UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052303 |
|---|---|
| Receipt number | R000059711 |
| Scientific Title | A randomized controlled crossover trial to assess whether lottery incentive or fixed Incentive is more effective in changing behavior among participants using a pedometer application with financial incentives |
| Date of disclosure of the study information | 2023/09/26 |
| Last modified on | 2024/10/22 20:45:39 |
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Basic information
Public title
A randomized controlled crossover trial to assess whether lottery incentive or fixed Incentive is more effective in changing behavior among participants using a pedometer application with financial incentives
Acronym
A randomized controlled crossover trial to assess whether lottery incentive or fixed Incentive is more effective in changing behavior among participants using a pedometer application with financial incentives
Scientific Title
A randomized controlled crossover trial to assess whether lottery incentive or fixed Incentive is more effective in changing behavior among participants using a pedometer application with financial incentives
Scientific Title:Acronym
A randomized controlled crossover trial to assess whether lottery incentive or fixed Incentive is more effective in changing behavior among participants using a pedometer application with financial incentives
Region
| Japan |
Condition
Condition
Healthy volunteers with no exercise habits
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether lottery Incentive or fixed incentive is more effective in changing behavior among participants using a pedometer application with financial incentives.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between the first(fixed incentives)app and second(lottery incentives) app in the number of successful attempts of challenge in a week
Key secondary outcomes
.Difference between the first(fixed incentives)app and second(lottery incentives) app in the number of successful attempts of challenge in a week
･Difference between the first and second app in daily steps
･Difference between the first and second app in daily walking distance
･Difference between the preferred app (App1 or 2) and non-preferred app in the number of successful attempts of challenge in a week
･Difference between the preferred app (App1 or 2) and non-preferred app in daily steps
･Difference between the preferred app (App1 or 2) and non-preferred apps in daily walking distance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of a smartphone app that measures moderate physical activity and provides fixed financial incentives based on exercise time
Interventions/Control_2
Use of a smartphone app that measures moderate physical activity and provides lottery based financial incentives based on exercise time
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･aged 18 to 60 at the time of inclusion
･able to walk independently without the use of a walking aid
･able to communicate, read and write in Japanese
･owns an iPhone and can agree to carry it at all times during the study period
･do not own a smartwatch, or if they do, are willing to consent to unpair their smartwatch from their iPhone during the study
･can provide written consent to participate in the study of his/her own free will
Key exclusion criteria
･already exercising at least 3 days a week
･prohibited from exercising by a physician for any reason
･systolic blood pressure 160 mmHg or higher or diastolic blood pressure 110 mmHg or higher at the time of inclusion
･judged by the investigator to be ineligible for participation in the study.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
khayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
Homepage URL
khayashi@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Kosuke Hayashi
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Hospital, Clinical Trial Ethics Committee
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
Tel
0975866163
gcrcjimu@oita-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
| 2023 | Year | 09 | 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
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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059711
