UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039062 |
|---|---|
| Receipt number | R000044548 |
| Scientific Title | Reasons for skipping breakfast among senior high school students living in a dormitory and the effects of nutrition education in a short time |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2020/07/07 09:10:04 |
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Basic information
Public title
Reasons for skipping breakfast among senior high school students living in a dormitory and the effects of nutrition education in a short time
Acronym
Reasons for skipping breakfast among students and the effects of nutrition education
Scientific Title
Reasons for skipping breakfast among senior high school students living in a dormitory and the effects of nutrition education in a short time
Scientific Title:Acronym
Reasons for skipping breakfast among students and the effects of nutrition education
Region
| Japan |
Condition
Condition
Teenagers who may skip breakfast
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to understand why senior high school students living in a dormitory skip breakfast. We will also clarify the effect of nutrition education on skipping breakfast in a short time period for the students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: We will assess the effect of nutrition education by asking students to complete questionnaires before and after one nutrition education session. An index of the assessment is the change in the breakfast skipping rate.
Key secondary outcomes
Secondary outcome: The first index of the assessment is whether or not the students have motivation to eat breakfast. The second index of the assessment is changes made to the reasons for skipping and eating breakfast. The third index is whether or not the students understand the importance of breakfast. The fourth index is whether the students gain knowledge regarding breakfast.
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
Intervention period: January 13-14, 2020.
Number of interventions: We will provide nutrition education for the students once. We will send out a questionnaire before and after the nutrition education.
Target of intervention: Seventy senior high school students (grades 1-3).
Place of intervention: Christianity Independence Senior High School (a boarding school).
Intervention plan: On the morning of the first day, we will administer a questionnaire to the students. The questionnaire takes 5 minutes to complete. The same afternoon, we will provide nutrition education based on the questionnaire in each school grade in the classroom for 10 minutes.
On the morning of the second day, we will administer a questionnaire to each school grade classroom. The questionnaire takes 5 minutes to complete. Using this second questionnaire, we will assess the effect of the nutrition education that we provided the previous day.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All Christianity Independence Senior High School students are eligible.
Key exclusion criteria
Students who refuse to cooperate with our intervention are excluded from the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Nobuya |
| Middle name | |
| Last name | Kimura |
Organization
Rakuno Gakuen University
Division name
Department of Food Science and Human Wellness
Zip code
069-8501
Address
582, Bunkyodai-Midorimachi,Ebetsu,Hokkaido 069-8501,Japan
TEL
011-388-4603
n-kimura@rakuno.ac.jp
Public contact
Name of contact person
| 1st name | Nobuya |
| Middle name | |
| Last name | Kimura |
Organization
Rakuno Gakuen University
Division name
Department of Food Science and Human Wellness
Zip code
069-8501
Address
582, Bunkyodai-Midorimachi,Ebetsu,Hokkaido 069-8501,Japan
TEL
011-388-4603
Homepage URL
n-kimura@rakuno.ac.jp
Sponsor or person
Institute
Rakuno Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Rakuno Gakuen University
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
Research Ethics Committee of the Rakuno Gakuen University
Address
582, Bunkyodai-Midorimachi,Ebetsu,Hokkaido 069-8501,Japan
Tel
011-388-4128
rg-gakum@rakuno.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 | 01 | Month | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 14 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044548
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