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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033276
Receipt No. 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

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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
Email 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
Email nakayama-p@pbhealth.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037936

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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