UMIN-CTR Clinical Trial

Basic information
Public title	Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Acronym	Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Scientific Title	Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Scientific Title:Acronym	Effect of nutrition education using vegetable intake measurement device on amount of vegetable intake
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of nutritional education programs on vegetable intake.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of vegetable intake
Key secondary outcomes	TTM stage of vegetable comsunption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Participation in nutrition education program Measurement with vegetable intake measuring device
Interventions/Control_2	Participation in nutrition education program
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	healthy adults
Key exclusion criteria	Who have any vegetable allergies. Who receives meal instruction
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Nobuta
Organization	Kagome Co. LTD.
Division name	Health and wellness business department
Zip code	103-8461
Address	3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo
TEL	03-5623-8501
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 and wellness business department
Zip code	103-8461
Address	3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo
TEL	03-5623-8501
Homepage URL
Email	Yukihiro_Nobuta@kagome.co.jp

Sponsor
Institute	Kagome Co. LTD.
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	Kagawa education institute of nutrition
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagome Research Ethics Committee
Address	3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo
Tel	03-5623-8501
Email	Takuji_Hayakawa@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	2021 Year 12 Month 31 Day

Related information
URL releasing protocol	https://www.c-linkage.co.jp/kaizen67/
Publication of results	Published

Result
URL related to results and publications	https://www.c-linkage.co.jp/kaizen67/
Number of participants that the trial has enrolled	190
Results	The intervention group had increased vegetable intake and increased stages of behavioral change.
Results date posted	2021 Year 03 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	free participation
Participant flow	Fallout
Adverse events	Nothing
Outcome measures	vegetable intake
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 31 Day
Date of IRB	2019 Year 08 Month 31 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 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	2021 Year 03 Month 17 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043323