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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028592
Receipt No. R000032722
Scientific Title Effect of a short-term health tourism on body composition, energy metabolism and aerobic capacity
Date of disclosure of the study information 2017/08/09
Last modified on 2017/08/09

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Basic information
Public title Effect of a short-term health tourism on body composition, energy metabolism and aerobic capacity
Acronym A health tourism study
Scientific Title Effect of a short-term health tourism on body composition, energy metabolism and aerobic capacity
Scientific Title:Acronym A health tourism study
Region
Japan

Condition
Condition Adults overweight, obesity and healthy weight volunteer
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate effects of a health tourism on body composition, energy metabolism and aerobic capacity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight
Body composition
Energy metabolism
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Diet and Exercise
Interventions/Control_2
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Adult men and women, who were willing to lose body mass.
Key exclusion criteria Persons whose exercise is contraindicated by a doctor.
Pregnancy, lactation, and amenorrhea (absence of three or more consecutive menstrual cycles).
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Hiroaki
Organization Fukuoka University
Division name Faculty of Sports and Health Science
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka 814-0180, Japan.
TEL 092-871-6631(6767)
Email htanaka@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tanaka Hiroaki
Organization Fukuoka University
Division name Faculty of Sports and Health Science
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka 814-0180, Japan.
TEL 092-871-6631(6767)
Homepage URL http://www.fuipa.spo.fukuoka-u.ac.jp/
Email htanaka@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization Fukuoka 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
Address
Tel
Email

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
2017 Year 08 Month 09 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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032722

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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