UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054050 |
|---|---|
| Receipt number | R000061707 |
| Scientific Title | Impact of presentation of genome analysis results on behavioral change for prevention of lifestyle-related diseases: exploratory study |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/10/05 10:34:14 |
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Basic information
Public title
Impact of presentation of genome analysis results on behavioral change for prevention of lifestyle-related diseases: exploratory study
Acronym
Impact of presentation of genome analysis results on behavioral change for prevention of lifestyle-related diseases: exploratory study
Scientific Title
Impact of presentation of genome analysis results on behavioral change for prevention of lifestyle-related diseases: exploratory study
Scientific Title:Acronym
Impact of presentation of genome analysis results on behavioral change for prevention of lifestyle-related diseases: exploratory study
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of presentation of genomic analysis results on behavioral change for prevention of lifestyle-related diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in change of number of steps, diet, exercise, and body composition with and without presentation of genomic analysis results
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
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pre-group: group that presents genome analysis results
Interventions/Control_2
Post-group: No genome analysis results presented
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees of Matsushita Memorial Hospital who will receive medical examinations between April 1, 2024 and March 31, 2025 and who wish to participate in this study.
People who have access to their own smartphones.
Key exclusion criteria
People who need acute care for malignant disease, heart disease, etc.
People who are pregnant.
People whom the researcher considered inappropriate for the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Hashimoto |
Organization
Matsushita Memorial Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
570-8540
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
TEL
06-6992-1231
y-hashi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Hashimoto |
Organization
Matsushita Memorial Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
570-8540
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
TEL
06-6992-1231
Homepage URL
y-hashi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Matsushita Memorial Hospital
Institute
Department
Personal name
Yoshitaka Hashimoto
Funding Source
Organization
Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Zene inc., Healthtech Laboratory, Inc.
Name of secondary funder(s)
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science
IRB Contact (For public release)
Organization
Matsushita Memorial Hospital
Address
5-55 Sotojima-cho, Moriguchi 570-8540, Japan
Tel
06-6992-1231
sugimoto.mayumi@jp.panasonic.com
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 | 03 | Month | 31 | 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
224
Results
Among the participants, 154 individuals (74 in the results-presentation group and 79 in the non-results-presentation group) were included in the analysis for the step count. The results-presentation group showed a statistically significant increase of 932 steps compared to the non-results-presentation group. Furthermore, the results-presentation intervention was associated with an increase in step count (920 steps) even after adjusting for various factors.
Results date posted
| 2025 | Year | 10 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It is taking time to compile the data.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Primary outcome measure: Change in step count
Secondary outcome measures: Changes in body composition and dietary habits
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061707
