UMIN-ICDS Clinical Trial

Public title

Testing the effectiveness of training to divert attention away from food

Acronym

Effects of Attention Modification Training from Food

Scientific Title

Testing the Effectiveness of Attention Bias Modification Training to Divert Attention from Food

Scientific Title:Acronym

Testing the Effectiveness of Attention Bias Modification Training for Food

Region

Japan

Condition

Obesity

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will focus on the differences in attention bias due to body size, conduct attention bias modification training to divert attention away from food, and verify the effects on eating behavior.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1) Self-assessment scale (questionnaire)
1. Hunger and Satiety Scale
2. face items
Gender, age, height, weight, tendency of eating behavior, etc.
3. Japanese version of the DEBQ scale
4. PANAS scale (Japanese translation of Watson et al., 1988)

(2) Visual probe task
In this task to measure attentional bias, two stimulus images are presented, one on each side of the screen, for 2 seconds after a 1-second presentation of the gazing point (+) in the center of the PC screen. The subject is then asked to press the button on the same side as the point displayed on either side of the screen. The stimulus image is a high-fat food (e.g., pizza) and the comparison image is a musical instrument. The subject's eye movements (gazing time) are also measured. The eye movements are measured using Tobbi's Pro Nano eye tracker.

(3) Modified version of the visual probe task
In this task for correcting attentional bias, the gazing point (+) in the center of the PC screen is presented for 0.5 seconds, and then two stimulus images are presented for 2 seconds, one on each side of the screen. The intervention group then has a point (*) appear at the location of the neutral image (instrument) on each trial to divert attention away from the high-lipid food image (e.g., pizza). For the placebo group, the position of the dot (*) will be randomized on a trial-by-trial basis. The subjects' eye movements (gazing time) will be measured during the trials. The eye movements will be measured using Tobii's Pro Nano eye tracker.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Intervention group (Attention bias modification training group: distracting attention from food)

Interventions/Control_2

Placebo group (random attention to food/neutral objects)

Interventions/Control_3

Control group (no training)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

The study will include 30 participants who are between 18 and 65 years of age and have a BMI of less than 25 and 30 obese participants who have a BMI of 25 or more.

Key exclusion criteria

Patients who have been hospitalized, hospitalized, or treated with medication in the past or at the time of participation in the study due to underlying diseases or psychiatric symptoms will be excluded from the study.

Target sample size

60

Name of lead principal investigator

1st name	Junko
Middle name
Last name	Kawahito

Organization

Kagawa University

Division name

medical faculty

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture

TEL

0878985111

Email

kawahito.junko@kagawa-u.ac.jp

Name of contact person

1st name	Junko
Middle name
Last name	Kawahito

Organization

Kagawa University

Division name

medical faculty

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture

TEL

0878985111

Homepage URL

Email

kawahito.junko@kagawa-u.ac.jp

Institute

Kagawa University

Institute

Department

Personal name

Organization

Kagawa University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kagawa University

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture

Tel

0878985111

Email

kawahito.junko@kagawa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

12

Month

07

Day

Date of IRB

2023

Year

12

Month

07

Day

Anticipated trial start date

2024

Year

04

Month

03

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

04

Month

03

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061706