UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058728 |
|---|---|
| Receipt number | R000067144 |
| Scientific Title | Effect of AI Advisory on Step Count Increase: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 16:11:30 |
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Basic information
Public title
Effect of AI Advisory on Step Count Increase: A Randomized Controlled Trial
Acronym
Effect of AI Advisory on Step Count Increase Trial
Scientific Title
Effect of AI Advisory on Step Count Increase: A Randomized Controlled Trial
Scientific Title:Acronym
AI-RAC Trial
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The World Health Organization (WHO) recommends that adults engage in physical activity in its guidelines on physical activity and sedentary behavior. Physical activity is associated with various health benefits, including reduced all-cause and cardiovascular mortality, prevention of hypertension, site-specific cancers, and type 2 diabetes, as well as improvements in mental health. Similarly, the Japanese Ministry of Health, Labour and Welfare emphasizes the importance of physical activity in its 2023 Physical Activity and Exercise Guidelines for Health Promotion, recommending that adults aim to walk approximately 8,000 steps per day.
In recent years, mobile applications have gained attention as tools to promote behavioral change necessary to increase physical activity in daily life. Furthermore, with rapid advancements in artificial intelligence (AI) technologies, some applications have demonstrated improved health outcomes by providing personalized advice based on AI models. Although some of these applications have been implemented in Japan, limited data are available regarding their effectiveness in increasing step counts.
The aim of this study is to evaluate the effectiveness of AI-generated advice delivered via a mobile application in increasing daily step counts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in Step Counts Between the AI Advisory Group and the Control Group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
An application equipped with an AI advisory function
Interventions/Control_2
An application equipped without an AI advisory function
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Written informed consent will be obtained from each participant after providing a thorough explanation of the study and ensuring full understanding and voluntary agreement.
2.Participants must be aged 22 years or older and younger than 65 years at the time of consent.
3.Participants must be able to read Japanese.
4.Participants must be able to walk more than 10 steps without using a cane, walker, or wheelchair.
5.Participants must own a device compatible with the iOS operating system.
Key exclusion criteria
1.Individuals whose physical activity has been restricted by a physician will be excluded from the study.
2.Those who have experienced a myocardial infarction or stroke within the past six months will also be excluded.
3.Individuals with a systolic blood pressure of 180 mmHg or higher, or a diastolic blood pressure of 110 mmHg or higher, will not be eligible to participate.
4.Pregnant individuals, as well as those who plan to become pregnant during the study period, will be excluded.
5.In addition, individuals who are deemed unsuitable for participation by the principal investigator or co-investigators for any reason will not be included in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Osugi |
Organization
Fujita Health University
Division name
Community Based Medicine
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
0562932000
yosugi77@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Yamashita |
Organization
Rakuten Group Inc
Division name
Department of Healthcare
Zip code
1580094
Address
1 Chome-14-1 Tamagawa, Setagaya City, Tokyo, JAPAN
TEL
050-5581-6910
Homepage URL
yuya.a.yamashita@rakuten.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Rakuten Group Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2025 | Year | 08 | Month | 07 | 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
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067144
