UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044879
Receipt number R000051134
Scientific Title Impact of tailor-made recommendations for employee health programs
Date of disclosure of the study information 2021/07/19
Last modified on 2021/07/14 16:37:26

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Basic information

Public title

Impact of tailor-made recommendations for employee health programs

Acronym

Impact of tailor-made recommendations for employee health programs

Scientific Title

Impact of tailor-made recommendations for employee health programs

Scientific Title:Acronym

Impact of tailor-made recommendations for employee health programs

Region

Japan


Condition

Condition

None (Healthy)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Regarding the "health promotion program" provided by the company to employees, we aim to clarify what kind of differences of the effect between these three approaches.(1) recommendations based on "cluster analysis" which based on the results of the employee's own health diagnosis and surveys,(2)random recommendations(3)no recommendations.

Basic objectives2

Others

Basic objectives -Others

Evaluate whether "recommendation of optimal content" is effective as an approach that companies take to improve employee health

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Browsing rate of articles and videos developed in the "Health Promotion Program"

Key secondary outcomes

Results of the 2021 health examination of employees


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Send a video link of the health promotion program that suits the person based on "cluster analysis" by e-mail a total of 6 times a week

Interventions/Control_2

Send random health promotion program video links by email 6 times a week

Interventions/Control_3

Send a total of 6 weekly page links to the entire health promotion program by email

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

(1) Employees of Hakuhodo DY holdings Inc. or Hakuhodo Inc. or Hakuhodo DY Media Partners Inc.
(2) Employees who have a record of health checkups last year
(3) Employees who voluntarily requested feedback on "cluster analysis results"

Key exclusion criteria

None

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Shinya
Middle name
Last name Tokuhisa

Organization

Hakuhodo DY holdings Inc.

Division name

Marketing technology depelopment division, Solution development department2

Zip code

107-6322

Address

Akasaka 5-3-1, Minato-ku, Tokyo

TEL

03-6441-8111

Email

shinya.tokuhisa@hakuhodody-holdings.co.jp


Public contact

Name of contact person

1st name Seiya
Middle name
Last name Sonoda

Organization

Hakuhodo DY holdings Inc.

Division name

Marketing technology depelopment division, Solution development department2

Zip code

107-6322

Address

Akasaka 5-3-1, Minato-ku, Tokyo

TEL

03-6441-8111

Homepage URL


Email

seiya.sonoda@hakuhodody-holdings.co.jp


Sponsor or person

Institute

Hakuhodo DY holdings Inc.
Marketing technology depelopment division, Solution development department2

Institute

Department

Personal name



Funding Source

Organization

None

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

Hakuhodo DY holdings Inc.

Address

Akasaka 5-3-1, Minato-ku, Tokyo

Tel

03-6441-8111

Email

seiya.sonoda@hakuhodody-holdings.co.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 07 Month 19 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

Preinitiation

Date of protocol fixation

2021 Year 07 Month 19 Day

Date of IRB


Anticipated trial start date

2021 Year 07 Month 19 Day

Last follow-up date

2021 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 16 Day

Last modified on

2021 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name