UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008560 |
|---|---|
| Receipt number | R000010061 |
| Scientific Title | Randomized Controlled trial to assess effectiveness of a lifestyle education program based on a personal support for Metabolic Syndrome ( PSMetS) |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2016/01/30 22:09:48 |
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Basic information
Public title
Randomized Controlled trial to assess effectiveness of a lifestyle education program based on a personal support for Metabolic Syndrome ( PSMetS)
Acronym
Evaluation of PSMetS Program Based on RCT
Scientific Title
Randomized Controlled trial to assess effectiveness of a lifestyle education program based on a personal support for Metabolic Syndrome ( PSMetS)
Scientific Title:Acronym
Evaluation of PSMetS Program Based on RCT
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of lifestyle education program based on a personal support for reducing number of risk factors of metabolic syndrome in Japanese male workers through a randomized controled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of risk factors related to metabolic syndrome at 1 year
Key secondary outcomes
(Changes between baseline and 1year)
waist circumference,
Body Mass Index(BMI),FPG,TG, HDL-C, SBP,DBP,dietary intakes(energy and nutrients),etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
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
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
To conduct 9 months tailor-made counseling on lifestyle modification program for improvement of metabolic syndrome by registered dietitian.
Interventions/Control_2
Bring back an assessment sheet for FFQW82 along with advise as a standard counseling on lifestyle modification by medical doctor/nurse
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
| 25 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Persons having special health check-up and who have one or two more risks (a-d) in addition to waist circumference condition (>=85cm), Active support: risk>=2, Motivation support: risk>=1
2. Persons having special health check-up and who have one or two more risks (a-d) in addition to waist circumference condition (>=85cm)
3. Risks:
a: Blood sugar level(FBS>=100mg/dl or HbA1c>=5.2%)
b: Lipid level (TG>=150mg/dl or HDL<40mg/dl)
c: Hypertension (SBP>=130mmHg or DBP>=85mmHg
d: Smoking habit only when having risks of(a or b or c)
Key exclusion criteria
1. Persons who did not obtained informed consent.
2. Persons with CHD
3. Persons to whom a medication is newly begun (<3 months) for diabetes, hypertension, or a lipid metabolic aberration)
4. Persons who has no clinical data.
5. Persons who has no FFQW82 data.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Watanabe |
Organization
Showa Women's University
Division name
Department of Human Nutrition, Graduate School of Human Ecology
Zip code
Address
1-7-57 Taishido, Setagaya, Tokyo 154-8533, Japan
TEL
03-3411-6591
ebn.mariko@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MASAKO YOKOTUKA |
Organization
Showa Women's University
Division name
Department of Nutrition and Health Promotion
Zip code
Address
1-7-57 Taishido, Setagaya, Tokyo 154-8533, Japan
TEL
03-3411-6237
Homepage URL
myoko@swu.ac.jp
Sponsor or person
Institute
Study Group of Evaluation PSMetS Program Based on RCT
Mariko Watanabe, Kazue Yamaoka,Toshiro Tango, Misa Adachi, Masako Yokotuka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010061
| 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 |
