UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052828 |
|---|---|
| Receipt number | R000060294 |
| Scientific Title | Project to improve skipping breakfast for university students (impact of video streaming on skipping breakfast of university students) |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2024/02/16 09:51:34 |
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Basic information
Public title
Carbon neutral by eating habits! -A well-balanced diet starts with breakfast!-
Acronym
Carbon neutral by eating habits! -A well-balanced diet starts with breakfast!-
Scientific Title
Project to improve skipping breakfast for university students (impact of video streaming on skipping breakfast of university students)
Scientific Title:Acronym
Project to improve skipping breakfast for university students (impact of video streaming on skipping breakfast of university students)
Region
| Japan |
Condition
Condition
Lifestyle-related disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to determine whether the breakfast intake rate, eating habits, and attitudes of undergraduate and graduate students can be improved by posting posters and distributing a video encouraging breakfast intake once a month through the university portal site.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breakfast intake rate, eating habits, and attitudes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Posting posters and distributing a video encouraging breakfast intake once a month through the university portal site
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
| 19 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
First to 3rd year university students and 1st year graduate students at the start of the research
Key exclusion criteria
At least a senior in college or a sophomore in graduate school at the start of the research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kibayashi |
Organization
Sonoda Women's University
Division name
Department of Food and Nutrition
Zip code
661-8520
Address
7-29-1 Minami-Tsukaguchi-cho, Amagasaki City, Hyogo Prefecture
TEL
06-6429-1201
K22019@sonoda-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kibayashi |
Organization
Sonoda Women's University
Division name
Department of Food and Nutrition
Zip code
661-8520
Address
7-29-1 Minami-Tsukaguchi-cho, Amagasaki City, Hyogo Prefecture
TEL
06-6429-1201
Homepage URL
K22019@sonoda-u.ac.jp
Sponsor or person
Institute
Sonoda Women's University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Dietetic Association
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
University of Hyogo
Address
1-1-12 Shinzaike-Honmachi, Himeji, Hyogo
Tel
079-292-9334
nakade@shse.u-hyogo.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
| 2023 | Year | 11 | Month | 17 | 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
100
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
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 16 | 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 | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
