UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042411
Receipt number R000046381
Scientific Title Effect of influencer on physical activity
Date of disclosure of the study information 2020/11/11
Last modified on 2023/11/17 18:24:21

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Basic information

Public title

Effect of influencer on physical activity

Acronym

Effect of influencer on physical activity

Scientific Title

Effect of influencer on physical activity

Scientific Title:Acronym

Effect of influencer on physical activity

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of physical activity intervention by influencer using social networking service.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical activity (steps) in a month

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Participants in the intervention group receive a tailored message from an influencer (Intervention group).
7 days for baseline measurement and 30 days for intervention.
Messages will be sent to each participant to increase 1000 steps in daily steps, which is determined from the baseline assessment.
Messages will be sent every day.

Interventions/Control_2

Participants in the control group receive an automated message from an influencer (Control group).
Other conditions will be the same as those in the intervention group.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Residents living in Japan who follow a micro-influencer.

Key exclusion criteria

Those who have disabilities or diseases that prevent from walking.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Ryosuke
Middle name
Last name Shigematsu

Organization

Mie University

Division name

Faculty of Education

Zip code

5148507

Address

1577 Kurimamachiya, Tsu, Mie, Japan

TEL

+81592319294

Email

rshige@gmail.com


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Shigematsu

Organization

Mie University

Division name

Faculty of Education

Zip code

5148507

Address

1577 Kurimamachiya, Tsu, Mie, Japan

TEL

+81592319294

Homepage URL


Email

rshige@gmail.com


Sponsor or person

Institute

Mie University

Institute

Department

Personal name



Funding Source

Organization

Mie University

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

Faculty of Education, Mie University

Address

1577 Kurimamachiya, Tsu, Mie, Japan

Tel

+81592319294

Email

rshige@gmail.com


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

2020 Year 11 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

140

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

not analyzed

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

No longer recruiting

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 11 Month 19 Day

Anticipated trial start date

2019 Year 11 Month 20 Day

Last follow-up date

2019 Year 12 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 11 Day

Last modified on

2023 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046381


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name