UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059203 |
|---|---|
| Receipt number | R000067709 |
| Scientific Title | Verification of retention rates for healthy adults in mindfulness seminars |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/09/26 14:47:55 |
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Basic information
Public title
Verification of retention rates in mindfulness seminars
Acronym
Verification of retention rates in mindfulness seminars
Scientific Title
Verification of retention rates for healthy adults in mindfulness seminars
Scientific Title:Acronym
Verification of retention rates for healthy adults in mindfulness seminars
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the retention rate of a newly developed mindfulness seminars
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seminar retention rate
Meditation practice status
Key secondary outcomes
Amount of change in sleep efficiency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
6-week Mindfulness Program (including online seminars, audio guides, and Fitbit integration)
Interventions/Control_2
Waitlist control group (receives the same recorded seminar after the intervention group, with Fitbit integration)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy men and women aged 20 years or older at the time of obtaining informed consent
2.Individuals enrolled in the NTT Health Insurance Association
3.Individuals with a properly functioning connection to the Fitbit app
4.Individuals who can consent to data acquisition through the use of Fitbit API integration
5.Individuals who can participate in seminars and questionnaires conducted during the research period
Key exclusion criteria
1. Individuals who are not currently using Fitbit and are not expected to use it in the future
2. Individuals who have experienced discomfort during previous meditation sessions or similar activities
3. Individuals who have experienced skin diseases due to wearing Fitbit
4. Individuals who received treatment for mental or sleep disorders at a psychosomatic medicine department in the past two years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | satomi |
| Middle name | |
| Last name | kawakami |
Organization
NTT health insurance union
Division name
Headquarters
Zip code
101-0047
Address
17F Urbannet Kanda Building, 3-6-2 Uchikanda, Chiyoda, Tokyo, Japan
TEL
03-6206-4041
satomi.kawakami.tf@ntt-ba.co.jp
Public contact
Name of contact person
| 1st name | satomi |
| Middle name | |
| Last name | kawakami |
Organization
NTT health insurance union
Division name
Headquarters
Zip code
101-0047
Address
17F Urbannet Kanda Building, 3-6-2 Uchikanda, Chiyoda, Tokyo, Japan
TEL
03-6206-4041
Homepage URL
satomi.kawakami.tf@ntt-ba.co.jp
Sponsor or person
Institute
NTT health insurance union
Institute
Department
Personal name
Funding Source
Organization
NTT health insurance union
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic Institutional review board
Address
5F,Inamura Building,1-9-2,Nihonbashikayabacho,Chuo-ku,, Tokyo,Japan
Tel
03-6661-9061
c-irb_ug@neues.co.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 | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 25 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067709
