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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039847
Receipt No. R000045175
Scientific Title Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students
Date of disclosure of the study information 2020/05/01
Last modified on 2020/09/25

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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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