UMIN-CTR Clinical Trial

Basic information
Public title	Effect of nutrition education programmes presenting contributions to the SDGs on vegetable intake among worker
Acronym	Effect of nutrition education programmes presenting contributions to the SDGs on vegetable intake
Scientific Title	Effect of nutrition education programmes presenting contributions to the SDGs on vegetable intake among worker
Scientific Title:Acronym	Effect of nutrition education programmes presenting contributions to the SDGs on vegetable intake
Region	Japan

Condition
Condition	healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of nutrition education programmes on the vegetable intake of worker.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of vegetable intake
Key secondary outcomes	Attitudes and behaviours related to vegetable intake.

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
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Provide nutrition education programmes that present healthcare outcomes.
Interventions/Control_2	Provide nutrition education programmes that present social outcomes in additional of healthcare outcomes.
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	99 years-old >
Gender	Male and Female
Key inclusion criteria	worker
Key exclusion criteria	People receiving dietary guidance from a healthcare professional.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Nobuta
Organization	Kagome Co., LTD
Division name	Health & Business Department
Zip code	103-8461
Address	Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
TEL	08015735832
Email	Yukihiro_Nobuta@kagome.co.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Nobuta
Organization	KAGOME CO., LTD.
Division name	Health & Business Department
Zip code	103-8461
Address	Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
TEL	08015735832
Homepage URL
Email	Yukihiro_Nobuta@kagome.co.jp

Sponsor
Institute	KAGOME CO., LTD. Health & Business Department
Institute
Department

Funding Source
Organization	KAGOME CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kagome Research Ethics Review Board
Address	Nihonbashi-Hamacho F Tower, 3-21-1Nihonbashi-Hamacho, Chuo-ku, Tokyo
Tel	08015735832
Email	Yukihiro_Nobuta@kagome.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	2023 Year 06 Month 30 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	2022 Year 04 Month 21 Day
Date of IRB	2022 Year 04 Month 21 Day
Anticipated trial start date	2022 Year 08 Month 19 Day
Last follow-up date	2023 Year 02 Month 28 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 04 Month 04 Day
Last modified on	2022 Year 04 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054050