UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054554
Receipt number R000062332
Scientific Title A Study of Food Environments that Promote Sustainable and Healthy Food Choices -An Empirical Study in Local Restaurants-
Date of disclosure of the study information 2024/06/05
Last modified on 2024/12/02 10:29:51

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Basic information

Public title

A Study of Food Environments that Promote Sustainable and Healthy Food Choices
-An Empirical Study in Local Restaurants-

Acronym

Study of Food Environments Promoting Sustainable and Healthy Food Choices

Scientific Title

A Study of Food Environments that Promote Sustainable and Healthy Food Choices
-An Empirical Study in Local Restaurants-

Scientific Title:Acronym

Study of Food Environments Promoting Sustainable and Healthy Food Choices

Region

Japan


Condition

Condition

Lifestyle diseases

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To promote sustainable and healthy food choices for users by creating a food environment in local restaurants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Food choice

Key secondary outcomes

Dietary knowledge, attitudes, and behaviors


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

Food Behavior,custom

Interventions/Control_1

Food environment improvement

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Restaurant users

Key exclusion criteria

No reply

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Fumi
Middle name
Last name Hayashi

Organization

Kagawa Nutrition University

Division name

Nutrition Ecology

Zip code

350-0288

Address

3-9-21 Chiyoda Sakado-shi Saitama

TEL

049-282-3721

Email

hayashi.fumi@eiyo.ac.jp


Public contact

Name of contact person

1st name Fumi
Middle name
Last name Hayashi

Organization

Kagawa Nutrition University

Division name

Nutrition Ecology

Zip code

350-0288

Address

3-9-21 Chiyoda Sakado-shi Saitama

TEL

049-282-3721

Homepage URL


Email

hayashi.fumi@eiyo.ac.jp


Sponsor or person

Institute

Kagawa Nutrition University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethical Committee of Kagawa Nutrition University

Address

3-9-21 Chiyoda Sakado-shi Saitama

Tel

049-282-1353

Email

kenshien@eiyo.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 06 Month 05 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

Completed

Date of protocol fixation

2024 Year 05 Month 08 Day

Date of IRB

2024 Year 05 Month 15 Day

Anticipated trial start date

2024 Year 06 Month 05 Day

Last follow-up date

2026 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 06 Month 03 Day

Last modified on

2024 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062332