UMIN-CTR Clinical Trial

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
Email	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
Email	hiroshi.yoshida.e2@tohoku.ac.jp

Sponsor
Institute	Graduate School of Economics and Management, Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051756