UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038788
Receipt number R000044220
Scientific Title Psychological characteristics of Japanese obese children
Date of disclosure of the study information 2019/12/04
Last modified on 2020/05/10 14:57:41

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Basic information

Public title

Psychological characteristics of Japanese obese children

Acronym

Psychological characteristics of Japanese obese children

Scientific Title

Psychological characteristics of Japanese obese children

Scientific Title:Acronym

Psychological characteristics of Japanese obese children

Region

Japan


Condition

Condition

Child obese

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the eating behavior and psychological characteristics of obese children.

Basic objectives2

Others

Basic objectives -Others

To analyze the relationship between eating behavior and psychological characteristics of obese children.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the score of eating behavior questionnaire and psychosomatic disorder questionnaire in obese children with non-obese children.

Key secondary outcomes



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

6 years-old <

Age-upper limit

16 years-old >

Gender

Male and Female

Key inclusion criteria

school children

Key exclusion criteria

children who can not answere to the questionnaires

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Mari
Middle name
Last name Saito

Organization

Haga Red Cross Hospital

Division name

Pediatrics

Zip code

3214306

Address

271 Nakago Mouka Tochigi

TEL

0285822195

Email

mari.saito@haga.jrc.or.jp


Public contact

Name of contact person

1st name Mari
Middle name
Last name Saito

Organization

Haga Red Cross Hospital

Division name

Pediatrics

Zip code

3214306

Address

271 Nakago Mouka Tochigi

TEL

0285822195

Homepage URL


Email

mari.saito@haga.jrc.or.jp


Sponsor or person

Institute

Haga Red Cross Hospital Ethics Committee

Institute

Department

Personal name



Funding Source

Organization

Haga Red Cross Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Haga Red Cross Hospital Ethics Committee

Address

271 Nakago Mouka Tochigi

Tel

0285822195

Email

y.kikuchi@haga.jrc.or.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 12 Month 04 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

2019 Year 12 Month 04 Day

Date of IRB

2019 Year 11 Month 02 Day

Anticipated trial start date

2019 Year 12 Month 04 Day

Last follow-up date

2020 Year 05 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Compare the scores of the dietary behavior questionnaire and psychosomatic disorder questionnaire of obese children with those of non-obese children, and analyze the features of dietary behavior and psychological state in obese children.

Then, analyze the relationship between eating behavior and psychosomatic disorder aspects of obese children.


Management information

Registered date

2019 Year 12 Month 04 Day

Last modified on

2020 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name