UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059246 |
|---|---|
| Receipt number | R000067764 |
| Scientific Title | Elucidation of the Mechanisms Underlying the Interaction Between Body Image and Eating Behaviour |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/30 17:45:38 |
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Basic information
Public title
The relationship between body image and eating behaviour
Acronym
Body-eat relationship
Scientific Title
Elucidation of the Mechanisms Underlying the Interaction Between Body Image and Eating Behaviour
Scientific Title:Acronym
Body-eat relationship
Region
| Japan |
Condition
Condition
We will recruit healthy young females and aims to prevent developing anorexia Nervosa and bulimia Nervosa
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that individuals with anorexia nervosa and bulimia nervosa experience not only disordered eating but also body image disturbances. This study, conducted at the Undergraduate and Graduate Schools of Tohoku University, targeted healthy young women. Through a weekly intervention over one month, it aimed to improve their perception of their own bodies as being overweight. The research sought to elucidate changes in body image disturbances and eating behaviours, along with the underlying brain activity associated with these changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural response changes before and immediately after a one-month intervention
Key secondary outcomes
Changes in threshold BMI before and after the intervention
Changes in the strength of the two aspects of distortion before and after the intervention
Changes in questionnaire scores before and after the intervention
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will perform the task once a week for one month. First, they will view a female 3D image (BMI 8-35, varying in increments of 1) for 3 seconds and respond by pressing a button to indicate either "fat / not fat" or "thin / not thin". Next, participants will view the same image again and respond once more with "fat / not fat" or "thin / not thin" using the button press, but this time they will receive feedback indicating whether their response was correct or incorrect. In the intervention group, the feedback will be manipulated in a way that shifts the judgment threshold toward a 3-BMI-unit higher value (thus, participants in the intervention group will receive more "incorrect" feedback). Whether the threshold should be based on "fat / not fat" or "thin / not thin" will be determined through a preliminary experiment.
Interventions/Control_2
Participants will perform the task once a week for one month. First, they will view a female 3D image (BMI 8-35, varying in increments of 1) for 3 seconds and respond by pressing a button to indicate either "fat / not fat" or "thin / not thin". Next, participants will view the same image again and respond once more with "fat / not fat" or "thin / not thin" using the button press, but this time they will receive feedback indicating whether their response was correct or incorrect. In the control group, the feedback will be provided in a way that does not alter the original judgment threshold. Whether the threshold should be based on "fat / not fat" or "thin / not thin" will be determined through a preliminary experiment.
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals with a Body Shape Questionnaire score of 40 points or above, who are right-handed, and who do not have any contraindications for MRI
Key exclusion criteria
Individuals with a history of psychiatric disorders, those who participated in a preliminary experiment, those with food allergies, those following a vegetarian or vegan diet for reasons of personal conviction rather than health, and those with religious dietary restrictions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Hamamoto |
Organization
Tohoku University
Division name
Frontier Research Institute for Interdisciplinary Sciences
Zip code
980-0845
Address
Aramaki aza Aoba 6-3, Aoba-ku, Sendai, Miyagi
TEL
022-795-5755
yumi.hamamoto.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hamamoto |
Organization
Tohoku University
Division name
Frontier Research Institute for Interdisciplinary Sciences
Zip code
980-0845
Address
Aramaki aza Aoba 6-3, Aoba-ku, Sendai, Miyagi
TEL
08054056260
Homepage URL
yumi.hamamoto.c7@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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@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
| 2025 | Year | 09 | Month | 30 | 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
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 09 | Month | 30 | 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=R000067764
