UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006447 |
|---|---|
| Receipt number | R000007614 |
| Scientific Title | Japanese Study of Visceral Adiposity and Lifestyle Information; Utilized and Evaluated 2 |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2012/10/30 09:25:19 |
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Basic information
Public title
Japanese Study of Visceral Adiposity and Lifestyle Information; Utilized and Evaluated 2
Acronym
J-VALUE2
Scientific Title
Japanese Study of Visceral Adiposity and Lifestyle Information; Utilized and Evaluated 2
Scientific Title:Acronym
J-VALUE2
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of visceral adiposity information and web-based weight loss program on waist circumference and body weight in overweight and obese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Waist circumference
Key secondary outcomes
Body weight, body mass index, visceral fat, life-style indices and/or those inprovements
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Web-based weight-loss program and information about visceral adiposity
Interventions/Control_2
Web-based weight-loss program
Interventions/Control_3
Control
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
BMI >= 23
Key exclusion criteria
1. Subjects who install medical equipments in body.
2. Subjects who are expecting pregnancy
3. Subjects who are considered inappropriate by medical doctors.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakane, Naoki |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Center
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi, Kyoto
TEL
075-641-9161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katashima, Mitsuhiro |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3, Bunka, Sumida, Tokyo
TEL
03-5630-7456
Homepage URL
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit 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
三井化学株式会社（本社、袖ヶ浦センター、市原工場、名古屋工場、岩国大竹工場、大牟田工場）健康管理室、住友金属工業株式会社鹿島製鉄所安全健康室、ホンダエンジニアリング株式会社健康管理センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
anthropometric measurements (waist circumrefence, body weight and BMI) were significantly decreased in VFA+web group (ANOVA p<0.05). Behavioral improvement (healthy eating and daily activity) were largest in VFA+web group. Anthropometric measurements were significantly decreased in web group. VFA+web was an effective waight loss program.
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 30 | Day |
Last modified on
| 2012 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007614
| Research Plan | |
|---|---|
| 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 |
