UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055798 |
|---|---|
| Receipt number | R000063773 |
| Scientific Title | Nutrition education with elements of chrono-nutrition in an elementary school |
| Date of disclosure of the study information | 2024/10/09 |
| Last modified on | 2024/10/09 19:35:38 |
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Basic information
Public title
Nutrition education with elements of chrono-nutrition in an elementary school
Acronym
Nutrition education with elements of chrono-nutrition
Scientific Title
Nutrition education with elements of chrono-nutrition in an elementary school
Scientific Title:Acronym
Nutrition education with elements of chrono-nutrition in an elementary school
Region
| Japan |
Condition
Condition
School children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct nutrition education classes incorporating elements of chrono-nutrition for elementary school students, and evaluate the effectiveness of the classes in terms of children's knowledge, awareness, and lifestyle. In addition, class evaluations will be conducted by teachers who observe the classes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge
Consciousness of healthy life style
Attitude (willingness to improve lifestyle)
Lifestyle (breakfast, sleep, electronic device use during night)
Key secondary outcomes
Evaluation items for classes and teaching materials
(e.g., is it relevant to the grade level and interests of the children?)
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
Self check of lifestyle
Nutrition education class (single session)
Self-monitoring
Individual feedback for children
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
| 9 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Elementary school students
2) Fourth grade (ages 9-10)
Key exclusion criteria
1) Children who are absent on a class day
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
TEL
+81-79-292-1515
nagai.lab.uh@gmail.com
Public contact
Name of contact person
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
TEL
+81-79-292-1515
Homepage URL
nagai.lab.uh@gmail.com
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The SHSE (School of Human Science and Environment) Research Ethics Committee of the University of Hyogo
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
Tel
+81-79-292-1515
u_hyogo_kankyou@ofc.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
| 2024 | Year | 10 | Month | 09 | 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
97
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063773
