UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027716 |
|---|---|
| Receipt number | R000030879 |
| Scientific Title | A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data. |
| Date of disclosure of the study information | 2017/06/11 |
| Last modified on | 2018/01/29 17:08:34 |
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Basic information
Public title
A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data.
Acronym
A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data.
Scientific Title
A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data.
Scientific Title:Acronym
A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data.
Region
| Japan |
Condition
Condition
Healthy first-year medical college students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine relationships between physical activity data measured by using wristband activity trackers, and psychological indices/lifestyle habits, and to increase personal health awareness among new medical students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes, assessed over 2weeks and measured by a wristband activity tracker, in physical exercise and sleep (amount of exercise, exercise time, calories burned, heart rate, and sleep time).
Key secondary outcomes
1.Height
2.Weight
3.POMS2:Profile of Mood States 2nd Edition
4.Questionnaire on lifestyle habits
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Examination of relationships between data of physical activity, tracked for 2weeks wearing physical activity tracker, and POMS2 results. In addition, examination of changes in awareness of lifestyle habits, in continuous physical activity indices, and in weight.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those registered as first-year students on April 1st, 2017
2.Those able to understand the content of the device/test of this study and operate the technology involved in the study
3.Those who have provided written, informed consent to participate in the study upon full understanding after adequate explanation of the study has been provided
Key exclusion criteria
1.Those finding self-directed physical activity to be difficult
2.Those with allergic reactions to the rubber in the wristband
3.Those judged by investigators to be unsuitable for study participation for reasons other than the above
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kimura |
Organization
Kansai Medical University
Division name
Health Science
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
TEL
072-804-0101
kimuray@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagisa Hidaka |
Organization
Osaka Sangyo University
Division name
Faculty of International Studies
Zip code
Address
3-1-1 Nakagaito, Daito City, Osaka 574-8530 Japan
TEL
072-875-3001
Homepage URL
hidaka@int.oksaka-sandai.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030879
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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