UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051134