UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006125 |
|---|---|
| Receipt number | R000007247 |
| Scientific Title | Efficacy of a tentative free food preparation task as a behavior therapy in specific counseling guidance of Japan. |
| Date of disclosure of the study information | 2011/08/15 |
| Last modified on | 2020/07/17 15:11:44 |
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Basic information
Public title
Efficacy of a tentative free food preparation task as a behavior therapy in specific counseling guidance of Japan.
Acronym
Efficacy of a tentative free food preparation task.
Scientific Title
Efficacy of a tentative free food preparation task as a behavior therapy in specific counseling guidance of Japan.
Scientific Title:Acronym
Efficacy of a tentative free food preparation task.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A task of preparing a meal from one hundred realistic food cards (a tentative free food preparation task) is an effective method of nutrition guidance.
In our hospital, we are running this tentative free food preparation task for specific counseling guidance of Japan.
On the other hand, there were little studies that assessed the efficacy of this tentative free food preparation task for specific counseling guidance.
In this study, we examine the outcome of the administration of the tentative free food preparation task for specific counseling guidance in our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We measure a specific counseling guidance continuance rate, weight, a body-mass index, blood pressure, lipid metabolism, glucose metabolism, the food preparation property and analyze the change of the value before and after guidance.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subject who underwent specific counseling guidance in Shonin hospital.
Key exclusion criteria
1) The subjects taking any medication.
2) The subjects who had malignant neoplasm disease.
3) The subject who was counted as an inappropriate case by researchers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Chiba |
Organization
Oita University, Faculty of Medicine
Division name
Medicine 1
Zip code
8795593
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
TEL
097-586-5793
schiba@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Chiba |
Organization
Oita University, Faculty of Medicine
Division name
Medicine 1
Zip code
8795593
Address
1-1, Idaigaoka, Hazama town, Yufu city
TEL
0975494411
Homepage URL
schiba@oita-uac.jp
Sponsor or person
Institute
Shonin Hospital, Shoninkai Medical Corporation.
Institute
Department
Personal name
Funding Source
Organization
Oita University, Faculty of Medicine
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
Oita University, Faculty of Medicine
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
Tel
0975865623
schiba@oita-u.ac.jp
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
| 2011 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2011 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007247
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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