UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033234 |
|---|---|
| Receipt number | 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 | 2024/01/05 23:10:50 |
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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
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
oshimay@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view_his.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view_his.cgi
Number of participants that the trial has enrolled
20
Results
The project was cancelled as the number of cases could not be secured.
Results date posted
| 2024 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(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
Participant flow
Three implicit association tests (FOOD-IAT, BODY-IAT and FOOD/BODY-IAT) were administered to participants who agreed to participate in the study after being informed of the study content.
Adverse events
No adverse events occurred.
Outcome measures
D scores or response latencies of FOOD-IAT, BODY-IAT, FOOD/BODY-IAT in AN group and no AN group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | 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
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037823
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
