UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of relationships between physical activity and psychological indices by secondary use of continuous longitudinal physical activity data.
Title of the study (Brief title)	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	Yutaka Kimura
Organization	Kansai Medical University
Division name	Health Science
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	Nagisa Hidaka
Organization	Osaka Sangyo University
Division name	Faculty of International Studies
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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