UMIN-CTR Clinical Trial

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