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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038788
Receipt No. R000044220
Scientific Title Psychological characteristics of Japanese obese children
Date of disclosure of the study information 2019/12/04
Last modified on 2019/12/04

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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
Institute Haga Red Cross Hospital Ethics Committee
Institute
Department

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 Enrolling by invitation
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 08 Month 31 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
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.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


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