UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007357 |
|---|---|
| Receipt number | R000008667 |
| Scientific Title | A community-based intervention using TAKE10! program to improve dietary habit and to promote physical activity among the elderly: A cluster randomizes trail |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2012/02/22 16:20:14 |
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Basic information
Public title
A community-based intervention using TAKE10! program to improve dietary habit and to promote physical activity among the elderly: A cluster randomizes trail
Acronym
A community-based intervention using TAKE10! program to improve dietary habit and to promote physical activity among the elderly: A cluster randomizes trail
Scientific Title
A community-based intervention using TAKE10! program to improve dietary habit and to promote physical activity among the elderly: A cluster randomizes trail
Scientific Title:Acronym
A community-based intervention using TAKE10! program to improve dietary habit and to promote physical activity among the elderly: A cluster randomizes trail
Region
| Japan |
Condition
Condition
Poor Nutritional condition
Sarcopenia
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of this program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in self-related health, dietary variety score (DVS), frequencies of foods intake and frequencies of regular physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group
A general lecture on the importance of dietary variety and five times sessions once every two weeks for 3 months, aiming to help the participants put good dietary habits and proper physical activity into practice on a daily basis using TAKE10! program
Interventions/Control_2
Control group
No treatment (3 months)
After 3 months, the same intervention with the intervention group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 or above
Agreement with the main objectives
Ability to come to the site by themselves
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Shuichi Kimura |
Organization
International Life Sciences Institute Japan (ILSI Japan)
Division name
President
Zip code
Address
Kojimachi RK Bldg., 2-6-7 Kojimachi, Chiyoda-ku , Tokyo 102-0083, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Kimura |
Organization
International Life Sciences Institute Japan (ILSI Japan)
Division name
Center for Health Promotion
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
International Life Sciences Institute Japan (ILSI Japan)
Institute
Department
Personal name
Funding Source
Organization
ILSI Japan CHP PAN project
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Daily Association
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
| 2012 | Year | 02 | 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
| 2005 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 22 | Day |
Last modified on
| 2012 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008667
