UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037681 |
|---|---|
| Receipt number | R000040350 |
| Scientific Title | Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age |
| Date of disclosure of the study information | 2019/08/14 |
| Last modified on | 2019/11/11 14:53:30 |
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Basic information
Public title
Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Acronym
Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Scientific Title
Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Scientific Title:Acronym
Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Region
| Japan |
Condition
Condition
health education program to educate preconception care (PCC) for female workers of reproductive age
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to implement a health education program to educate preconception care (PCC) for female workers of reproductive age to evaluate the program based on knowledge, awareness and behaviors regarding PCC before, after and 3,6 months after the seminars.
Basic objectives2
Others
Basic objectives -Others
indicators were feeling of self-efficacy; health awareness, based on the health promotion lifestyle profile scale; and stress management. (before, after and 3,6 months after the seminars.)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome indicators were knowledge of PCC; consciousness and behaviors related to PCC; nutrient intake amounts, based on food intake frequency survey.
before, after and 3,6 months after the seminars.
Key secondary outcomes
Sub-outcome indicators were feeling of self-efficacy; health awareness, based on the health promotion lifestyle profile scale; and stress management.
before, after and 3,6 months after the seminars.
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
| Behavior,custom |
Interventions/Control_1
one health education seminars and one group discussions in small groups using leaflets, and three feedback in the form of comments were provided to the participants.(after and 3 months after the seminars.)
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
female workers of reproductive age, aged 20 to 35 years.
Key exclusion criteria
The person who engaged in pregnant person, physician, dentist, pharmacist, community health nurse, nurse midwife, nurse, work of the dietitian excluded it.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Sasaki |
Organization
Osaka Medical College
Division name
The Faculty of Nursing
Zip code
569-0095
Address
7-6 Hattyonishi-machi, Takatsuki-City, osaka, Japan
TEL
072-684-7033
ayabe@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Sasaki |
Organization
Osaka Medical College
Division name
The Faculty of Nursing
Zip code
569-0095
Address
7-6 Hattyonishi-machi, Takatsuki-City, osaka, Japan
TEL
072-684-7033
Homepage URL
ayabe@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
no
Name of secondary funder(s)
Setsunan University
IRB Contact (For public release)
Organization
Osaka Medical College study Ethical Review Board
Address
2-7, Daigakumachi, Takatsuki-shi, Osaka
Tel
072-683-1221
rinri@osaka-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2018-032
Org. issuing International ID_1
Setsunan university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 14 | 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
84
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
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040350
