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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043652
Receipt No. R000049852
Scientific Title Intervention study on body image recognition
Date of disclosure of the study information 2021/03/17
Last modified on 2021/03/17

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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
Email 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
Email motoaki.sugiura.d6@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
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
2020 Year 12 Month 07 Day
Date of IRB
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
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049852

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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