UMIN-CTR Clinical Trial

Basic information
Public title	A study on methods of providing information for behavioral modification of vegetable intake by lifestyle and stages of behavior change among young people
Acronym	A study on methods of providing information for behavioral modification of vegetable intake among young people
Scientific Title	A study on methods of providing information for behavioral modification of vegetable intake by lifestyle and stages of behavior change among young people
Scientific Title:Acronym	A study on methods of providing information for behavioral modification of vegetable intake among young people
Region	Japan

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

Objectives
Narrative objectives1	This study aims to examine the changes of vegetable intake of young people by providing information for behavioral modification of vegetable intake in different methods by lifestyle and stages of behavior of the subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of vegetable intake of the subjects by providing information for behavioral modification of vegetable intake in different methods, at the end of one-month intervention (providing information) and another one month after the end of intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group will be provided information for promoting vegetable intake (nutrients expected by eating vegetables: 2 topics, health effects of nutrients from vegetables: 2 topics, nutrients and health effects in specific vegetable: 2 kinds, how to take vegetables easily: 2 topics) through SNS messages twice a week for one month.
Interventions/Control_2	The same information will be collectively provided at once to the control group through SNS messages.
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	22 years-old >=
Gender	Female
Key inclusion criteria	Healthy people
Key exclusion criteria	Foreigner
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Mizumoto Middle name Last name Kaori
Organization	Nakamura Gakuen University
Division name	Department of Food Management, Faculty of Nutritional Sciences
Zip code	814-0198
Address	5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
TEL	092-851-2867
Email	kmizumoto@nakamura-u.ac.jp

Public contact
Name of contact person	1st name Mizumoto Middle name Last name Kaori
Organization	Nakamura Gakuen University
Division name	Department of Food Management, Faculty of Nutritional Sciences
Zip code	814-0198
Address	5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
TEL	092-851-2867
Homepage URL
Email	kmizumoto@nakamura-u.ac.jp

Sponsor
Institute	Other
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Review Board for Research Involving Human Subjects, Nakamura Gakuen University and Junior College
Address	5-7-1 Befu, Jonan-ku, Fukuoka City, Fukuoka
Tel	092-851-2531
Email	kks@nakamura-u.ac.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	2020 Year 10 Month 15 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	Completed
Date of protocol fixation	2020 Year 08 Month 05 Day
Date of IRB	2020 Year 08 Month 05 Day
Anticipated trial start date	2020 Year 10 Month 18 Day
Last follow-up date	2021 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	2020 Year 10 Month 15 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048088