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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008560
Receipt No. 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

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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
Email 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
Email myoko@swu.ac.jp

Sponsor
Institute Study Group of Evaluation PSMetS Program Based on RCT
Mariko Watanabe, Kazue Yamaoka,Toshiro Tango, Misa Adachi, Masako Yokotuka




Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010061

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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