UMIN-CTR Clinical Trial

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
Email	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
Email	hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute	Department of psychosomatic medicine, Kansai Medical University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051592