UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015483
Receipt number R000017981
Scientific Title Developing Health Promotion Program based on Wearable ICT and Collective Responsibility
Date of disclosure of the study information 2014/10/25
Last modified on 2023/12/20 13:43:58

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Basic information

Public title

Developing Health Promotion Program based on Wearable ICT and Collective Responsibility

Acronym

Developing Health Promotion Program based on Wearable ICT and Collective Responsibility

Scientific Title

Developing Health Promotion Program based on Wearable ICT and Collective Responsibility

Scientific Title:Acronym

Developing Health Promotion Program based on Wearable ICT and Collective Responsibility

Region

Japan


Condition

Condition

lifestyle related disease

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This research is to evaluate the effect of incentives given by social game based on collective responsibility for health promotion

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Continuing Health Promotion Activity 1/3/12 months after the initial event

Key secondary outcomes



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

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Attend 10 days social game event

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Ones who want to attend the event and who had taken special medical checkup

Key exclusion criteria

Ones who'd better to avoid long-term walking due to health condition.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Kuroda

Organization

Kyoto University

Division name

Division of Medical IT and Admin Plan

Zip code

606-8507

Address

Shogo-in Kawahara-cho 54, Kyoto, Japan

TEL

075-751-3646

Email

tomo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Kuroda

Organization

Kyoto University

Division name

Div Medical IT and Admin Plan

Zip code

606-8507

Address

Shogo-in Kawahara-cho 54, Kyoto, Japan

TEL

075-751-3646

Homepage URL


Email

tomo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

City of Nagahama, Ritsumeikan Univ. Kinki Univ.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Comittee

Address

Yoshida-Konoe-Cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

2014 Year 10 Month 25 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

179

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Due to heavy task load of researcher who is responsible to analysis

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

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 10 Month 10 Day

Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2019 Year 04 Month 08 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 20 Day

Last modified on

2023 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name