UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048913 |
|---|---|
| Receipt number | R000055733 |
| Scientific Title | Validation of an Intervention Program for Preconception Health Knowledge and Behavior Based on Behavior Change Theory for Preconception Women |
| Date of disclosure of the study information | 2022/09/13 |
| Last modified on | 2023/05/09 10:23:34 |
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Basic information
Public title
Validation of an Intervention Program for Preconception Health Knowledge and Behavior Based on Behavior Change Theory for Preconception Women
Acronym
Validation of an Intervention Program for Preconception Health Knowledge and Behavior Based on Behavior Change Theory for Preconception Women
Scientific Title
Validation of an Intervention Program for Preconception Health Knowledge and Behavior Based on Behavior Change Theory for Preconception Women
Scientific Title:Acronym
Validation of an Intervention Program for Preconception Health Knowledge and Behavior Based on Behavior Change Theory for Preconception Women
Region
| Japan | Asia(except Japan) |
Condition
Condition
Preconception Women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility of the proposed intervention package on proper nutrition and diet in feasibility studies in universities and companies. Using the developed intervention package, the intervention will be implemented and the feasibility and effectiveness of the intervention will be evaluated by analyzing changes in the preconception care health literacy scale before and after the intervention, changes in intention to improve lifestyle immediately after the intervention, and changes in lifestyle improvement one month after the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of items that changed in the direction of improvement on the preconception care health literacy scale (behaviors and skills) at 1 month post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Video lecture
Interventions/Control_2
no trearment
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
The following criteria will be applied to all persons who meet all of the following criteria
1) Women between the ages of 20 and 39 at the time consent is obtained
2) No prior history of childbirth
3) Persons who have given their written consent to participate in this study.
Key exclusion criteria
Persons who violate any of the following will not be included in this research
1) Persons deemed inappropriate by the principal investigator (co-investigator)
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Ota |
Organization
St. Luke's international university
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0335436391
ota@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
St. Luke's international university
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0335436391
Homepage URL
21dn007@slcn.ac.jp
Sponsor or person
Institute
Ministory of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministory of Health, Labour and Welfare
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
St. Luke's international university
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
Tel
0335436391
21dn007@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
| 2022 | Year | 09 | Month | 13 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2023 | 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 | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055733
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
