UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of dietary education focusing on decreasing leftover for preschool children
Title of the study (Brief title)	Usefulness of dietary education
Region	Japan

Condition
Condition	Children
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective was to evaluate the usability of the dietary education program focusing on leftover among preschool children.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the amount of children's leftovers in the duration of the whole study
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
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	We evaluate the each child's leftover at base-line and end-line. The intervention group will be educated about decreasing leftover.
Interventions/Control_2	We evaluate the each child's leftover at base-line and end-line. The control group will not be educated about decreasing leftover.
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	4 years-old <=
Age-upper limit	5 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy preschool children
Key exclusion criteria	Nothing
Target sample size	500

Research contact person
Name of lead principal investigator	Mikako Nagafuchi
Organization	Nakamura Gakuen Junior College
Division name	Division of Infant Education
Address	5-7-1 Befu Jonan-ku Fukuoka Japan
TEL	092-851-2531
Email	nagafu-m@nakamura-u-ac.jp

Public contact
Name of contact person	Mikako Nagafuchi
Organization	Nakamura Gakuen Junior College
Division name	Division of Infant Education
Address	5-7-1 Befu Jonan-ku Fukuoka Japan
TEL	092-851-2531
Homepage URL
Email	nagafu-m@nakamura-u-ac.jp

Sponsor
Institute	Nakamura Gakuen Junior College
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2018 Year 06 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 10 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 06 Month 21 Day
Last modified on	2018 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037543