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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016892
Receipt No. R000019608
Scientific Title Saku Control Obesity Program
Date of disclosure of the study information 2015/03/25
Last modified on 2015/03/24

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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
Email 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
Email a-morita@koshien.ac.jp

Sponsor
Institute Incorporated Administrative Agency National Institute of Health and Nutrition
Institute
Department

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
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 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
URL(English) https://upload.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


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