UMIN-CTR Clinical Trial

Basic information
Public title	Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students
Acronym	Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students
Scientific Title	Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students
Scientific Title:Acronym	Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students
Region	Japan

Condition
Condition	normal weight obesity
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Develop a health education program for normal weight obese people to reduce their body fat rate, and verify its effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changing in body fat rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Offering the health education program
Interventions/Control_2	Offering information (as same as current correspondence)
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	1. Meet the normal weight obesity criteria. (Male: 18.5 =< BMI (kg/m2) < 25 and body fat rate (%) >= 20 Female: 18.5 =< BMI (kg/m2) < 25 and body fat rate (%) >= 30) 2. Fluent in Japanese. 3. Capable to use smart phone application.
Key exclusion criteria	1. Under treatment or have history of cardiovascular diseases and limited ones' physical activity by doctors. 2. Under treatment of diabetes mellitus, kidney diseases, respiratory diseases, orthopedic diseases, congenital diseases, neuromuscular disease and limited ones' physical activity by doctors. 3. The period of pregnancy or have possibility of it. 4. Within three months of childbirth. 5. Participants of intervention programs to reduce body fat rate or to improve 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	Agency for Health, Safety and Environment
Zip code	606-8501
Address	Yoshidahon-machi, Sakyo-ku, Kyoto
TEL	075-753-2401
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	606-8501
Address	Yoshidahon-machi, Sakyo-ku, Kyoto
TEL	075-753-2431
Homepage URL
Email	konda.manako.53v@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	The Cardiovascular Research Fund (Tokyo, JAPAN)
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 Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
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 05 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 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 03 Month 17 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045175

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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