UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045308 |
|---|---|
| Receipt number | R000051550 |
| Scientific Title | Cross-sectional study for building a health information database by the survey of the regional characteristics: Based on health information, food-oriented lifestyle and neighborhood environment in the community. |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/05/13 15:19:27 |
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Basic information
Public title
Cross-sectional study for building a health information database by the survey of the regional characteristics: Based on health information, food-oriented lifestyle and neighborhood environment in the community.
Acronym
Research for healthy community development in Tsuno Town
Scientific Title
Cross-sectional study for building a health information database by the survey of the regional characteristics: Based on health information, food-oriented lifestyle and neighborhood environment in the community.
Scientific Title:Acronym
Cross-sectional study for building a health information database by the survey of the regional characteristics: Based on health information, food-oriented lifestyle and neighborhood environment in the community.
Region
| Japan |
Condition
Condition
Residents of Tsuno Town, Miyazaki, Japan
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between dietary habit, physical activity, lifestyle, neighborhood environment and health.
Basic objectives2
Others
Basic objectives -Others
Clarify the regional characteristic data and build a database using the relevant data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of lifestyle, neighborhood environment and health (visceral fat, lifestyle-related diseases, etc.).
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Residents of Tsuno town.
2.Subjects who have received or are scheduled to undergo a health checkup in the same year or the same fiscal year of this survey and can agree to provide the results of the health checkup.
3.In the case that the results of the health checkup are managed by Tsuno town, subjects who can agree to use the data through the Tsuno town health management center.
4.Subjects who can answer the questionnaire voluntarily. 5.Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation of this study.
Key exclusion criteria
1.Subjects who are found to have an illness that requires emergency response on the day of this survey.
2.Subjects who have been in close contact with or are suspected of having novel coronavirus infection and are prohibited from going out on the day of this survey.
3. Subjects who have cognitive disorder or who have possibility of the disorder that make it difficult to complete the questionnaire.
4.Subjects who are pregnant.
5.Subjects who are drug dependence, subjects who are suspected of drug dependence.
6.Subjects who don't plan to undergo a health checkup in the year of study enrollment and wish to participate in this study only.
7.Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department of the University Hospital's Kiyotake Satellite Branch, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department, University of Miyazaki
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Tsuno town, Miyazaki Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.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
| 2021 | Year | 09 | Month | 01 | 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
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
-Cross-sectional study.
-From September 9, 2021 to December 31, 2022, we will be recruiting a wide range of eligible participants in Tsuno Town, Miyazaki Prefecture.
-Items to be measured: Basic information of the subjects (gender, age, address), questionnaire (basic information, smoking status, physical activity, sleep status, quality of life (SF-8), stress, walkability (ANEWS), dietary intake (FFQ), etc.), body measurements (height, weight, BMI, abdominal circumference), visceral fat area, body composition (muscle mass, extremity skeletal muscle mass, skeletal muscle mass index, fat mass, body fat percentage), grip strength, AGEs, health examination results (blood pressure, blood and urine test results).
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051550
