Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059246) titled 'The relationship between body image and eating behaviour' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - We will recruit healthy young females and aims to prevent developing anorexia Nervosa and bulimia Nervosa
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 05 Month 14 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067764
Disclaimer: Curated by HT Syndication.