UMIN-CTR Clinical Trial

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
Institute	Kyoto university
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043520