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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033234
Receipt No. R000037823
Scientific Title A study of implicit attitudes toward food and body for people with anorexia nervosa using the Implicit Association Test(IAT)
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/02

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Basic information
Public title A study of implicit attitudes toward food and body for people with anorexia nervosa using the Implicit Association Test(IAT)
Acronym Anorexia nervosa and the Implicit Association Test(IAT)
Scientific Title A study of implicit attitudes toward food and body for people with anorexia nervosa using the Implicit Association Test(IAT)
Scientific Title:Acronym Anorexia nervosa and the Implicit Association Test(IAT)
Region
Japan

Condition
Condition anorexia nervosa
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measuring attitudes toward "food" and "body weight/shape of body" for people with anorexia nervosa
Basic objectives2 Others
Basic objectives -Others Clinical availability
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes D scores or response latencies of FOOD-IAT, BODY-IAT, FOOD/BODY-IAT in AN group and no AN group
Key secondary outcomes 1 Demography(age, height, weight etc.)
2 Diagnosis of anorexia nervosa
3 Type of anorexia nervosa
4 EAT-26

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 The Implicit Association Test(FOOD-IAT, BODY-IAT, FOOD/BODY-IAT)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (a) AN group
Patients who receive medical care in Department of Neuropsychiatry of Okayama University Hospital (inpatients and outpatients)

Diagnosis of anorexia nervosa according to the DSM-5 criteria

Patients who can fully understand this study and give written informed consent for the participation in this study

(b) no AN group

Okayama University students or Okayama University Hospital officials who can fully understand this study and give written informed consent for the participation in this study

BMI>=18.5

EAT-26 score<=19
Key exclusion criteria (a) no AN group
Patients who rejected or withdrew informed consent

Patients who are not appropriate for participation in the study as judged by the physician (because of physical or mental state etc.)

Patients who are not proficient in Japanese

Patients who need complete rest


Persons who rejected or withdrew informed consent

Persons who are difficult to answer fully (e.g. 0they are not proficient in Japanese, etc.)

Due to missing of background information, it is impossible to identify responders.

At least one missing in EAT-26
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seishi Terada
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Neuropsychiatry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL 086-235-7242
Email terada@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Ohshima
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Neuropsychiatry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL 086-235-7242
Homepage URL
Email oshimay@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Okayama University Graduate School of Education
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
2018 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037823

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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