UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053016 |
|---|---|
| Receipt number | R000060475 |
| Scientific Title | Factors Promoting and Discouraging Lifestyle-related Disease Prevention Health Examinations among Dependent Women Raising Children |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/06 14:01:35 |
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Basic information
Public title
Research on health checkups for prevention of lifestyle-related diseases for women raising children
Acronym
Research on health checkups for prevention of lifestyle-related diseases for women raising children
Scientific Title
Factors Promoting and Discouraging Lifestyle-related Disease Prevention Health Examinations among Dependent Women Raising Children
Scientific Title:Acronym
Factors Promoting and Discouraging Lifestyle-related Disease Prevention Health Examinations among Dependent Women Raising Children
Region
| Japan |
Condition
Condition
adult woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and examine the effectiveness of an educational program to raise awareness of health checkups and specified health checkups, focusing on women in their 20s and 30s who are raising children, with the aim of increasing the percentage of dependent woman receiving specified health checkups.
Basic objectives2
Others
Basic objectives -Others
Changes in the health checkup uptake rate and awareness of specific health checkups
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of medical checkups received from before to after the start of the study
Key secondary outcomes
Health checkup awareness, interview analysis results, CFIR
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Women in their 20s to 30s living in the study area who are raising children and who do not have the opportunity to receive medical checkups at their workplaces.
Key exclusion criteria
Nothing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Tokyo Medical and Dental University
Division name
Department of Public Health Nursing
Zip code
1138519
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5350
rumitsukinoki@gmail.com
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Tokyo Medical and Dental University
Division name
Department of Public Health Nursing
Zip code
1138519
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5350
Homepage URL
rumitsukinoki@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
ministry of education, culture, sports, science and
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
Bioethics Research Center
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
Tel
03-5803-5350
rumitsukinoki@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
| 2023 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research method will be a project targeting "health checkups from age 20 (medical checkups)" (ward residents aged 20-39) in Ward A, Tokyo. This project has been launched in Ward A since FY2016; however, active awareness-raising activities and reviews, such as awareness-raising in conjunction with maternal and child health care programs, have not yet been conducted. This study will develop and implement an awareness-raising activity to improve health checkup uptake and specific health checkup awareness of the "health checkup from age 20" focusing on women raising children (mainly dependents). The study design is a mixed-method research using the RE-AIM model (regional intervention study: one group before and after comparison. The main outcome will be changes in the health checkup uptake rate and awareness of specific health checkups from the age of 20, and qualitative research will be conducted by interviewing local governments and related organizations using CFIR).
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060475
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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