UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035222 |
|---|---|
| Receipt number | R000040115 |
| Scientific Title | Evaluation study on the degree of influence of incentive on health behavior |
| Date of disclosure of the study information | 2019/01/09 |
| Last modified on | 2018/12/11 14:52:16 |
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Basic information
Public title
Evaluation study on the degree of influence of incentive on health behavior
Acronym
Evaluation study on the degree of influence of incentive on health behavior
Scientific Title
Evaluation study on the degree of influence of incentive on health behavior
Scientific Title:Acronym
Evaluation study on the degree of influence of incentive on health behavior
Region
| Japan |
Condition
Condition
Condition between illness and health
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, we provide an application with an incentive function and give incentive points according to a change in consciousness behavior to health. We conduct evaluation research to confirm the usefulness of this incentive model. We also read changes in health consciousness and motivation through questionnaires and evaluate how incentives affect health consciousness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicators of health behavior to which incentive points are given: Evaluate the direct influence of incentives due to the difference in change in 'walking exercise and health awareness check'.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Measurement of step count
Interventions/Control_2
Awareness check answer
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Randomization is done so that gender, age and baseline are equal. Gender is male / female, age is high / low stratification, baseline evaluates exercise capacity (walking) measured at the start of the study and athletic ability (walking) measured in the past and performs block randomization.
Key exclusion criteria
1) Persons who have a disorder that is an obstacle to this study
2) other persons who are judged inappropriate by the responsible person or the shared person in the research
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Nakano |
Organization
FUJITSU LIMITED
Division name
DIGITAL TRANSFORMATION BUSINESS UNIT
Zip code
Address
PO Box63, Nisseiaroma Square, 5-37-1, Kamata, Ota-ku, Tokyo, 144-0052, Japan
TEL
03-6424-9598
nakano.naoki@jp.fujitsu.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Nakano |
Organization
FUJITSU LIMITED
Division name
DIGITAL TRANSFORMATION BUSINESS UNIT
Zip code
Address
PO Box63, Nisseiaroma Square, 5-37-1, Kamata, Ota-ku, Tokyo, 144-0052, Japan
TEL
03-6424-9598
Homepage URL
nakano.naoki@jp.fujitsu.com
Sponsor or person
Institute
FUJITSU LIMITED
Institute
Department
Personal name
Funding Source
Organization
FUJITSU LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokai University
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
| 2019 | Year | 01 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 11 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040115
| 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 |
