UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061734 |
|---|---|
| Receipt number | R000070654 |
| Scientific Title | Effects of Implementing the 4th-Period Specific Health Checkups and Specific Health Guidance in the Post-Pandemic Era on Participants' Lifestyle Modifications and Specific Health Checkup Outcomes in the Following Year |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/29 14:52:07 |
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Basic information
Public title
Effects of Implementing the 4th-Period Specific Health Checkups and Specific Health Guidance in the Post-Pandemic Era on Participants' Lifestyle Modifications and Specific Health Checkup Outcomes in the Following Year
Acronym
Effects of Implementing the 4th-Period Specific Health Checkups and Specific Health Guidance in the Post-Pandemic Era on Participants' Lifestyle Modifications and Specific Health Checkup Outcomes in the Following Year
Scientific Title
Effects of Implementing the 4th-Period Specific Health Checkups and Specific Health Guidance in the Post-Pandemic Era on Participants' Lifestyle Modifications and Specific Health Checkup Outcomes in the Following Year
Scientific Title:Acronym
Effects of Implementing the 4th-Period Specific Health Checkups and Specific Health Guidance in the Post-Pandemic Era on Participants' Lifestyle Modifications and Specific Health Checkup Outcomes in the Following Year
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the baseline characteristics, including awareness of lifestyle habits and stages of behavioral change, by comparing participants who completed Specific Health Guidance with those who dropped out.
Basic objectives2
Others
Basic objectives -Others
By comparing the data at the time of implementation with Specific Health Checkup results in the following year (body weight, abdominal circumference, and blood tests), we aim to identify the characteristics of participants who achieved significant improvements. Through these analyses, this study seeks to provide insights that contribute to improving the participation rate and quality of Specific Health Guidance.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Specific Health Guidance data will be collected for the period from the initial consultation to the end of the intervention.
Key secondary outcomes
1) Specific Health Guidance Data
guidance category (Motivational Support, Active Support, or Motivational Support Equivalent), healthcare practitioner type (Public Health Nurse or Registered Dietitian), stage of behavioral change, target-setting categories, goal achievement status
Height, body weight, body mass index (BMI), abdominal circumference, blood pressure, blood glucose, HbA1c, triglycerides, total cholesterol, LDL-c, HDL-c, AST, ALT, BUN, eGFR, Cre, UA, ganma-GTP, non-HDL, and ALP.
2) Health Checkup Data
WBC, RBC, Hb, Ht, MCV, MCHC, Plt, Alb, Na, K, Ca, urinary glucose, and urinary protein.
Lifestyle and Questionnaire Variables: comorbidities, exercise habits, sleep, stress, weight gain rate since age 20, walking speed, and sedentary time.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All individuals who are eligible for Specific Health Guidance in the relevant fiscal year will be included as study participants.
Key exclusion criteria
- Individuals who were eligible for Specific Health Guidance but refused to participate in the initial consultation.
- Individuals who declined to participate in this study (those who submitted a refusal form via the designated online form after the opt-out notice was displayed at the collaborating research institution).
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Yasueda |
Organization
Otemae University
Division name
Faculty of Health and Nutrition
Zip code
5400008
Address
2-1-88 Otemae,Chuo-ku, Osaka-shi
TEL
+81-6-6941-7698
yasueda@otemae.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Yasueda |
Organization
Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name
Division of Specific Health Guidance
Zip code
536-8588
Address
1-6-107, Morinomiya, Jyoto-ku, Osaka-shi
TEL
+81-6-6969-6711
Homepage URL
a-yasueda@osaka-ganjun.jp
Sponsor or person
Institute
Otemae University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otemae University
Address
2-1-88 Otemae,Chuo-ku, Osaka-shi
Tel
+81-6-6941-7698
yasueda@otemae.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
大阪がん循環器病予防センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070654
