UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047988 |
|---|---|
| Receipt number | R000054704 |
| Scientific Title | Evaluation of leaflets and DVDs for preconception care awareness for adolescent women |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2025/01/29 11:29:16 |
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Basic information
Public title
Evaluation of leaflets and DVDs for preconception care awareness for adolescent women
Acronym
Evaluation of leaflets and DVDs for preconception care awareness for adolescent women
Scientific Title
Evaluation of leaflets and DVDs for preconception care awareness for adolescent women
Scientific Title:Acronym
Evaluation of leaflets and DVDs for preconception care awareness for adolescent women
Region
| Japan |
Condition
Condition
Adolescent women
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In 2018, a health education program was implemented and evaluated for preconception care (PCC) awareness among mature working females in Japan. The present study aimed to conduct and evaluate a health education seminar for PCC awareness among adolescent females in Japan using leaflet and newly created video, which were improved based on the 2018 evaluation.
Basic objectives2
Others
Basic objectives -Others
In 2018, a health education program was implemented and evaluated for preconception care (PCC) awareness among mature working females in Japan. The present study aimed to conduct and evaluate a health education seminar for PCC awareness among adolescent females in Japan using leaflet and newly created video, which were improved based on the 2018 evaluation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge of PCC(Before / immediately after the seminar and 6 months later)
Awareness and behavior related to PCC(Before the seminar and 6 months later)
Key secondary outcomes
Health Promotion Lifestyle Profile Scale
Before the seminar and 6 months later
About the clarity of leaflets and DVDs
Before the seminar
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A 30-minute seminar will be held using leaflets and DVDs to raise awareness of preconception care.
Interventions/Control_2
Do not hold a 30-minute seminar using leaflets and DVDs for preconception care awareness
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Adolescent women between the ages of 18 and 25
Key exclusion criteria
Pregnant adolescent women between the ages of 18 and 25
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Nagusa |
Organization
Setsunan University
Division name
faculty of nursing
Zip code
573-0101
Address
45-1 Nagaotoge-cho,Hirakata City,Osaka
TEL
072-800-1069
m-nagusa@nrs.setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Nagusa |
Organization
Setsunan University
Division name
faculty of nursing
Zip code
573-0101
Address
45-1 Nagaotoge-cho,Hirakata City,Osaka
TEL
072-800-1069
Homepage URL
m-nagusa@nrs.setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Setsunan University Research Ethics Review Board for Humans
Address
17-8 Ikeda-nakamachi,Neyagawa City Osaka,572-8508,Japan
Tel
072-800-1160
SETSUNAN.Kenkyu.Shakai@josho.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20K19196
Org. issuing International ID_1
Japan Science and Technology Agency
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
119
Results
Immediately after the seminar, the number of participants who answered "correct" to seven of the nine "PCC knowledge" questions among the 67 participants in the intervention group increased. For the five questions the number of participants who answered "correct" decreased six months after the seminar. For the 52 participants in the control group, the number of participants who answered "correct" to eight of the nine "PCC knowledge" questions did not change.
Results date posted
| 2024 | Year | 06 | Month | 10 | Day |
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
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 12 | 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
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054704
