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| Name | Class |
|---|---|
| Trigen | INDUSTRY |
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This is a prospective, randomized controlled trial. The aim of the study is to verify the effectiveness of interventions using gamification with social incentives and social support to increase physical activity in patients with CVD through randomized controlled trials.
The three aims of this randomized controlled trials;
Secondary Objective:
This trial will be a five-group, randomized controlled trial (RCT) with an intervention period of 6 weeks and a follow-up period of additional 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in this group will not receive goal-setting or gamification interventions during the 6-week intervention period and the additional 6-week follow-up period. As an "active control" during the 12-week trial period, participants will be able to check their daily step counts using an application with the same specifications. | |
| Gamification (Loss framing) | Experimental | This group will receive a gamification intervention with loss framing. |
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| Gamification (Gain framing) | Experimental | This group will receive a gamification intervention with gain framing. |
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| Gamification (Loss framing) + Social support | Experimental | This group will receive a gamification intervention with loss framing and a social support intervention. |
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| Gamification (Gain framing) + Social support | Experimental | This group will receive a gamification intervention with gain framing and a social support intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamification (Gain/Loss framing) | Behavioral | Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean daily step counts | The primary outcome is change in mean daily step counts from baseline to the 6-week intervention period. | From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days achieving their step goals | Secondary outcomes include the percentage of days achieving their step goals during the intervention and follow-up periods and the change in daily step counts from baseline to follow-up period. | From enrollment to the end of follow-up period at 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Physical Activity Questionnaire (IPAQ) | Change in the participant's subjective assessment of physical activity level measured using the International Physical Activity Questionnaire (IPAQ) Short Form. This is a survey that investigates how individuals engage in physical activity (how they move their bodies) in their daily lives. It is a questionnaire that assesses the duration and frequency of exercise based on intensity levels. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atsushi Mizuno, MD, PhD | Department of Cardiovascular Medicine, St. Luke's International Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's International Hospital | Tokyo | Tokyo | 1048560 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40433138 | Derived | Suzuki T, Aoki J, Abe K, Asano T, Yoneoka D, Sato S, Rewley J, Miyata K, Ono M, Saito A, Kanie T, Okui K, Takahashi A, Isa K, Takasago S, Shiina Y, Nishihata Y, Niinuma H, Masuda K, Kijima Y, Nishida H, Komiyama N, Sugibuchi K, Suzuki Y, Igarashi A, Suzumura S, Tsurugi N, Okamura D, Mizuno A; FOOTSTEPS Investigators. Rationale and Trial Design of Feedbacks Using Behavioural Economic Theories on STEP Counts (FOOTSTEPS) Trial in Patients With Cardiovascular Disease. CJC Open. 2024 Dec 27;7(4):535-544. doi: 10.1016/j.cjco.2024.12.009. eCollection 2025 Apr. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Social support | Behavioral | Participants in this group are asked to designate a family member or friend to provide social support. This supporter is encouraged to check the participant's progress and provide support during the interventional period. The supporter will also receive weekly emails throughout the period, informing them about the participant's daily step counts, achievement status, points, levels, and other relevant information. |
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| From enrollment to the end of follow-up period at 14 weeks |
| Change in Body weight (BMI) | Change in body weight (BMI) (kg/m^2) | From enrollment to the end of follow-up period at 14 weeks |
| Change in LDL/HDL cholesterol | Change in LDL/HDL cholesterol (mg/dL) | From enrollment to the end of follow-up period at 14 weeks |