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

{"title":"Rationale and Trial Design of Feedbacks Using Behavioural Economic Theories on STEP Counts (FOOTSTEPS) Trial in Patients With Cardiovascular Disease","authors":"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","doi":"10.1016/j.cjco.2024.12.009","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div><div>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.</div><div>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.</div></div><div><h3>Trial Registration Number</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID NCT06446076</div></div>","PeriodicalId":36924,"journal":{"name":"CJC Open","volume":"7 4","pages":"Pages 535-544"},"PeriodicalIF":2.5000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"CJC Open","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589790X24006541","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

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.

Trial Registration Number

ClinicalTrials.gov ID NCT06446076

查看原文本刊更多论文

用行为经济学理论反馈心血管疾病患者步数（脚步）试验的基本原理和试验设计

体育活动对降低心血管疾病风险至关重要。无监督运动疗法的干预措施尚未广泛实施，很少有心血管疾病患者达到推荐的活动水平（例如，每天8000步）。以行为经济学为基础的项目增加了普通人群的身体活动；然而，它们在心血管疾病患者中的有效性（包括增益与损失框架的影响）仍不清楚。本研究调查了游戏化与社会激励和支持在使用智能手机应用程序促进心血管疾病患者体育活动方面的有效性。这项5组随机对照试验将从日本东京的一家急性三级急救医院招募成年心血管疾病患者。参与者将被随机分配到5组中的1组：对照组、游戏化（失去框架）、游戏化（获得框架）、游戏化（失去框架）+社会支持，或游戏化（获得框架）+社会支持。这款智能手机应用融合了游戏化元素：分数、排名和框架效果。社会支持机构的参与者将提名一名家庭成员或朋友接受每周的进度报告并给予鼓励。干预期6周，随访6周。主要结果是从基线到干预期平均每日步数的变化。目标样本量为325名参与者（每组65人），混合效应回归模型将用于评估身体活动的变化。该试验将评估游戏化与社会激励和支持的有效性，以增加心血管疾病患者的身体活动。这些发现可能为游戏化系统在改善这一人群预后方面的有效性提供有价值的证据。试验注册号clinicaltrials .gov ID NCT06446076

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊