UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041477
Receipt number R000047207
Scientific Title A study for effects of training with food on children's behavior associated with vegetable consumption
Date of disclosure of the study information 2020/09/29
Last modified on 2022/08/10 14:46:58

* 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 for effects of training with food on children's behavior associated with vegetable consumption

Acronym

A study for effects of training with food on children's behavior associated with vegetable consumption

Scientific Title

A study for effects of training with food on children's behavior associated with vegetable consumption

Scientific Title:Acronym

A study for effects of training with food on children's behavior associated with vegetable consumption

Region

Japan


Condition

Condition

N/A

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of food training on children's behaviors associated with vegetable consumption

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Children:
Self-efficacy for vegetable consumption,
Preference for vegetables

Key secondary outcomes

Children:
Reason for vegetable preferences, Eating experience, Consciousness about eating meals and vegetables, Neophobia, Vegetable consumption, Other change
Parents:
preference for Vegetables, Reason for vegetable preferences, Eating experience,
Vegetable consumption, Frequency of providing vegetables, Attitude towards children's food intake, Home food environment/annual income


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

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

Consumption of test food (4 weeks)

Interventions/Control_2

Training using test food (Quiz about vegetable, praise, etc.) (4 times)

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

3 years-old <=

Age-upper limit

6 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Children aged 3 to 6 and their parents at the start of the test
2)Among the children satisfying 1), those who don't like one or more of the 22 commonly eaten vegetables

Key exclusion criteria

1)Children with allergy for test food.
2)Those who may harm their health by eating vegetables

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shigenori
Middle name
Last name Suzuki

Organization

Kagome CO.,LTD.

Division name

Nature & Wellness Research Department

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Email

Shigenori.Suzuki@kagome.co.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name Mukuta

Organization

KAGOME CO., LTD.

Division name

Nature & Wellness Research Department

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Homepage URL


Email

Kei_Mukuta@kagome.co.jp


Sponsor or person

Institute

KAGOME CO., LTD.;Niigata University

Institute

Department

Personal name



Funding Source

Organization

KAGOME CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ritsumeikan university

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagome Research Ethics Committee

Address

3-21-1 Nihonbashi Hamacho, Tyuou, Tokyo

Tel

03-5623-8501

Email

Takuji_Hayakawa@kagome.co.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

新潟大学


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 29 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

2020 Year 08 Month 20 Day

Date of IRB

2020 Year 09 Month 21 Day

Anticipated trial start date

2020 Year 09 Month 30 Day

Last follow-up date

2021 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

2020 Year 08 Month 20 Day

Last modified on

2022 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name