UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041319 |
|---|---|
| Receipt number | R000047183 |
| Scientific Title | Development and evaluation of tools for improving breakfast habits and health awareness of univ. students |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2021/02/04 11:59:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and evaluation of tools for improving breakfast habits and health awareness of univ. students
Acronym
Development and evaluation of tools for improving breakfast habits of univ. students
Scientific Title
Development and evaluation of tools for improving breakfast habits and health awareness of univ. students
Scientific Title:Acronym
Development and evaluation of tools for improving breakfast habits of univ. students
Region
| Japan |
Condition
Condition
Dietary habit
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and evaluation of a tool improving breakfast habit
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in breakfast frequency and breakfast content
Key secondary outcomes
QOL
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Reporting conditions of breakfast for 28 days.
Give a feedback each other among groups.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
University students
Living in Sapporo city
Key exclusion criteria
Not university students
Not living in Sapporo city
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | Yamauchi |
| Last name | Yamauchi |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Division of Health Sciences
Zip code
0600812
Address
N12, W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063379
taroy@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Yamauchi |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Division of Health Sciences
Zip code
060-0812
Address
N12, W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063379
Homepage URL
taroy@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Hokkaido University
Address
N12, W5, Kita-ku, Sapporo, Hokkaido
Tel
0117063379
taroy@med.hokudai.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
| 2020 | Year | 09 | Month | 15 | 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
30
Results
Intervention result
1. Breakfast intake frequency by breakfast habit before intervention
Almost every day
maintained:100%
Four or five days a week
maintained or increased:67%
Two or third days a week
increased:100%
Rarely
increased:100%
2. Breakfast quality
Almost every day
maintained or increased:60%
decreased:40%
Four or five days a week
increased:50%
decreased:50%
Two or third days a week
increased:80%
decreased:20%
Rarely
increased:89%
decreased:11%
Results date posted
| 2021 | Year | 02 | Month | 04 | Day |
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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
