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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034708
Receipt No. R000039517
Official scientific title of the study 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 2018/10/30

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Basic information
Official scientific title of the study The Development of an Education Program to Reduce Salt Intake in Children
Title of the study (Brief title) 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 100

Research contact person
Name of lead principal investigator Chiaki Kato
Organization Tokoha University
Division name Facalty of Health Science Child Nursing
Address 1-30,Mizuoc, Aoi, Shizuoka, Shizuoka
TEL +81-054-297-3200
Email c-kato@sz.tokoha-u.ac.jp

Public contact
Name of contact person Chiaki Kato
Organization Tokoha University
Division name Facalty of Health Science Child Nursing
Address 1-30,Mizuoc, Aoi, Shizuoka, Shizuoka
TEL +81-054-297-3200
Homepage URL
Email c-kato@sz.tokoha-u.ac.jp

Sponsor
Institute Tokoha University Facalty of Health Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 11 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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