UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016892 |
|---|---|
| Receipt number | R000019608 |
| Scientific Title | Saku Control Obesity Program |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2015/03/24 12:25:32 |
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Basic information
Public title
Saku Control Obesity Program
Acronym
SCOP
Scientific Title
Saku Control Obesity Program
Scientific Title:Acronym
SCOP
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of lifestyle intervention (diet and exercise) on body weight reduction among obese people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Body mass index(BMI), height, percent body fat, weight circumference, visceral fat area, subcutaneous fat area, blood pressure, biochemical measurements (blood glucose, serum lipids, blood biomarkers, urine biomarkers), dietary intakes, eating behavior (appetite, taste), energy expenditure, basal metabolic rate, physical activity levels, personality inventory, and disease incidence
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lifestyle intervention (diet and exercise)
Interventions/Control_2
No intervention
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Underwent a medical checkup in the Saku Central Hospital since 2000.
2) Body mass index at the most recent visits greater than 28.3 kg/m2 (the upper five percentile of all examinees).
Key exclusion criteria
1) Psychiatric conditions that would preclude full participation in the study.
2) Physical conditions that would preclude full participation in the study (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke, and transient ischemic attacks).
3) Currently receiving treatment for obesity.
4) Currently receiving treatments known to affect eating behavior or weight.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shaw Watanabe |
Organization
Life Science Foundation
Division name
Life Science Foundation
Zip code
Address
25-3-1004 Daikyo-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-5379-7785
watashaw@lifescience.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akemi Morita |
Organization
Koshien University
Division name
Department of Nutrition
Zip code
Address
10-1 Momijigaoka, Takarazuka, Hyogo, Japan
TEL
0797-87-8078
Homepage URL
a-morita@koshien.ac.jp
Sponsor or person
Institute
Incorporated Administrative Agency National Institute of Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
佐久総合病院
Saku Central Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jaam/4/2/4_2_70/_pdf
Publication of results
Published
Result
URL related to results and publications
http://apjcn.nhri.org.tw/server/APJCN/21/1/22.pdf
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
Main results already published
Date of protocol fixation
| 2006 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019608
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
