UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030083
Receipt No. R000034338
Scientific Title effects of a worksite-based simple weight reduction program:cross over trial and 1 year follow up study
Date of disclosure of the study information 2017/11/22
Last modified on 2017/11/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title effects of a worksite-based simple weight reduction program:cross over trial and 1 year follow up study
Acronym effects of a worksite-based weight reduction program
Scientific Title effects of a worksite-based simple weight reduction program:cross over trial and 1 year follow up study
Scientific Title:Acronym 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
1st name
Middle name
Last name Rumi Tsukinoki
Organization Japanese Red Cross College of Nursing
Division name community health nursing
Zip code
Address 4-1-3, Hiroo, Shibuya, Tokyo, 150-0012
TEL 03-3409-0589
Email rumitsukinoki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Rumi Tsukinoki
Organization Japanese Red Cross College of Nursing
Division name community health nursing
Zip code
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)

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
2017 Year 11 Month 22 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
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
2005 Year 12 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.