UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043746
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tohoka@yamanashi.ac.jp

Sponsor
Institute Department of Health Sciences, Faculty of Medicine, University of Yamanashi.
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


Contact us.