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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035787
Receipt No. R000040767
Scientific Title Examination of the support for school refusal children
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/06

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Basic information
Public title Examination of the support for school refusal children
Acronym Examination of the support for school refusal children
Scientific Title Examination of the support for school refusal children
Scientific Title:Acronym Examination of the support for school refusal children
Region
Japan

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

Objectives
Narrative objectives1 To examine the support for school refusal children
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, BMI, body fat percentage, blood pressure, grip strength), blood (erythrocyte, hemoglobin, hematocrit, triacylglycerol, T-Chol, HDL-Chol, uric acid), autonomic nerve function, chewing ability, bone density, sleep apnea examination, questionnaire (WHO QOL26, KINDL, STAI, STAI-C, SDQ, CES-D, K6, CFS, JPSS, GFS)

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
11 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 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiko Kuwano
Organization The University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code
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
1st name
Middle name
Last name Toshiko Kuwano
Organization The University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 07 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Dietary assessment, questionnaire survey about dietary habits and health, urinary test and blood test are performed to adolescents and their parents.

Management information
Registered date
2019 Year 02 Month 06 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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