UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038777
Receipt number R000043520
Scientific Title Beauty & healThy Project
Date of disclosure of the study information 2020/02/01
Last modified on 2021/04/26 15:27:10

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Basic information

Public title

Beauty & healThy Project

Acronym

BeauThy project

Scientific Title

Beauty & healThy Project

Scientific Title:Acronym

BeauThy project

Region

Japan


Condition

Condition

Normal weight obesity

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Develop an health educational program for those who are normal weight obesity to reduce body fat and validate the program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body fat rate

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Provide a health educational program

Interventions/Control_2

Provide existing information (conventional method)

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

People who fulfill all of the following requirements when they are registered.
1. 18.5 =< Body Mass Index (BMI)(Kg/m2) < 25
2. Body fat rate is over 20% (for male) or over 30% (for female).
3. Can communicate in Japanese fluently.
4. Can use an App, which use in the study.

Key exclusion criteria

People who do not meet one of following requirements when they are registered.
1. Under treat or have history of treating cardiovascular diseases, and doctors limit their movement because of the disease.
2. Under treat of Diabetes mellitus, kidney diseases, kidney disease, respiratory disease, orthopedic diseases, congenital diseases, neuromuscular diseases, and doctors limit their movement because of the disease.
3. The pregnant or people who might be during pregnancy.
4. Less than three months after the birth.
5. Had been registered other intervention for the purpose of reducing body fat(rate) or improving body composition.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Taku
Middle name
Last name Iwami

Organization

Kyoto university

Division name

Health Services

Zip code

6068501

Address

Yoshida-Honmachi, Sakyo-ku, Kyoto, JAPAN

TEL

+81757532401

Email

iwami.taku.8w@kyoto-u.ac.jp


Public contact

Name of contact person

1st name Manako
Middle name
Last name Konda

Organization

Kyoto university

Division name

School of public health, Department of preventive services

Zip code

6068501

Address

Yoshida-honmachi, Sakyo-ku, Kyoto, JAPAN

TEL

+81757532431

Homepage URL


Email

konda.manako.53v@st.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto university

Institute

Department

Personal name



Funding Source

Organization

Kyoto university

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

Kyoto university Graduate school and faculty of medicine, ethics committee

Address

Yoshida-konoecho, Sakyo-ku, Kyoto, JAPAN

Tel

+81757534680

Email

ethcom@kuhp.kyoto-u.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

2020 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


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

Enrolling by invitation

Date of protocol fixation

2019 Year 11 Month 27 Day

Date of IRB

2020 Year 01 Month 28 Day

Anticipated trial start date

2020 Year 09 Month 08 Day

Last follow-up date

2022 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

2019 Year 12 Month 03 Day

Last modified on

2021 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name