UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048388 |
|---|---|
| Receipt number | R000055156 |
| Scientific Title | A Study for Feasibility and Social Implementation of Intervention Methods for Nutrition and Health Management for Preconception Women in a Municipality (Yamato City) |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2023/04/06 11:20:02 |
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Basic information
Public title
A Study for Feasibility and Social Implementation of Intervention Methods for Nutrition and Health Management for Preconception Women in a Municipality (Yamato City)
Acronym
A Study for Feasibility and Social Implementation of Intervention Methods for Nutrition and Health Management for Preconception Women in a Municipality (Yamato City)
Scientific Title
A Study for Feasibility and Social Implementation of Intervention Methods for Nutrition and Health Management for Preconception Women in a Municipality (Yamato City)
Scientific Title:Acronym
A Study for Feasibility and Social Implementation of Intervention Methods for Nutrition and Health Management for Preconception Women in a Municipality (Yamato City)
Region
| Japan |
Condition
Condition
Preconception women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of the proposed intervention package on appropriate nutrition and eating behavior in a small feasibility study at the municipal level. Verifying the feasibility of the intervention package at the municipal level will lead to social implementation of preconception care and sustainable care provision. It is expected to improve the health literacy of young women in the community, encourage lifestyle changes, and improve their health.
Basic objectives2
Others
Basic objectives -Others
Behavior change
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Acceptability
- Demand
- Feasibility
- Practicality
- Adaptability
- Areas of limited program effectiveness
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
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
Preconception care counceling at health checkups
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Women between the ages of 18 and 35
2) Those who have no history of delivery
3) Women who have agreed to participate in the study among those who will receive health checkups for women in Yamato City.
Key exclusion criteria
1) Those who are unable to receive health examinations for women in Yamato City for any reason.
2) Others whom the principal investigator (research collaborator) deems inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Arata |
Organization
National center for child health and development
Division name
Division of Maternal Medicine, Center for Maternal-Fetal, Neonatal, and Reproductive Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
boseinaika@gmail.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
National center for child health and development
Division name
Division of Maternal Medicine, Center for Maternal-Fetal, Neonatal, and Reproductive Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
boseinaika@gmail.com
Sponsor or person
Institute
Ministry of Health, Labor and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor 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
National center for child health and development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
boseinaika@gmail.com
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 | 07 | Month | 15 | 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 | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055156
