UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063421 |
|---|---|
| Receipt number | R000071630 |
| Scientific Title | Heterogeneity in the effects of a step-count intervention: a randomized controlled trial |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/26 15:56:13 |
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Basic information
Public title
Heterogeneity in the effects of a step-count intervention: a randomized controlled trial
Acronym
Heterogeneity in the effects of a step-count intervention: a randomized controlled trial
Scientific Title
Heterogeneity in the effects of a step-count intervention: a randomized controlled trial
Scientific Title:Acronym
Heterogeneity in the effects of a step-count intervention: a randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy adults in the community
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the heterogeneity in the effects of two different step-count recommendations on changes in daily step counts among adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heterogeneous intervention effects on changes in daily step counts from baseline to 1 month according to baseline characteristics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recommendation to achieve 8,000 steps per day
Interventions/Control_2
Recommendation to increase daily steps by 1,000 steps
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 20 years or older
2) Participants in the Lifestyle Awareness Survey by Rakuten Insight's
3) Self-reported an average of at least 2,000 steps per day in the screening survey
4) Regular iPhone users willing to continue use during the study
5) Able to provide iPhone Health app step-count screenshots
6) Able to complete web-based surveys in Japanese and provide informed consent
Key exclusion criteria
1) Individuals with pain or disease limiting daily walking or physical activity
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Inoue |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Health Promotion and Behavioral Sciences
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
inoue.kosuke.2j@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Amagasa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Health Promotion and Behavioral Sciences
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
Homepage URL
amagasa.shiho.oa@teikyo-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071630
