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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022356
Receipt No. R000025770
Scientific Title Study of the effectiveness of the 12-week weight loss program based on measurement of energy expenditure
Date of disclosure of the study information 2016/06/01
Last modified on 2020/04/28

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Basic information
Public title Study of the effectiveness of the 12-week weight loss program based on measurement of energy expenditure
Acronym Study of the effectiveness of the 12-week weight loss program based on measurement of energy expenditure
Scientific Title Study of the effectiveness of the 12-week weight loss program based on measurement of energy expenditure
Scientific Title:Acronym Study of the effectiveness of the 12-week weight loss program based on measurement of energy expenditure
Region
Japan

Condition
Condition obesity
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Calculation method in consideration with the energy required amount of individual differences in the treatment of obesity was not established yet. In this study, we design 12-week weight loss program that performs the energy requirement calculation based on energy consumption, and examine its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes weight loss at the end of the program (12 weeks after initial intervention).
Key secondary outcomes Changes of resting energy expenditure during weight loss.
Change of body composition.
Change of serum leptin level and hunger feeling.
Presence or absence of BW rebound 3 month after the program.

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Nutritional guidance based on the measurement of resting energy expenditure and the amount of activity (before, 2w, 4w, 8w, 12w). Intervention periods; 12weeks.
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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria BMI > 30
Without serious major organ problems
Who written consent has been obtained
Key exclusion criteria A person who has cancer, a serious underlying disease such as chronic inflammatory diseases currently.
Diabetic patients in the insulin treatment.
Who the doctor has determined that improper participation.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Arima
Organization Nagoya University Graduate School of Medicine
Division name Endocrinology and Diabetes
Zip code 466-0065
Address 65 Tsurumai-Cho, Showa-ku, Nagoya, Japan
TEL 0527442142
Email arima105@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Onoue
Organization Nagoya University Graduate School of Medicine
Division name Endocrinology and Diabetes
Zip code 466-0065
Address 65 Tsurumai-Cho, Showa-ku, Nagoya, Japan
TEL 0527442142
Homepage URL
Email t-onoue@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine
Address 65 Tsurumai-Cho, Showa-ku, Nagoya, Japan
Tel 052-744-2881
Email ethics@med.nagoya-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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 06 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
2016 Year 05 Month 19 Day
Date of IRB
2016 Year 07 Month 19 Day
Anticipated trial start date
2017 Year 04 Month 01 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
2016 Year 05 Month 19 Day
Last modified on
2020 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025770

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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