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
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
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
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
