UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054856
Receipt number R000062680
Scientific Title Dietary education, "Shokuiku", for child inpatients using digital tools - Investigation of the possibilities and challenges of "Shokuiku" instruction using ICT (Information and Communication Technology)
Date of disclosure of the study information 2024/07/02
Last modified on 2025/01/16 12:39:21

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Basic information

Public title

Dietary education, "Shokuiku", for child inpatients using digital tools - Investigation of the possibilities and challenges of "Shokuiku" using ICT (Information and Communication Technology)

Acronym

Dietary education, "Shokuiku", for child inpatients using digital tools

Scientific Title

Dietary education, "Shokuiku", for child inpatients using digital tools - Investigation of the possibilities and challenges of "Shokuiku" instruction using ICT (Information and Communication Technology)

Scientific Title:Acronym

Dietary education, "Shokuiku", for child inpatients using digital tools

Region

Japan


Condition

Condition

Pediatric inpatients

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Explore the possibilities and problems of online dietary education using digital tools for pediatric inpatients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Children's health consciousness of food

Key secondary outcomes

Parental satisfaction with "Shokuiku"


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Watch video

Interventions/Control_2


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

4 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

Pediatric long-term inpatients, mainly school-aged

Key exclusion criteria

Patients with short hospital stays, Patients who do not consent

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Tsuji

Organization

Kyoto Women's University

Division name

Department of Food and Nutrition

Zip code

605-8501

Address

35 Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto

TEL

075-531-7153

Email

tsujima@kyoto-wu.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Tsuji

Organization

Kyoto Women's University

Division name

Department of Food and Nutrition

Zip code

605-8501

Address

35 Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto

TEL

075-531-7153

Homepage URL


Email

tsujima@kyoto-wu.ac.jp


Sponsor or person

Institute

Kyoto Women's University

Institute

Department

Personal name



Funding Source

Organization

Kyoto Women's University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyoto University Hospital, Hyogo Prefectural Amagasaki General Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Women's University

Address

35 Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto

Tel

075-531-6232

Email

kenkyukikaku@kyoto-wu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

C1596

Org. issuing International ID_1

Kyoto University Hospital

Study ID_2

3-81

Org. issuing International ID_2

Hyogo Prefectural Amagasaki General Medical Center

IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2024 Year 07 Month 02 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

2022 Year 06 Month 21 Day

Date of IRB

2021 Year 08 Month 03 Day

Anticipated trial start date

2024 Year 07 Month 15 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

2024 Year 07 Month 02 Day

Last modified on

2025 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062680