UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052035 |
|---|---|
| Receipt number | R000057705 |
| Scientific Title | The nutrition education program for elementary school students and their guardians in Okinawa |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2024/06/25 09:28:47 |
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Basic information
Public title
The nutrition education program for elementary school students and their guardians in Okinawa
Acronym
Ginowan Kenko Project 2
Scientific Title
The nutrition education program for elementary school students and their guardians in Okinawa
Scientific Title:Acronym
Ginowan Kenko Project 2
Region
| Japan |
Condition
Condition
lifestyle-related disease
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of a 6-month video-based nutrition education program for elementary school students and their guardians on eating behavior and nutrition knowledge of elementary school students.
Basic objectives2
Others
Basic objectives -Others
To investigate the impact of a 6-month video-based nutrition education program for elementary school students and their guardians on dietary literacy and dietary habit behavior change of guardians.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in elementary school students' nutrition knowledge scores
Key secondary outcomes
1. Changes in the frequency of breakfast intake among elementary school students
2. Changes in solitary eating and eating with others at home among elementary school students
3. Changes in communication about food at home among elementary school students
4. Changes in obesity among elementary school students
5. Changes in the percentage of children who tend to be obese
6. Change in the percentage of children who tend to be thin
7. Change the amount of leftover school lunch
8. Changes in eating behavior of elementary school students
9. Changes in the indicators of the academic achievement survey of elementary school students
11. Changes in indicators of physical fitness of elementary school students
11. Changes in the dietary literacy scale for guardians
12. Changes in the frequency of breakfast intake by guardians
13. Changes in guardians ' dietary behavior change
14. Changes in communication about food at the home of guardians
15. Changes in body mass index (BMI) of guardians
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Video nutrition and health education (once every 1-2 weeks) will be provided to elementary school students and their parents in the intervention schools for six months. Questionnaires will be administered before and after the nutrition and health education to assess the effects on elementary school students' nutrition knowledge, eating habits, body size, academic achievement, physical fitness, parents' dietary literacy and behavioral change, and body size.
Interventions/Control_2
In the control groups, nutrition education classes in the regular school curriculum will be provided for elementary school students. Questionnaires will be administered before and after the nutrition and health education to assess the effects on elementary school students' nutrition knowledge, eating habits, body size, academic achievement, physical fitness, guardians' dietary literacy and behavioral change, body weight, and body mass index.
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
3rd to 5th graders (as of the 2023 school year) enrolled in the target elementary schools and their guardians
Key exclusion criteria
1. Elementary school students and their guardians who moved out during the study period
2. Elementary school students and their guardians who moved in during the study period
3. Elementary school students who were absent for an extended time during the study period and their guardians
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakima |
Organization
University of the Ryukyus
Division name
Health Administration Center
Zip code
903-0213
Address
Senbaru 1 Nishihara-cho, Okinawa, Japan
TEL
098-895-8144
asakima@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakima |
Organization
University of the Ryukyus
Division name
Health Administration Center
Zip code
903-0213
Address
Senbaru 1 Nishihara-cho, Okinawa, Japan
TEL
098-895-8144
Homepage URL
asakima@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Sakima Atsushi
Funding Source
Organization
Ginowan City, Okinawa Prefecture, Japan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of University of the Ryukyus for Medical and Health Research Involving Human Subjects
Address
Uehara 207 Nishihara-cho, Okinawa, Japan
Tel
098-895-1543
krinken@acs.u-ryukyu.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 | 09 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057705
