UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effects of a worksite-based simple weight reduction program:cross over trial and 1 year follow up study
Title of the study (Brief title)	effects of a worksite-based weight reduction program
Region	Japan

Condition
Condition	obsesity men with risk factors of metabolic syndrome
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we examine the effects of a worksite-based simple weight reduction program among Japanese men with cardiovascular risk factors.
Basic objectives2	Others
Basic objectives -Others	we examine the effects of a worksite-based simple weight reduction program. We also observed weight loss maintacance during 1 year follow-up.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	weight waist(0,1.5M,3M,4.5M, 6M, 7.5M 15M, 18M)
Key secondary outcomes	SBP, DBP, TChol, HDL-C, LDL-C, FBS HbA1c(0,1.5M,3M,4.5M, 6M, 7.5M 15M, 18M)

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	intervention group 3 month weight redction program (2 group session, approximately 60-90 minutes by Physicians and 4 individual lifestyle counseling sessions, approximately 15 minutes by Public health nurses) 1 year follow up study after this weight rection program.
Interventions/Control_2	conrol group After interventioin group recieve the 3month weight redction program, the control group receive the same program. 1 year follow up study after this weight rection program.
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	19 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	1) were aged 19 to 60 years, 2) had a body mass index (BMI) of 25 kg/m2 or higher, 3) had received physician approval for study participation, and 4) had one or more of the following cardiovascular risk factors: high blood pressure (systolic blood pressure 135 mmHg and over, and/or diastolic blood pressure 85 mmHg and over, or prescribed medication for hypertension), dyslipidemia (high-density lipoprotein cholesterol under 40 mg/dL and/or triglycerides 150 mg/dL and over , or prescribed medication for dyslipidemia), and hyperglycemia (fasting blood glucose 110mg/dL and over, and/or glycated hemoglobin A1c 5.5% and over, or prescribed medication for diabetes).
Key exclusion criteria	none
Target sample size	60

Research contact person
Name of lead principal investigator	Rumi Tsukinoki
Organization	Japanese Red Cross College of Nursing
Division name	community health nursing
Address	4-1-3, Hiroo, Shibuya, Tokyo, 150-0012
TEL	03-3409-0589
Email	rumitsukinoki@gmail.com

Public contact
Name of contact person	Rumi Tsukinoki
Organization	Japanese Red Cross College of Nursing
Division name	community health nursing
Address	4-1-3, Hiroo, Shibuya, Tokyo, 150-0012
TEL	03-3409-0589
Homepage URL
Email	rumitsukinoki@gmail.com

Sponsor
Institute	Japanese Red Cross College of Nursing
Institute
Department

Funding Source
Organization	the Ministry of Health, Labour and Welfare of Japan Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 12 Month 01 Day
Anticipated trial start date	2007 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 22 Day
Last modified on	2017 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034338