UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043652 |
|---|---|
| Receipt number | R000049852 |
| Scientific Title | Intervention study on body image recognition |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2025/09/30 14:53:10 |
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Basic information
Public title
Intervention study on body image recognition
Acronym
Intervention study on body image recognition
Scientific Title
Intervention study on body image recognition
Scientific Title:Acronym
Intervention study on body image recognition
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By performing intervention, we'll try to decrease body image disturbance of healthy people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body image disturbance measured by a psychological experiment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
We'll perform a gaze induction intervention for perceptual body image distortion (difficulty in estimating one's own body size accurately), which is one of the body image disturbances. In the intervention group, participants will be instructed to look at whole body evenly, and then judge if the silhouette image is more overweight than themselves. In the control group, participants will be instructed to look at a particular body part, and then judge if the silhouette image is more overweight than themselves.
Interventions/Control_2
We'll perform a mirror exposure intervention for affective-evaluative body image dissatisfaction (feeling of overweight due to dissatisfaction toward one's own body), which is one of the body image disturbances. In the intervention group, participants will look at their body in the mirror, and then objectively describe a particular body part. In the control group, participants will imagine a particular body part and objectively describe about it.
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy right-handed adult female
Key exclusion criteria
Male
A person who has previous history of any psychiatric disorders, who has metal in his or her body, who has strong myopia, who is during pregnancy, who has claustrophobia, who is left-handed.
Target sample size
80
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
motoaki.sugiura.d6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hamamoto |
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
Homepage URL
motoaki.sugiura.d6@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
| 2021 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1337776/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1337776/full
Number of participants that the trial has enrolled
32
Results
Participants who reduced perceptual disturbance exhibited an activation increase in visual processing brain regions. On the other hand, participants who reduced affective disturbance exhibited an activation changes in socio-cognitive processing regions.
Results date posted
| 2025 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-two non-clinical women were recruited from the undergraduate or graduate school of Tohoku University (n = 28) or the nearby general population (n = 4). We excluded males as well as individuals who were left-handed, aged< 20 or > 35 years, pregnant, or following weight-loss plans. Individuals with a history of psychiatric disorders, claustrophobia, or metal implants were also excluded from the study. The history of psychiatric disorders was self-reported rather than physician-assessed. Half of them (n=16) were assigned to the mirror exposure group, and the others were assigned to the imagery exposure group.
Participant flow
Four participants were excluded from the analysis due to body movements, and 14 participants were assigned to each group.
Adverse events
None
Outcome measures
Changes in neural responses related to the reduction in two components of body image disturbance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049852
