UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030083
Receipt number 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 13:00:55

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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 or person

Institute

Japanese Red Cross College of Nursing

Institute

Department

Personal name



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

Value
https://center6.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