UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042949
Receipt number R000049024
Scientific Title A pilot study to examine the effect of remote nutrition education on the Japan Diet
Date of disclosure of the study information 2021/02/01
Last modified on 2024/01/11 23:12:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study to examine the effect of remote nutrition education on the Japan Diet

Acronym

Remote nutrition education study on the Japan Diet

Scientific Title

A pilot study to examine the effect of remote nutrition education on the Japan Diet

Scientific Title:Acronym

Remote nutrition education study on the JD

Region

Japan


Condition

Condition

overweight

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of remote nutrition education on the Japan Diet intake using teaching materials which ameliorate predisposing and enabling factors of dieting practice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Increase the Japan Diet pattern score at 3month.

Key secondary outcomes

Body weight decrease or improve serum biochemical parameters


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

Behavior,custom

Interventions/Control_1

Face to face internet nutrition counseling will be done at baseline, after 1 and 2 month.

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

22 years-old <=

Age-upper limit

39 years-old >

Gender

Male

Key inclusion criteria

BMI>22
Recommended by a study doctor

Key exclusion criteria

1.Smoker, quit smoking less than 6 months
2.Habitual supplement and/or health food user
3.Practicing clinical diet therapy
4.Under medication
5. Live in different dietary environment during intervention

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Chizuko
Middle name
Last name Maruyama

Organization

Japan Women's University

Division name

Department of Food and Nutrition

Zip code

112-8681

Address

2-8-1, Mejirodai, Bunkyo-ku, Tokyo

TEL

03-5981-3428

Email

maruyama@fc.jwu.ac.jp


Public contact

Name of contact person

1st name Chizuko
Middle name
Last name Maruyama

Organization

Japan Women's University

Division name

Department of Food and Nutrition

Zip code

112-8681

Address

2-8-1, Mejirodai, Bunkyo-ku, Tokyo

TEL

03-5981-3428

Homepage URL


Email

maruyama@fc.jwu.ac.jp


Sponsor or person

Institute

Laboratory of Nutrition Education and Clinical nutrition in Japan Women's University

Institute

Department

Personal name



Funding Source

Organization

Rice Stable Supply Support Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee for Experimental Research involving Human Subjects of Japan Women's University

Address

2-8-1, Mejirodai, Bunkyo-ku, Tokyo

Tel

03-5981-3773

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

2021 Year 02 Month 01 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

39

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

No longer recruiting

Date of protocol fixation

2020 Year 11 Month 30 Day

Date of IRB

2020 Year 12 Month 21 Day

Anticipated trial start date

2021 Year 02 Month 08 Day

Last follow-up date

2021 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 12 Month 30 Day


Other

Other related information



Management information

Registered date

2021 Year 01 Month 08 Day

Last modified on

2024 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name