UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051157 |
|---|---|
| Receipt number | R000058341 |
| Scientific Title | Effectiveness of a combined educatinnal program on nutrition and physical activity for elementaly students using the "3 1 2 Meal Box Magic" |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2023/05/24 17:05:33 |
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Basic information
Public title
Effectiveness of a combined educatinnal program on nutrition and physical activity for elementaly students using the "3 1 2 Meal Box Magic"
Acronym
Effectiveness of a combined educatinnal program on nutrition and physical activity for elementaly students using the "3 1 2 Meal Box Magic"
Scientific Title
Effectiveness of a combined educatinnal program on nutrition and physical activity for elementaly students using the "3 1 2 Meal Box Magic"
Scientific Title:Acronym
Effectiveness of a combined educatinnal program on nutrition and physical activity for elementaly students using the "3 1 2 Meal Box Magic"
Region
| Japan |
Condition
Condition
Healthy Children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is examine a combined educational program on nutrition and physical activity for elementary students using the "3 1 2 Meal Box Magic"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of completing school lunch
Enjoying a school lunch
Survey period:pre-survey, post-survey
Key secondary outcomes
Self-efficacy regarding well-balanced of school lunch
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will be educated about "3 1 2 Meal Box Magic Method"
Interventions/Control_2
The control group will not be educated about "3 1 2 Meal Box Magic Method"
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
| 10 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The students who are enrolled at elementaly schools in Saitama and Kasukabe prefectures
2.The students and their parents/guardian who have agreed to participate in this study
3.The participants who attend all the survey
Key exclusion criteria
1.The students who are continuously absent form school due to school refusal etc.
2.The students who are difficult to participate the survey due to health reasons
3.Those who do not have sufficient ability in Japanese to participate in this survey
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Matsushita |
Organization
Kagawa Nutrition University
Division name
Undergraduate School of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
TEL
049-284-3582
mkayo@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Matsushita |
Organization
Kagawa Nutrition University
Division name
Undergraduate School of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
TEL
049-284-3582
Homepage URL
mkayo@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Nutrition 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
Kagawa Nutrition University Research Reviw Committee
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
Tel
049-289-6041
kenshien@eiyo.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
| 2023 | Year | 05 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | 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
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058341
