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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students |
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Acronym | Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students |
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Scientific Title | Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students |
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Scientific Title:Acronym | Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students |
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Region |
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Condition | ||
Condition | normal weight obesity | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
iwami.taku.8w@kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |