UMIN-CTR Clinical Trial

Basic information
Public title	A Trial on Improvement of a Hospital Employees' Dietary Habits
Acronym	A Trial on Improvement of a Hospital Employees' Dietary Habits
Scientific Title	A Trial on Improvement of a Hospital Employees' Dietary Habits
Scientific Title:Acronym	A Trial on Improvement of a Hospital Employees' Dietary Habits
Region	Japan

Condition
Condition	Lifestyle related diseases
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effects of a hospital food environment intervention on employees' dietary habits
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinary sodium-to-potassium ratio 1 year after the start of intervention
Key secondary outcomes	Estimated 24hour sodium excretion Estimated 24hour potassium excretion Food groups intake

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	Food Behavior,custom
Interventions/Control_1	Food environment intervention
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	All employees of a hospital
Key exclusion criteria	Those who refused to participate Those who with incomplete data
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Teruko Middle name Last name Kawabata
Organization	Japan Association for Development of Community Medicine
Division name	Institute of Community Medicine Health Promotion Research Center
Zip code	102-0093
Address	Todofuken Kaikan Bidg.15th floor 2-6-3 Hirakawa-cho, Chiyoda-ku, Tokyo 102-0093
TEL	03-5212-9152
Email	terukoka@jadecom.jp

Public contact
Name of contact person	1st name Teruko Middle name Last name Kawabata
Organization	Japan Association for Development of Community Medicine
Division name	Institute of Community Medicine Health Promotion Research Center
Zip code	102-0093
Address	Todofuken Kaikan Bidg.15th floor 2-6-3 Hirakawa-cho, Chiyoda-ku, Tokyo 102-0093
TEL	03-5212-9152
Homepage URL
Email	terukoka@jadecom.jp

Sponsor
Institute	Institute of Community Medicine Health Promotion Research Center
Institute
Department

Funding Source
Organization	Institute of Community Medicine Health Promotion Research Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	l
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethical Committee of the Japan Association for Development of Community Medicine
Address	Todofuken Kaikan Bidg.15th floor 2-6-3 Hirakawa-cho, Chiyoda-ku, Tokyo 102-0093
Tel	03-5212-9152
Email	morihidef@jadecom.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	台東区立台東病院

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 07 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
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	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 03 Month 08 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 07 Day
Last modified on	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056299