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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001651
Receipt No. R000001989
Scientific Title The intervention study of 6 weeks behavior change coaching program in the way of one on one and a couple for people with metabolic syndrome
Date of disclosure of the study information 2009/01/22
Last modified on 2012/01/04

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Basic information
Public title The intervention study of 6 weeks behavior change coaching program in the way of one on one and a couple for people with metabolic syndrome
Acronym The intervention study of 6 weeks behavior change coaching program for people with metabolic syndrome
Scientific Title The intervention study of 6 weeks behavior change coaching program in the way of one on one and a couple for people with metabolic syndrome
Scientific Title:Acronym The intervention study of 6 weeks behavior change coaching program for people with metabolic syndrome
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of 6weeks coaching program for behavior modification
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Behavior for 6 weeks and the percentage of good behavior days (physical activity and diet),
2) Waist circumference, body weight, body mass index, blood pressure, fasting blood sugar, HDL cholesterol, triglyceride,
3) Self-rated health and psychological status for behavior change
Key secondary outcomes 1) Estimation of the program
2) Gamma-GTP,Total protein, albumin, GOT, GPT, Total cholesterol, Uric acid Blood urea nitrogen, Creatinine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 6weeks coaching program for behavior modification in the way of one on one
Interventions/Control_2 6weeks coaching program for behavior modification in the way of coupling
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
30 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Persons diagnosed with metabolic syndrome and their spouses

Criteria of Metabolic syndrome:
- Waist circumference: 85 cm or over for males, 90 cm or over for female plus positive at least 1 factors below.
1) the equal to or more than systolic blood pressure 130 and/or diastolic blood pressure 85 mmHg
2) above Triglyceride 150mg/dL or less than HDL-cholesterol 40mg/dL
3) above fasting blood sugar 110mg/dL
Key exclusion criteria Subjects prohibited exercise by medical physician
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuaki Goto
Organization Japan Health & Research Institute
Division name Research Department
Zip code
Address 1-29-4 NihonbashiKakigara Chuo-ku Tokyo
TEL 03-3668-1261
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kanase Toshiyuki
Organization Japan Health & Research Institute
Division name Research Department
Zip code
Address 1-29-4 NihonbashiKakigara Chuo-ku Tokyo
TEL 03-3668-1261
Homepage URL
Email kanase@jph-ri.or.jp

Sponsor
Institute Japan Health & Research Institute
Institute
Department

Funding Source
Organization Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Konami sports & Life
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
2009 Year 01 Month 22 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
2008 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 22 Day
Last modified on
2012 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001989

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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