数字治疗干预在体育活动中增强情感反应的随机试验：情感研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-12 DOI:10.1016/j.cct.2025.107945

Genevieve F. Dunton , Lori Hatzinger , Rachel Crosley-Lyons , Micaela Hewus , Wei-Lin Wang , Delfien Van Dyck , Jimi Huh

{"title":"数字治疗干预在体育活动中增强情感反应的随机试验：情感研究方案。","authors":"Genevieve F. Dunton , Lori Hatzinger , Rachel Crosley-Lyons , Micaela Hewus , Wei-Lin Wang , Delfien Van Dyck , Jimi Huh","doi":"10.1016/j.cct.2025.107945","DOIUrl":null,"url":null,"abstract":"<div><div>Physical activity interventions often fail to address features of physical activity that may lead to maintaining behavior, such as emotional experiences during behavior. Although some people experience pleasure during physical activity, it can be extremely unpleasant for others. Affective mechanisms (e.g., affective responses during behavior, anticipated affect about future behavior, affectively-charged motivations for future behavior) can influence the likelihood of engaging in future behavior. Using an experimental medicine approach, this Phase 1 trial of the eMOTION intervention aims to test whether affective mechanisms can be experimentally manipulated in real-world settings and whether affective mechanisms mediate the intervention effects on physical activity behavior. Pathways will be tested through a daily digital therapeutics intervention delivered using interactive mobile technology among physically inactive adults with overweight or obesity. An affect-based condition will provide daily goals related to enjoyment and feeling good during physical activity. In contrast, an intensity-based condition will provide daily goals for heart rate targets to achieve during physical activity. Two enhancements to the affect-based condition are: (1) tailored activity type and context recommendations to satisfy personally important psychological needs and (2) savoring practices to increase the saliency of positive emotions during physical activity. An 18-week study will optimize the treatment effects using a factorial (within x between) cross-over design (<em>N</em> = 280). Affective mechanisms and physical activity will be measured using real-time ecological momentary assessment (EMA) and accelerometry, respectively. Overall, this study fulfills an explicit need for the systematic translation of basic behavioral science processes into health behavioral change strategies through early-stage intervention development.</div><div>Trial Registration Number: <span><span>NCT06570642</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107945"},"PeriodicalIF":2.0000,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study\",\"authors\":\"Genevieve F. Dunton , Lori Hatzinger , Rachel Crosley-Lyons , Micaela Hewus , Wei-Lin Wang , Delfien Van Dyck , Jimi Huh\",\"doi\":\"10.1016/j.cct.2025.107945\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Physical activity interventions often fail to address features of physical activity that may lead to maintaining behavior, such as emotional experiences during behavior. Although some people experience pleasure during physical activity, it can be extremely unpleasant for others. Affective mechanisms (e.g., affective responses during behavior, anticipated affect about future behavior, affectively-charged motivations for future behavior) can influence the likelihood of engaging in future behavior. Using an experimental medicine approach, this Phase 1 trial of the eMOTION intervention aims to test whether affective mechanisms can be experimentally manipulated in real-world settings and whether affective mechanisms mediate the intervention effects on physical activity behavior. Pathways will be tested through a daily digital therapeutics intervention delivered using interactive mobile technology among physically inactive adults with overweight or obesity. An affect-based condition will provide daily goals related to enjoyment and feeling good during physical activity. In contrast, an intensity-based condition will provide daily goals for heart rate targets to achieve during physical activity. Two enhancements to the affect-based condition are: (1) tailored activity type and context recommendations to satisfy personally important psychological needs and (2) savoring practices to increase the saliency of positive emotions during physical activity. An 18-week study will optimize the treatment effects using a factorial (within x between) cross-over design (<em>N</em> = 280). Affective mechanisms and physical activity will be measured using real-time ecological momentary assessment (EMA) and accelerometry, respectively. Overall, this study fulfills an explicit need for the systematic translation of basic behavioral science processes into health behavioral change strategies through early-stage intervention development.</div><div>Trial Registration Number: <span><span>NCT06570642</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"154 \",\"pages\":\"Article 107945\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-05-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714425001399\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425001399","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

身体活动干预往往不能解决身体活动可能导致维持行为的特征，例如行为期间的情绪体验。虽然有些人在体育活动中体验到快乐，但对其他人来说，这可能是非常不愉快的。情感机制（如行为中的情感反应、对未来行为的预期影响、对未来行为的情感驱动动机）可以影响参与未来行为的可能性。采用实验医学方法，本一期试验旨在测试情感机制是否可以在现实环境中被实验操纵，以及情感机制是否介导了干预对身体活动行为的影响。途径将通过每日自我调节干预进行测试，该干预使用交互式移动技术，在超重或肥胖的缺乏运动的成年人中进行。基于情感的条件将提供与体育活动中的享受和感觉良好相关的日常目标。相反，以强度为基础的条件将提供在体育活动中达到的心率目标的每日目标。对情感条件的两个增强是：(1)量身定制的活动类型和情境建议，以满足个人重要的心理需求；(2)品味练习，以增加体育活动中积极情绪的显着性。一项为期18周的研究将使用因子交叉设计（N = 280）优化治疗效果。情感机制和身体活动将使用实时生态瞬间评估（EMA）和加速度计来测量。总体而言，本研究满足了通过早期干预发展将基本行为科学过程系统地转化为健康行为改变策略的明确需求。试验注册号：NCT06570642。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study

Physical activity interventions often fail to address features of physical activity that may lead to maintaining behavior, such as emotional experiences during behavior. Although some people experience pleasure during physical activity, it can be extremely unpleasant for others. Affective mechanisms (e.g., affective responses during behavior, anticipated affect about future behavior, affectively-charged motivations for future behavior) can influence the likelihood of engaging in future behavior. Using an experimental medicine approach, this Phase 1 trial of the eMOTION intervention aims to test whether affective mechanisms can be experimentally manipulated in real-world settings and whether affective mechanisms mediate the intervention effects on physical activity behavior. Pathways will be tested through a daily digital therapeutics intervention delivered using interactive mobile technology among physically inactive adults with overweight or obesity. An affect-based condition will provide daily goals related to enjoyment and feeling good during physical activity. In contrast, an intensity-based condition will provide daily goals for heart rate targets to achieve during physical activity. Two enhancements to the affect-based condition are: (1) tailored activity type and context recommendations to satisfy personally important psychological needs and (2) savoring practices to increase the saliency of positive emotions during physical activity. An 18-week study will optimize the treatment effects using a factorial (within x between) cross-over design (N = 280). Affective mechanisms and physical activity will be measured using real-time ecological momentary assessment (EMA) and accelerometry, respectively. Overall, this study fulfills an explicit need for the systematic translation of basic behavioral science processes into health behavioral change strategies through early-stage intervention development.

Trial Registration Number: NCT06570642

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.