UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050058 |
|---|---|
| Receipt number | R000057028 |
| Scientific Title | Development of a Preemptive Health Intervention Model for Disease Prevention |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2025/01/23 12:41:57 |
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Basic information
Public title
Development of a Preemptive Health Intervention Model for Disease Prevention
Acronym
Development of a Preemptive Health Intervention Model
Scientific Title
Development of a Preemptive Health Intervention Model for Disease Prevention
Scientific Title:Acronym
Development of a Preemptive Health Intervention Model
Region
| Japan |
Condition
Condition
Hypertension, diabetes, dyslipidemia, etc.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the factors associated with various health conditions, such as exercise, nutrition, sleep, stress, oral health, and living conditions, and to construct a prediction model for disease onset by synthesizing the findings. We propose a tool that can be utilized to implement proactive health interventions to prevent the onset of disease.
Basic objectives2
Others
Basic objectives -Others
Development of predictive models for disease onset
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of metabolic disorders such as hypertension, diabetes mellitus, dyslipidemia, and others.
Key secondary outcomes
Medical consultation
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The following measurement devices and applications are used to measure each health and living condition.
Exercise: fitbit, step counting application
Nutritional status: Salt check sheet, Calomama Plus
Sleep state: fitbit, brain sleep coin
Stress state: fitbit
Oral condition: saliva
Lifestyle condition: Calomama Plus
Room temperature: thermometer
Other health conditions: fundus image
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Citizens in municipalities participating in the LIFE Study
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruhisa |
| Middle name | |
| Last name | Fukuda |
Organization
Kyushu University
Division name
Graduate School of Medical Sciences
Zip code
812-8582
Address
Maidashi 3-1-1 Higashi-ku Fukuoka
TEL
0926426960
hal.fukuda@gmail.com
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Fukuda |
Organization
Kyushu University
Division name
Graduate School of Medical Sciences
Zip code
812-8582
Address
Maidashi 3-1-1 Higashi-ku Fukuoka
TEL
0926426956
Homepage URL
hal.fukuda@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Haruhisa Fukuda
Funding Source
Organization
AMED
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
Kyushu University Hospital Ethics Review Committee
Address
Maidashi 3-1-1 Higashi-ku Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2023 | Year | 01 | Month | 17 | 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
20429
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057028
