UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037455 |
|---|---|
| Receipt number | R000042697 |
| Scientific Title | Effects of health behavior change intervention among older adults |
| Date of disclosure of the study information | 2019/07/26 |
| Last modified on | 2022/07/25 10:09:50 |
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Basic information
Public title
Effects of health behavior change intervention among older adults
Acronym
Effects of health behavior change intervention among older adults
Scientific Title
Effects of health behavior change intervention among older adults
Scientific Title:Acronym
Effects of health behavior change intervention among older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine effects of behavioral skill development and social interaction on health behavior change among older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Behaviors (eating behavior, physical activity, sedentary behavior)
Key secondary outcomes
Beliefs and attitudes toward health behaviors
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Once-weekly behavioral intervention for 10 weeks
Interventions/Control_2
Control group: waiting list
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Able to walking for 40 to 50 minutes with hilly area
Allowed to do exercises by physicians if having major diseases
Key exclusion criteria
Not able to walking for 40 to 50 minutes with hilly area
Not allowed to do exercises by physicians if having major diseases
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
harada@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
Homepage URL
harada@harbor.kobe-u.ac.jp
Sponsor or person
Institute
Graduate School of Human Development and Environment, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Human Development and Environment, Kobe University
Address
3-11 Tsurukabuto, Nada, Kobe
Tel
078-803-7905
hudev-soumu@office.kobe-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
| 2019 | Year | 07 | Month | 26 | 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
138
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
| 2019 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042697
| 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 |
