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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037455
Receipt No. 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 2020/01/22

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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
Email 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
Email harada@harbor.kobe-u.ac.jp

Sponsor
Institute Graduate School of Human Development and Environment, Kobe University
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042697

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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