UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054989
Receipt number R000062828
Scientific Title The impact of visualizing diet quality on dietary habit of university students
Date of disclosure of the study information 2024/07/18
Last modified on 2024/07/17 09:46:45

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Basic information

Public title

The impact of education using diet quality score on university students' dietary improvements

Acronym

Effects of visualizing diet quality

Scientific Title

The impact of visualizing diet quality on dietary habit of university students

Scientific Title:Acronym

Effects of visualizing diet quality

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to test the hypothesis that knowing the diet quality can be visualized numerically, which will have a positive effect on dietary habits.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare the changes in Nutrient-Rich Food Index 9.3 (NRF9.3) scores of diet before and after the intervention between groups

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: Using a menu catalog that specifies the NRF9.3 score to indicate diet quality, we will explain and help participants understand the specific differences
between high-scoring and low-scoring meals. After this explanation, participants will be asked to set three goals for healthier eating and adhere to them for one week.

Interventions/Control_2

Control group: From the information they usually obtain, list three goals for a healthier diet and adhere to them for one week

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

University students

Key exclusion criteria

- Those who are unable to change their diet due to environmental constraints (such as having meals determined by a dormitory every day).
- Those who possess specialized knowledge of nutrition.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Sato

Organization

Japan Women's University

Division name

Dept. of Food and Nutrition, Faculty of Human Sciences and Design

Zip code

1128681

Address

2-8-1, Mejirodai, Bunkyo-ku

TEL

81-3-5981-3441

Email

saton@fc.jwu.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Sato

Organization

Japan Women's University

Division name

Dept. of Food and Nutrition, Faculty of Human Sciences and Design

Zip code

1128681

Address

2-8-1, Mejirodai, Bunkyo-ku

TEL

81-3-5981-3441

Homepage URL


Email

saton@fc.jwu.ac.jp


Sponsor or person

Institute

Japan Women's Univiersity

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

Graduate School of Health Care Sciences, Tokyo Medical and Dental University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical committee for experimental research involving human subjects, Japan Women's Univerisyt

Address

2-8-1, Mejirodai, Bunkyo-ku

Tel

81-3-5981-3775

Email

n-shien@atlas.jwu.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

2024 Year 07 Month 18 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

Preinitiation

Date of protocol fixation

2024 Year 05 Month 31 Day

Date of IRB

2024 Year 06 Month 25 Day

Anticipated trial start date

2024 Year 07 Month 22 Day

Last follow-up date

2024 Year 12 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 17 Day

Last modified on

2024 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name