UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034708 |
|---|---|
| Receipt number | R000039517 |
| Scientific Title | The Development of an Education Program to Reduce Salt Intake in Children |
| Date of disclosure of the study information | 2018/11/03 |
| Last modified on | 2024/11/03 13:26:08 |
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Basic information
Public title
The Development of an Education Program to Reduce Salt Intake in Children
Acronym
The Development of an Education Program to Reduce Salt Intake in Children
Scientific Title
The Development of an Education Program to Reduce Salt Intake in Children
Scientific Title:Acronym
The Development of an Education Program to Reduce Salt Intake in Children
Region
| Japan |
Condition
Condition
Elementary school students of 4th graders/5th graders/6th graders and their parent/guardian
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to develop and evaluate reduced salt diet among elementary school students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge retention of salt intake
Reduction of salt consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group A:Observe dietary salt intake, using the brief-type self-administered diet history questionnaire(BDHQ) +dietary salt intake was measured by urinary sodium excretion(early morning urine samples) +Quizzes on salt intake load.
After 3 weeks, deliver instruction on salt intake + Changing habits of salt intake.
After 2 weeks, observe, using the brief-type self-administered diet history questionnaire(BDHQ) -dietary salt intake was measured by urinary sodium excretion(early morning urine samples)
Interventions/Control_2
Group B:
Observe dietary salt intake, using the brief-type self-administered diet history questionnaire(BDHQ) +dietary salt intake was measured by urinary sodium excretion(early morning urine samples) +Quizzes on salt intake load.
After 5 weeks, observe, using the brief-type self-administered diet history questionnaire(BDHQ) +dietary salt intake was measured by urinary sodium excretion(early morning urine samples).Deliver instruction on how to reduce salt intake.
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
1.Students who are enrolled in elementary school in Aichi, Shizuoka, Kanagawa Prefecture.
2.Students and their guardians who have agreed to participate in the study
3.Those who participate in all areas of the study(survey)
4.Students who are accompanied by their parent or guardian.
Key exclusion criteria
Students and their parent or guardian who did not participate in all areas of survey
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kato |
Organization
KINJO GAKUIN UNIVERSITY
Division name
Department of Nursing
Zip code
463-8521
Address
2-1723,Omori,Moriyama-ku,Nagoya,Aichi
TEL
+81-52-798-0180
c-katoh@kinjo-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Kato |
Organization
KINJO GAKUIN UNIVERSITY
Division name
Department of Nursing
Zip code
463-8521
Address
2-1723,Omori,Moriyama-ku,Nagoya,Aichi
TEL
+81-52-798-0180
Homepage URL
c-katoh@kinjo-u.ac.jp
Sponsor or person
Institute
KINJO GAKUIN UNIVERSITY
Institute
Department
Personal name
Kato Chiaki
Funding Source
Organization
Japan Society for The Promotion Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu University School of Medicine
International University of health and welfare
Wayo Women's University
Name of secondary funder(s)
Japan Society for The Promotion Science
IRB Contact (For public release)
Organization
Ichinomiya Kenshin College
Address
5-4-1,Ogan-dori,Ichinomiya,Aichi
Tel
+81-0586-28-8110
c-katoh@kinjo-u.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
西尾市立小学校、一宮市立小学校、常葉大学教育学部附属小学校
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 03 | 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
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039517
