UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045310 |
|---|---|
| Receipt number | R000051749 |
| Scientific Title | Development and Validation of Self-Monitoring as a Preventive Measure for Lifestyle-related Diseases |
| Date of disclosure of the study information | 2021/08/30 |
| Last modified on | 2025/09/30 11:41:09 |
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Basic information
Public title
Development and Validation of Self-Monitoring as a Preventive Measure for Lifestyle-related Diseases
Acronym
Self-Monitoring as a Preventive Measure for Lifestyle-related Diseases
Scientific Title
Development and Validation of Self-Monitoring as a Preventive Measure for Lifestyle-related Diseases
Scientific Title:Acronym
Self-Monitoring as a Preventive Measure for Lifestyle-related Diseases
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to verify the effect of positive behavior support self-monitoring as a preventive measure against lifestyle-related diseases, and its role to improve health literacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Literacy
Adherence
Key secondary outcomes
Blood test (Triglycerides, High-density lipoprotein cholesterol, Fasting plasma glucose)
Waist circumference
Body Composition
Systolic blood pressure
Diastolic blood pressure
Visceral fat
Skin carotenoid
Salivary test
Physical function (Hand-grip strength, stand-up test, two-step test)
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
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: positive behavior support group
Interventions/Control_2
Control group 1: motivation support group
Interventions/Control_3
Control group 2: Self-management group
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. Participation in the health promotion program
2. Agreement with the research content
Key exclusion criteria
1. Participants of Specific health guidance
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | MIKAMI |
Organization
Hirosaki University
Division name
Innovation Center for Health Promotion
Zip code
0368562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5037
tmika@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | SAWADA |
Organization
Hirosaki University
Division name
Innovation Center for Health Promotion
Zip code
0368562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5450
Homepage URL
iwane@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics committee of Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5043
rinri@hirosaki-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 | 08 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/pmr/1/4/1_23008/_pdf/-char/en
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
597
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Publication completed, currently undergoing peer review
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
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051749
