UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055383 |
|---|---|
| Receipt number | R000063290 |
| Scientific Title | Development and verification of a Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/03/04 20:39:41 |
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Basic information
Public title
Development and verification of a Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system
Acronym
Development and verification of Shokuiku (Food and Nutrition Education) radio broadcasts
Scientific Title
Development and verification of a Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system
Scientific Title:Acronym
Development and verification of Shokuiku (Food and Nutrition Education) radio broadcasts
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify points 1) and 2) by conducting an intervention using the school public address system, focusing on conversations and voluntary mealtime communication during school lunch time among children.
1) Develop a Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system and clarify whether it can be used for nutrition education in elementary school children.
2) To clarify the effect of a Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system on conversations and voluntary mealtime communication during school lunch time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Voluntary mealtime communication immediately after the end of the intervention, and 1 and 3 months later
Key secondary outcomes
Immediately after the end of the intervention, and 1 and 3 months later, mealtime enjoyment, voluntary mealtime communication at home, and satisfaction with the Shokuiku (Food and Nutrition Education) program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During lunch time, students will participate in an intervention Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system once a week for one month while eating their school lunch.
Interventions/Control_2
During lunch time, students will participate in a general Shokuiku (Food and Nutrition Education) program delivered via radio broadcasts using the school public address system once a week for one month while eating their school lunch.
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
| 9 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
4th, 5th, and 6th grade elementary school students
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yoshiike |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Science
Zip code
030-8505
Address
58-1, Mase, Hamadate, Aomori City, Aomori, Japan
TEL
017-765-2100
n_yoshiike@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Yoshida |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Science
Zip code
030-8505
Address
58-1, Mase, Hamadate, Aomori City, Aomori, Japan
TEL
017-765-2100
Homepage URL
2391010@ms.auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Aomori University of Health and Welfare
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
Aomori University of Health and Welfare
Address
58-1, Mase, Hamadate, Aomori City, Aomori, Japan
Tel
017-765-2000
rinri2008@auhw.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
| 2024 | Year | 08 | Month | 30 | 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
| 2024 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063290
