UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050392 |
|---|---|
| Receipt number | R000056652 |
| Scientific Title | Effects of nutrition education using behavioral science theory in junior high school students ~Raising awareness of chronic kidney disease and fostering health literacy~ |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2026/03/11 14:36:47 |
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Basic information
Public title
Effects of nutrition education using behavioral science theory in junior high school students ~Raising awareness of chronic kidney disease and fostering health literacy~
Acronym
Effects of nutrition education using behavioral science theory in junior high school students
Scientific Title
Effects of nutrition education using behavioral science theory in junior high school students ~Raising awareness of chronic kidney disease and fostering health literacy~
Scientific Title:Acronym
Effects of nutrition education using behavioral science theory in junior high school students~Raising awareness of chronic kidney disease and fostering health literacy~
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the current level of awareness of CKD and its health-related knowledge, interests, and attitudes to second-year junior high school students and their parents.
Basic objectives2
Others
Basic objectives -Others
In addition, systematic nutrition education using leaflets will be conducted to foster health literacy and verify the ripple effect on parents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A questionnaire survey will be conducted after 11 months on changes in CKD awareness, changes in health literacy, and ripple effects on parents.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Questionnaire survey, 1 mock lesson, 6 educational materials distribution
Interventions/Control_2
Questionnaire survey, 6 educational materials distribution
Interventions/Control_3
Questionnaire survey
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
| 13 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
13 junior high schools in Sado City
Key exclusion criteria
When requested by one prefectural junior high school and the person's family
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | JUNKO |
| Middle name | |
| Last name | NAKAMURA |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata, 950-3198 JAPAN
TEL
025-257-4418
junko-nakamura@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | JUNKO |
| Middle name | |
| Last name | NAKAMURA |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata, 950-3198 JAPAN
TEL
025-257-4418
Homepage URL
junko-nakamura@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, niigata, 950-3198 JAPAN
Tel
025-257-4418
junko-nakamura@nuhw.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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
321
Results
The awareness of CKD before and after the intervention (1G, 2G, 3G) was 13.4%, 14.1%, and 10.4% for junior high school students (before and after) and 50.8%, 24.7%, and 16.9% for parents (before and after) parents (62.7%, 69.4%, 65.7% before; 71.2%, 68.8%, 67.8% after). The awareness of CKD increased in both parents and children in 1G. In addition, there was a significant association between CKD awareness and awareness of urinary protein in junior high school students in 1G and 2G (p=0.01).
Results date posted
| 2025 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were pairs of second-year junior high school students in City S and their parents. Schools were allocated to three groups: a class-based intervention group (n=107), a leaflet distribution group (n=114), and a control group (n=100). Group allocation was randomly conducted by the city board of education. Participation in the questionnaire survey was voluntary.
Participant flow
Pairs of second-year junior high school students and their parents in City S were included, and 13 schools participated in the study. Schools were allocated to three groups: a class plus leaflet group (107 pairs), a leaflet-only group (114 pairs), and a control group (100 pairs).
In the class plus leaflet group, 67 pairs responded to the first questionnaire and 59 pairs responded to the second questionnaire.
In the leaflet-only group, 86 pairs responded to the first questionnaire and 77 pairs responded to the second questionnaire.
In the control group, 67 pairs responded to the first questionnaire and 59 pairs responded to the second questionnaire.
The intervention consisted of one class session and leaflet distribution in the class plus leaflet group, leaflet distribution only in the leaflet group, and leaflet distribution after completion of the survey in the control group.
Adverse events
This study involved educational interventions (class session and leaflet distribution), and no adverse events related to the study were reported.
Outcome measures
Awareness of chronic kidney disease (CKD), assessed using a self-administered questionnaire before and after the intervention.
Awareness of CKD-related examination items (urinary protein and estimated glomerular filtration rate [eGFR]), assessed using a self-administered questionnaire after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056652
