UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023488 |
|---|---|
| Receipt number | R000027051 |
| Scientific Title | Neural basis of a mechanism producing individual difference about body image |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2024/02/12 22:17:43 |
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Basic information
Public title
Neural basis of a mechanism producing individual difference about body image
Acronym
Neural basis of a mechanism producing individual difference about body image
Scientific Title
Neural basis of a mechanism producing individual difference about body image
Scientific Title:Acronym
Neural basis of a mechanism producing individual difference about body image
Region
| Japan |
Condition
Condition
Eating Disorders
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We'll research if healthy people have distorted body image which patients of anorexia nervosa have. We hypothesize that some healthy people have distorted body image, and from their brain imaging data, we'll show neural basis causing distorted body image.
Basic objectives2
Others
Basic objectives -Others
Brain imaging
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distorted body image(evaluation): We'll show distorted pictures of subjects and others to subjects and ask subjects that, "Do you think the woman in this image is fat?"
We'll check the difference between subjects' self-evaluation and evaluation of others. We also check brain imaging data.
Key secondary outcomes
Distorted body image(estimation): We'll show distorted pictures of subjects to them and have subjects estimate whether or not the picture is fatter than the their actual body image.
We'll check the difference between subjects' estimation and the actual image. We also check brain imaging data.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We have subjects do 2 tasks, body image estimation task and body image evaluation task.
In body image estimation task, subjects will look at their distorted pictures and they will be answer a question about each picture. The question is that, "Do you think the body image in the picture is fatter than actual your body image?"
In body image evaluation task, subjects will look at distorted pictures of them and other people. And they will answer a question about each picture. The question is that, "Do you think the woman in this picture is fat?"
We'll have subjects do these 2 tasks for 2 times.
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
Healthy right-handed female in undergraduate schools or graduate schools
Key exclusion criteria
A person who has previous history of any psychiatric disorders, who has metal in her body, who has strong myopia, who is during pregnancy, who has claustrophobia, who is left-handed.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motoaki |
| Middle name | |
| Last name | Sugiura |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer, Dept. Human Brain Science
Zip code
980-8575
Address
3F International Center for Smart Ageing Research, Seiryo-machi 4-1, Aoba-ku Sendai, Miyagi
TEL
022-717-8563
sugiura@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hamamoto |
Organization
Tohoku University
Division name
School of Medicine
Zip code
980-8575
Address
3F International Center for Smart Ageing Research, Seiryo-machi 4-1, Aoba-ku Sendai, Miyagi
TEL
022-717-8563
Homepage URL
yumi.hamamoto.q2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, School of Medicine, Tohoku University
Address
Seiryo-machi, 2-1, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2016 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000027051
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0166432823000670?via%3Dihub
Number of participants that the trial has enrolled
41
Results
Distinct neural correlates of each component of body-image disturbance were observed. Perceptual disturbance was associated with saliency-detection activation. On the ohter hand, affective disturbance was associated with social-processing activation.
Results date posted
| 2022 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female right-handed undergraduate and graduate students in Tohoku University.
Participant flow
Participants were recruited via advertisement from the university office. There was no follow-up after data correction.
Adverse events
None
Outcome measures
fMRI data, behavioural data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027051
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