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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039062
Receipt No. 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

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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
Email 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
Email n-kimura@rakuno.ac.jp

Sponsor
Institute Rakuno Gakuen University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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