UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the association between dietary habits and health in children, adolescents and their parents
Title of the study (Brief title)	Investigation of the association between dietary habits and health in children, adolescents and their parents
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between dietary habits and health in children, adolescents and their parents
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dietary intake
Key secondary outcomes	Anthropometry (height, weight), urine (sodium, potassium, creatinine, 8-OHdG, cortisol, cotinine), blood (erythrocyte, hemoglobin, hematocrit, triacylglycerol, T-Chol, HDL-Chol, uric acid), questionnaire (SDQ, CES-D, CFS, CBIS, Figural stimuli (Body image silhouette), KTSND)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	3 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Obtained written informed consent before the participation
Key exclusion criteria	Those who felt this study was inconvenient to everyday life.
Target sample size	1600

Research contact person
Name of lead principal investigator	Toshiko Kuwano
Organization	The University of Shizuoka
Division name	School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL	054-264-5513
Email	kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Toshiko Kuwano
Organization	The University of Shizuoka
Division name	School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL	054-264-5513
Homepage URL
Email	kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute	The University of Shizuoka
Institute
Department

Funding Source
Organization	The University of Shizuoka
Organization
Division
Category of Funding Organization	Local Government
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 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 25 Day
Anticipated trial start date	2014 Year 08 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	Questionnaire survey of dietary habits and health or urinary test and blood test are performed to children, adolescents and their parents.

Management information
Registered date	2018 Year 06 Month 26 Day
Last modified on	2018 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037797