UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015954 |
|---|---|
| Receipt number | R000018563 |
| Scientific Title | Intervention program by health promotion volunteer for improving food variety in old age |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2016/08/26 11:13:55 |
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Basic information
Public title
Intervention program by health promotion volunteer for improving food variety in old age
Acronym
Intervention program by health promotion volunteer for improving food variety in old age
Scientific Title
Intervention program by health promotion volunteer for improving food variety in old age
Scientific Title:Acronym
Intervention program by health promotion volunteer for improving food variety in old age
Region
| Japan |
Condition
Condition
Food variety
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of an intervention program by health promotion volunteer to improve food variety for older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food variety score
Key secondary outcomes
Dietary-related QOL
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Lecture of the importance of food variety by health promotion volunteer (four sessions)
Group work by participants and health promotion volunteer
Interventions/Control_2
No intervention
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
| 65 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Less than 3 points in food variety score
Key exclusion criteria
More than 4 points in food variety score
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Taguchi |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
Address
2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7922
ataguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Taguchi |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
Address
2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7922
Homepage URL
ataguchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Mitsubishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2014 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018563
