UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045161 |
|---|---|
| Receipt number | R000051592 |
| Scientific Title | Objective assessment of the mutual impact of online co-eating experiences |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/15 18:28:40 |
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Basic information
Public title
Objective assessment of the mutual impact of online co-eating experiences
Acronym
Objective assessment of the mutual impact of online co-eating experiences
Scientific Title
Objective assessment of the mutual impact of online co-eating experiences
Scientific Title:Acronym
Objective assessment of the mutual impact of online co-eating experiences
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare and examine the difference in the effects of eating alone and eating together online using objective evaluations such as heart rate variability and facial expression analysis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in heart rate variability
Key secondary outcomes
psychological assessment
external expression of QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
co-eating
Interventions/Control_2
solitary eating
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
1) Those who are 20 years of age or older at the time of obtaining consent (regardless of gender)
2) Those who have received sufficient explanation before participating in this study, and who have obtained the consent of the document by their own free will after sufficient understanding.
Key exclusion criteria
1) Patients with severe hepatic or renal dysfunction
2) Uncontrolled diabetics
3) Women who are pregnant or may become pregnant
4) Lactating women
5) Patients who received other study drug or study drug within 3 months of obtaining consent
6) Those with arrhythmia
7) Persons whose main illness is mental illness
8) Those who lack the ability to express their intentions
9) In addition, those who the principal investigator deems inappropriate as research subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University Hospital
Division name
Psychosomatic and General Internal Medicine
Zip code
5731191
Address
2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University Hospital
Division name
Psychosomatic and General Internal Medicine
Zip code
5731191
Address
2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of psychosomatic medicine, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kansai Medical University Hospital, Institutional Review Board
Address
2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
| 2021 | Year | 09 | Month | 01 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2021 | Year | 08 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051592
