UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002967
Receipt number R000003600
Scientific Title Effect of body weight measuring and advice by family doctors on body weight reduction for obese patients: a randomized controlled trial in a Japanese family practice.
Date of disclosure of the study information 2010/01/04
Last modified on 2011/12/13 21:05:49

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Basic information

Public title

Effect of body weight measuring and advice by family doctors on body weight reduction for obese patients: a randomized controlled trial in a Japanese family practice.

Acronym

Hobara Outpatient Body weight Assessment and weight Reduction Advice trial. (HOBARA trial )

Scientific Title

Effect of body weight measuring and advice by family doctors on body weight reduction for obese patients: a randomized controlled trial in a Japanese family practice.

Scientific Title:Acronym

Hobara Outpatient Body weight Assessment and weight Reduction Advice trial. (HOBARA trial )

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find any effect of body weight measuring and advising by family doctors on body weight reduction for regularly visiting obese patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Body weight change

Key secondary outcomes

Abdominal Circumference
Blood Pressure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Body weight measuring by family doctors

Interventions/Control_2

Advice on body weight reduction by family doctors

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who have diagnosed at least one of the followings: hypertension, dyslipidemia, or type 2 diabetes mellitus.
Patients who visit the family medicine clinic every 28 to 90 days.
Patients whose BMI is greater than 25.

Key exclusion criteria

Past history of psychiatric diseases.
Past history of malignant diseases.
Ongoing hormone therapy.
Inability to walk.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuki Kassai

Organization

Fukushima Medical University

Division name

Department of Community and Family Medicine

Zip code


Address

1 Hikarigaoka, Fukushima City Fukushima Prefecture, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Kanke

Organization

Fukushima Medical University

Division name

Department of Community and Family Medicine

Zip code


Address

1 Hikarigaoka, Fukushima City Fukushima Prefecture, Japan

TEL

024-547-1516

Homepage URL


Email

kanke@fmu.ac.jp


Sponsor or person

Institute

Department of Community and Family Medicine, Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

保原中央クリニック(福島県)


Other administrative information

Date of disclosure of the study information

2010 Year 01 Month 04 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

2009 Year 12 Month 30 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry

2011 Year 10 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 01 Month 03 Day

Last modified on

2011 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name