UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022356 |
|---|---|
| Receipt number | 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 | 2023/11/28 18:47:20 |
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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
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
t-onoue@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025770
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
