Rationale and Trial Design of Feedbacks Using Behavioural Economic Theories on STEP Counts (FOOTSTEPS) Trial in Patients With Cardiovascular Disease

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CJC Open Pub Date : 2025-04-01 DOI:10.1016/j.cjco.2024.12.009

Takahiro Suzuki MD, MPH , Jiro Aoki MD, PhD , Kohei Abe MD , Taku Asano MD, PhD , Daisuke Yoneoka PhD , Shuntaro Sato PhD , Jeffrey Rewley PhD , Kotaro Miyata MD , Masafumi Ono MD, PhD , Akira Saito MD, MPH , Takayoshi Kanie MD , Kenta Okui MD , Akinari Takahashi MD , Koichiro Isa MD , Satoshi Takasago MD , Yumi Shiina MD, PhD , Yosuke Nishihata MD, PhD , Hiroyuki Niinuma MD, PhD , Keita Masuda MD, PhD , Yasufumi Kijima MD, PhD , Atsushi Mizuno MD, PhD

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引用次数: 0

Abstract

Physical activity is crucial for reducing cardiovascular disease (CVD) risk. Interventions for nonsupervised exercise therapy have not been broadly implemented, and few patients with CVD achieve the recommended activity levels (eg, 8000 daily steps). Behavioural economics-based programs increased physical activity in the general population; however, their effectiveness—including the impact of gain vs loss framing—in patients with CVD remains unclear. This study investigates the effectiveness of gamification with social incentives and support in promoting physical activity among patients with CVD using smartphone applications.

This 5-arm, randomized controlled trial will recruit adult patients with CVD from a single acute tertiary emergency hospital in Tokyo, Japan. Participants will be randomly assigned to 1 of 5 groups: control, gamification (loss framing), gamification (gain framing), gamification (loss framing) + social support, or gamification (gain framing) + social support. The smartphone application incorporates gamification elements: points, rankings, and framing effects. Participants in social support arms will nominate a family member or friend to receive weekly progress reports and provide encouragement. The intervention period is 6 weeks, followed by a 6-week follow-up. The primary outcome is the change in mean daily step count from baseline to the intervention period. The target sample size is 325 participants (65 per arm), and mixed-effects regression models will be used to assess changes in physical activity.

This trial will evaluate the effectiveness of gamification with social incentives and support to increase physical activity in patients with CVD. These findings may provide valuable evidence regarding the effectiveness of gamification systems in improving outcomes for this population.