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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027716
Receipt No. 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

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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
Email 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
Email hidaka@int.oksaka-sandai.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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