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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002967
Receipt No. 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

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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
Institute Department of Community and Family Medicine, Fukushima Medical University
Institute
Department

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
URL(English) https://upload.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


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