UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050961 |
|---|---|
| Receipt number | R000058044 |
| Scientific Title | Desire for weight loss Behavior Associated with Food Attention Bias Examination by Event-Related Potentials |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/03/20 11:39:20 |
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Basic information
Public title
Desire for weight loss Associated with Food Attention Bias
Examination by Event-Related Potentials
Acronym
Desire for weight loss Associated with Food Attention Bias
Examination by Event-Related Potentials
Scientific Title
Desire for weight loss Behavior Associated with Food Attention Bias
Examination by Event-Related Potentials
Scientific Title:Acronym
Desire for weight loss for weight loss Weight Loss Behavior Associated with Food Attention Bias
Examination by Event-Related Potentials
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between weight loss behavior and desire to lose weight and attentional bias toward food pictures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validating Attention Bias to Food by Event-Related Potentials
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
For the group with greater weight loss desire, EEG is measured in two conditions: non-food images and food images
(1) Passive viewing condition
(2) Condition of button pressing
Finally, the images are evaluated.
Interventions/Control_2
For the group with small weight loss desire, measure EEG under two conditions: non-food images and food images
(1) Passive viewing condition
(2) Condition of pressing a button
Finally, the images will be evaluated.
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students from the Departments of Health and Nutrition, Health and Sports, Physical Therapy (1st-4th year), and Graduate School are invited to apply, and healthy female undergraduate students who agree with the content of the research and decide to participate of their own free will will will be selected.
Key exclusion criteria
Exclusion criteria include those with physical or mental illnesses or those taking medications because of their influence on EEG measurements.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ayano |
| Middle name | |
| Last name | Kondo |
Organization
Niigata university of health and welfare
Division name
Department of Health and Nutrition
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4413
whm22001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Kondo |
Organization
Niigata university of health and welfare
Division name
Department of Health and Nutrition
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4413
Homepage URL
whm22001@nuhw.ac.jp
Sponsor or person
Institute
Niigata university of health and welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata university of health and welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata university of health and welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4413
whm22001@nuhw.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
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | 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
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058044
