UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033276 |
|---|---|
| Receipt number | R000037936 |
| Scientific Title | Effect of financial incentive to increase walking step: a randomised controlled trial. |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2021/01/08 10:35:11 |
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Basic information
Public title
Effect of financial incentive to increase walking step: a randomised controlled trial.
Acronym
Effect of financial incentive to increase walking step.
Scientific Title
Effect of financial incentive to increase walking step: a randomised controlled trial.
Scientific Title:Acronym
Effect of financial incentive to increase walking step.
Region
| Japan |
Condition
Condition
Healthy people who have no physical activity habits
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to test whether financial incentives would increase walking steps among adult individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of increase in average walking steps compared with baseline walking levels for three weeks.
Key secondary outcomes
･ Proportion of participants who increase over 1,000 steps from the baseline walking levels (average walking steps) for three weeks.
･ Incident fall
･ Incident pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group.
Intervention is financial incentive. During next 3 weeks (intervention period) of the baseline, the participants of the intervention group are given financial incentive to their IC Card if they achieve walking step goals as following:
1) Average walking steps for intervention period is >=6,000 steps/day: 500 Japanese yen worth of points.
2) Increase in average walking steps for intervention period is >=1,000 steps/day from their baseline walking levels: 500 Japanese yen worth of points.
Interventions/Control_2
Control group (Waitlist control).
The control group will be given the chance of financial incentive (mentioned above) in last three weeks, and thereby given opportunity of the incentive for all participants if they achieve walking step goals.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women (20 years or more) living in Nakayama area, Aoba-ku, Sendai city.
2) Persons who have an IC Card for Community Development of Nakayama area (Nakayama Machi-dukuri IC Card).
3) Persons who can walk themselves without using cane, walker for elderly, or wheelchair.
Key exclusion criteria
1) Persons whose physical activity is restricted by physician.
2) Persons who developed heart attack or sroke within past six months.
3) Persons whose blood pressure over 180mmHg systolic or 110mmHg diastolic.
4) Persons who habitually perform exercise (4 Mets or more) more than 2 times per week.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Tsuji |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Epidemiology
Zip code
980-8575
Address
980-8575 2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8121
nakayama-p@pbhealth.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasutake |
| Middle name | |
| Last name | Tomata |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Epidemiology
Zip code
980-8575
Address
980-8575 2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8121
Homepage URL
nakayama-p@pbhealth.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TERUMO Foundation for Life Sciences and Arts
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Tohoku University Graduate School of Medicine
Address
980-8575, 2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学大学院医学系研究科（宮城県）
Tohoku University Graduate School of Medicine (Miyagi, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/6/e026086
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/10/11/e037303
Number of participants that the trial has enrolled
72
Results
During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311).
Results date posted
| 2021 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 04 | Day |
Baseline Characteristics
In August 2018, leaflets were distributed to each house in the Nakayama area of Aoba-ku in Sendai city, Japan. Applicants who met the inclusion criteria could apply through an online application, fax, or telephone.
Participant flow
In a briefing session held in September 2018, the researchers rechecked the inclusion and exclusion criteria for each applicant. All the selected participants provided informed consent to participate in the study. At the briefing session, each participant was provided with a pedometer containing a three-axis acceleration sensor. The number of daily walking steps at baseline was measured in the first 3 weeks of the study period (weeks 1-3) for all the participants. After completing the 3-week baseline period, participants were randomised to one of the two groups based on the permuted block method by computer-generated randomisation. The allocation sequence was managed by two experienced random assignment researchers.
Adverse events
Incident falls were reported in two participants (5.7%) in the intervention group and in one participant (2.9%) in the control group, and the incident rate was not significantly different (p=0.555). Incident pain was reported in four participants (14.3%) in the intervention group and in one participant (4.2%) in the control group, and the incident rate was not significantly different (p=0.217).
Outcome measures
The primary outcome was the mean increase in the number of daily steps during the intervention period compared with that at baseline.
The secondary outcomes were (1) an increase in the number of daily steps by over 1000 at weeks 4-6 or weeks 7-9 from baseline, (2) incident falls at weeks 4-6 or weeks 7-9 and (3) incident pain at weeks 4-6 or weeks 7-9.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://bmjopen.bmj.com/content/10/11/e037303
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037936
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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