UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050390
Receipt number R000057376
Scientific Title Relationship between body image and food products among female university students
Date of disclosure of the study information 2023/02/21
Last modified on 2023/02/20 17:01:29

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Basic information

Public title

Relationship between body image and food products among female university students

Acronym

Relationship between body image and food products among female university students

Scientific Title

Relationship between body image and food products among female university students

Scientific Title:Acronym

Relationship between body image and food products among female university students

Region

Japan


Condition

Condition

Distorted body image

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Aims to identify the impact of consuming foods perceived as "healthy" or "unhealthy" on body image and mood

Basic objectives2

Others

Basic objectives -Others

People's unconscious beliefs about healthy and unhealthy foods and their impact on body image will be revealed.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

figure rating scale

Key secondary outcomes

Body Image States Scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Food types

Interventions/Control_2

Food Calories

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

20 years-old >=

Gender

Female

Key inclusion criteria

Women in the first through fourth years of the Department of Health and Nutrition at the University will be recruited, and healthy female university students who agree with the content of the study and who decide to participate of their own free will will will be selected. Eating disorder patients will be excluded.

Key exclusion criteria

Voluntary participation

Target sample size

28


Research contact person

Name of lead principal investigator

1st name liulingzhi
Middle name Lingzhi
Last name liu

Organization

Niigata University of Health and Welfare

Division name

Health Science

Zip code

950-3198

Address

1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture

TEL

025-257-4455

Email

whm22003@nuhw.ac.jp


Public contact

Name of contact person

1st name inabahiromi
Middle name Hiromi
Last name Inaba

Organization

Niigata University of Health and Welfare

Division name

Health Science Discipline

Zip code

950-3198

Address

1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture

TEL

025-257-4455

Homepage URL


Email

inaba@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Health and Welfare

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University of Health and Welfare

Address

1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture

Tel

025-257-4455

Email

whm22003@nuhw.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

2023 Year 02 Month 21 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

2023 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2023 Year 05 Month 09 Day

Last follow-up date

2023 Year 08 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 02 Month 20 Day

Last modified on

2023 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057376


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name