UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043746 |
|---|---|
| Receipt number | R000049911 |
| Scientific Title | Evaluating the Effects of Artificial Intelligence-Aided Health Guidance on Personal Health Promotion: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2021/05/21 16:56:55 |
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Basic information
Public title
Evaluating the Effects of Artificial Intelligence-Aided Health Guidance on Personal Health Promotion: A Randomized Controlled Trial
Acronym
Evaluating the Effects of Artificial Intelligence-Aided Health Guidance on Personal Health Promotion
Scientific Title
Evaluating the Effects of Artificial Intelligence-Aided Health Guidance on Personal Health Promotion: A Randomized Controlled Trial
Scientific Title:Acronym
Evaluating the Effects of Artificial Intelligence-Aided Health Guidance on Personal Health Promotion
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarifies whether health guidance based on health prediction using artificial intelligence is more effective than the existing health guidance process in improving the individuals' health through a randomized controlled trial among health checkup recipients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in body mass index (BMI) values between the intervention year and the following year for each group.
Key secondary outcomes
Mean change in the following parameters between the intervention year and the following year for each group:
Weight, abdominal circumference, blood pressure (systolic, diastolic), liver function (AST, ALT, GTP), lipids (triglycerides, LDL/HDL cholesterol), blood glucose (fasting blood glucose, HbA1c), renal function (creatinine, eGFR), uric acid level, each questionnaire in the physical examination, and questions to be prepared for the study.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health guidance will be provided using an AI-based health prediction results table, which will highlight items requiring improvement.
Interventions/Control_2
Health guidance will be provided using the normal results table that is usually used in health guidance (not by AI-based results).
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
| 16 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Examinees who undergo health-checkups at Yamanashi Koseiren Health Care Center from April 1, 2021, to March 31, 2023, and meet the following conditions.
(1) Received a health-checkup at the same facility in the previous year.
(2) Body mass index (BMI) at the time of examination in the previous year was 22 or higher.
(3) The age at the time of health-checkup is 74 years or younger.
(4) Patients who answered that they do not have regular hospital visits.
(5) Patients who give written consent for participation in this study.
(Registrations from April 1, 2022 to March 31, 2023 is limited to the situation where the required number of cases could not be collected in the fiscal year 2021.)
Key exclusion criteria
The exclusion criteria include:
(1) Participants under 16 years of age.
(2) Patients unable to receive health guidance by staff due to physical, mental, or other reasons or who are expected to be constrained in the quality of health guidance.
Target sample size
2720
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Ooka |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Health Sciences
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
0552739566
tohoka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Ooka |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Health Sciences
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
0552739566
Homepage URL
tohoka@yamanashi.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Faculty of Medicine, University of Yamanashi.
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamanashi Koseiren Health Care Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Health Sciences, Faculty of Medicine, University of Yamanashi.
Address
1110, Shimokato, Chuo, Yamanashi, Japan
Tel
0552739566
tohoka@yamanashi.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 | 03 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
