UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035787
Receipt number R000040767
Scientific Title Examination of the support for school refusal children
Date of disclosure of the study information 2019/02/07
Last modified on 2023/02/09 10:18:28

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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 Toshiko
Middle name
Last name Kuwano

Organization

The University of Shizuoka

Division name

School of Food and Nutritional Sciences

Zip code

422-8526

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 Toshiko
Middle name
Last name Kuwano

Organization

The University of Shizuoka

Division name

School of Food and Nutritional Sciences

Zip code

422-8526

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 or person

Institute

The University of Shizuoka

Institute

Department

Personal name



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

The Ethics Committee of the University of Shizuoka

Address

52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan

Tel

054-264-5103

Email

tyous10@u-shizuoka-ken.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

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

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 19 Day

Date of IRB

2017 Year 02 Month 03 Day

Anticipated trial start date

2017 Year 02 Month 03 Day

Last follow-up date

2022 Year 03 Month 31 Day

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

2023 Year 02 Month 09 Day



Link to view the page

Value
https://center6.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