UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047880 |
|---|---|
| Receipt number | R000054343 |
| Scientific Title | A Validation Study of the Artificial Intelligence- and Mobile-supported Diet Recording for Family Members of Patients with Anorexia Nervosa |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2022/05/27 17:24:32 |
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Basic information
Public title
A Validation of AI- and Mobile-supported Diet Recording
Acronym
A Validation of AI- and Mobile-supported Diet Recording
Scientific Title
A Validation Study of the Artificial Intelligence- and Mobile-supported Diet Recording for Family Members of Patients with Anorexia Nervosa
Scientific Title:Acronym
A Validation Study of the Artificial Intelligence- and Mobile-supported Diet Recording for Family Members of Patients with Anorexia Nervosa
Region
| Japan |
Condition
Condition
Anorexia Nervosa (AN)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the AI- and Mobile-supported Diet Recording (AIMs DR) for family members of patients with AN.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will calculate the correlation between the daily energy food intake (including breakfast, lunch, and dinner) measured by participants using the AIMs DR and the same intake independently measured by a dietician using the photographs of the three meals in the app.
Key secondary outcomes
We will also calculate the correlation between 13 nutrients in the daily food (including breakfast, lunch, and dinner) measured by participants using the AIMs DR and the same nutrients independently measured by a dietician using the photographs of the three meals in the app.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include family members of the inpatients whose 1) age is between 9 and 49 years: 2) diagnosis has been confirmed according to the criteria for AN in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3) body mass index (BMI) is less than 19; 4) relation to the members are mothers, fathers, or spouses (aged 20 years or more); 5) daily meals are mainly provided by the members.
Key exclusion criteria
This study will exclude family members of the inpatients with AN who 1) are pregnant; 2) are complicated with other diseases requiring nutrition therapy; and 3) are regarded as being ineligible for AIMs DR by the attending doctor for any reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Shiraishi |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8271
nao-shiraishi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Shiraishi |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8271
Homepage URL
nao-shiraishi@umin.ac.jp
Sponsor or person
Institute
Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-858-7215
irb_jimu@med.nagoya-cu.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
| 2022 | Year | 05 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to validate the AI- and Mobile-supported Diet Recording (AIMs DR) for family members of patients with AN. We will calculate the correlation between the daily energy food intake (including breakfast, lunch, and dinner) measured by participants using the AIMs DR and the same intake independently measured by a dietician using the photographs of the three meals in the app.
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054343
