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 2023/08/02 17:15:59

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 30 Day

Last modified on

2023 Year 08 Month 02 Day



Link to view the page

Value
https://center6.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