UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the effect of nutrition education program for workers on consciousness and behavior of eating habits on vegetable intake.
Title of the study (Brief title)	Effect of nutrition education program for workers on their vegetable intake.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of transtheoretical model of vegetable intake on nutrition education program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Transtheoretical model of vegetable consumption.
Key secondary outcomes	1. Habitant background 2. Change factor of transtheoretical model of vegetable consumption.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Nutrition Education
Interventions/Control_2	not intervention
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	Workers
Key exclusion criteria	1. Allergic to any vegetables 2. Dietary restriction to any vegetables
Target sample size	500

Research contact person
Name of lead principal investigator	Tomoko Sone
Organization	Kagome Co. Ltd.
Division name	Health business department
Address	3-21-1, Nihonbashi Hamacho, Tyuo ward, Tokyo
TEL	03-5623-8501
Email	Tomoko_Sone@kagome.co.jp

Public contact
Name of contact person	Yukihiro Nobuta
Organization	Kagome Co. Ltd.
Division name	Health business department
Address	3-21-1, Nihonbashi Hamacho, Tyuo ward, Tokyo
TEL	03-5623-8501
Homepage URL
Email	Yukihiro_Nobuta@kagome.co.jp

Sponsor
Institute	Kagome Co., Ltd.
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kagawa Nutrition University
Name of secondary funｄer(s)	None

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	神奈川県内の企業（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 09 Month 20 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039009