UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045320 |
|---|---|
| Receipt number | R000051756 |
| Scientific Title | Effects of Self-Monitoring with Smart Bands on Health and Health Awareness of College Students |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/09/18 22:05:27 |
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Basic information
Public title
Effects of Self-Monitoring with Smart Bands on Health and Health Awareness of College Students
Acronym
Effectiveness of self-monitoring behaviour using smart bands
Scientific Title
Effects of Self-Monitoring with Smart Bands on Health and Health Awareness of College Students
Scientific Title:Acronym
Effectiveness of self-monitoring behaviour using smart bands
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the impact of self-monitoring activities using a smart band on the health and health consciousness of college students.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of self-monitoring behaviour on the number of steps taken per day by participants within one month of the start of the experiment.
Key secondary outcomes
Changes in sleeping hours and lifestyle habits (from questionnaire survey)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Daily reporting of established health indicators
Interventions/Control_2
No daily reporting of established health indicators
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy individuals
(2) Males between 20 and 30 years of age
(3) Those who have given written and oral consent to the detailed explanation of the study
Key exclusion criteria
(1) Those who have contact dermatitis
(2) Those with movement disorders
(3) Those who find it undesirable to wear electronic devices
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University
Division name
Graduate School of Economics and Management
Zip code
980-8576
Address
27-1,Kawauchi, Aobaku, Sendai
TEL
022-795-6292
hiroshi.yoshida.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University
Division name
Graduate School of Economics and Management
Zip code
980-8576
Address
27-1,Kawauchi,Aobaku, Sendai
TEL
022-795-6292
Homepage URL
hiroshi.yoshida.e2@tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Economics and Management, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency, COI Tohoku Site
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Economics and Management, Tohoku University
Address
27-1,Kawauchi, Aobaku, Senndai
Tel
022-795-6292
hiroshi.yoshida.e2@tohoku.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 | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.econ.tohoku.ac.jp/publications/terg
Number of participants that the trial has enrolled
50
Results
It was confirmed that self-monitoring, in the form of reporting health indicators, did not affect the lifestyle habits of college students but did lead to an increase in the average number of daily steps taken. However, this effect was confirmed only in the first half of the study.
Results date posted
| 2022 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051756
