UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004598 |
|---|---|
| Receipt number | R000005406 |
| Scientific Title | A Randomized Controlled Trial to evaluate the effects of the health guidance with video call as compared to the face to face health guidance. |
| Date of disclosure of the study information | 2010/11/22 |
| Last modified on | 2013/12/25 10:27:34 |
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Basic information
Public title
A Randomized Controlled Trial to evaluate the effects of the health guidance with video call as compared to the face to face health guidance.
Acronym
A Randomized Controlled Trial to evaluate the effects of the health guidance with video call.
Scientific Title
A Randomized Controlled Trial to evaluate the effects of the health guidance with video call as compared to the face to face health guidance.
Scientific Title:Acronym
A Randomized Controlled Trial to evaluate the effects of the health guidance with video call.
Region
| Japan |
Condition
Condition
The Volunteers who need motivational support in the "Specific Health Examination" (the person with obesity-related high risk factors)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of Health Guidance with video call as compared to the face to face health guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body Weight Loss after three month of the health examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
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
The face to face Health Guidance (20 minutes, 3 times in 90 days)
Interventions/Control_2
The health Guidance with video call (20 minutes, 3 times in 90 days)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The 40-74 year olds who need motivational supports in the "Specific Health Examination" (the person with obesity-related high risk factors).
2.The 30-39 year olds with obesity-related high risk factors, who are equivalent to those who need motivational supports in the "Specific Health Examination".
3.The person who don't need motivational supports but have obesity.
Key exclusion criteria
The person who need medical treatment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Fuji |
Organization
National Institute of Public health
Division name
Department of Human Resource Development
Zip code
Address
2-3-6 Minami, Wako-shi, Saitama, Japan 351-0197
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Public health
Division name
Department of Human Resource Development
Zip code
Address
2-3-6 Minami, Wako-shi, Saitama, Japan 351-0197
TEL
048-458-6130
Homepage URL
Sponsor or person
Institute
National Institute of Public health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 22 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 11 | Month | 22 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005406
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
