web-based educational material on HPV vaccine-related disease prevention will be provided once to parents of adolescent boys.
Interventions/Control_2
Control group: A web-based information sheet on HPV-related disease prevention without intentional use of nudges will be provided once to parents of adolescent boys.
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
| 30 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Residents of areas that provide subsidies for HPV vaccination for adolescent boys
2.Parents aged 30-55 years who have a son born in fiscal years 2010-2014
Key exclusion criteria
1. Parents who have a son born before fiscal year 2009
2. Parents who have a daughter born before fiscal year 2014
3. Parents engaged in industries that may bias the survey (mass media, advertising, market research)
4.Parents whose son has already received HPV vaccination or whose vaccination status is unknown
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yukie |
| Middle name | |
| Last name | Kameda |
Organization
Ishikawa Prefectural Nursing University
Division name
Division of Maternal and Pediatric Nursing
Zip code
9291210
Address
Division of Maternal and Pediatric Nursing
TEL
+81-76-281-8379
ykameda@ishikawa-nu.ac.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Kameda |
Organization
Ishikawa Prefectural Nursing University
Division name
Division of Maternal and Pediatric Nursing
Zip code
9291210
Address
1-1 Gakuendai, Kahoku City, Ishikawa, Japan
TEL
+81-76-281-8379
Homepage URL
ykameda@ishikawa-nu.ac.jp
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Prefectural Nursing University Research Ethics Committee
Address
1-1 Gakuendai, Kahoku City, Ishikawa, Japan
Tel
+81-76-281-8300
office@ishikawa-nu.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
| 2026 | Year | 09 | Month | 07 | 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
| 2026 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2027 | Year | 04 | Month | 30 | Day |
Other
Other related information
This study is a randomized controlled trial to evaluate the effectiveness of the educational material, based on the acceptability and feasibility demonstrated in a preceding pre-post study (UMIN Trial ID: UMIN000061609). This study is supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant-in-Aid for Scientific Research (C) (Grant Numbers: 24K13930, 24K14116).
Management information
Registered date
| 2026 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071939
