A non-inferiority trial comparing synchronous and asynchronous remotely-delivered lifestyle interventions

比较同步和异步远程生活方式干预措施的非劣效性试验

• 批准号: 10719358
• 负责人: SHERRY L. PAGOTO
• 金额: $ 40.64万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10719358
• 关键词: Address; Body Weight decreased; Computer software; Facebook; Human; Intervention; Lead; Maintenance; Modeling; Outcome; Participant; Patients; Persons; Phase; Policies; Privatization; Randomized; Randomized, Controlled Trials; Research; Schedule; Teleconferences; Telephone; Testing; Text; Time; Videoconferencing; Visit; Weight; Work; arm; behavioral health; comparison intervention; cost; effective intervention; efficacious intervention; experience; interest; lifestyle intervention; meetings; mobile application; patient engagement; peer; randomized trial; remote delivery; remote group; remote health care; remote intervention; scale up; secondary outcome; synchronous delivery; systematic review; telehealth; trial comparing; videoconference

Lifestyle interventions have had established efficacy for decades but they are costly and have poor scalability. Remotely delivered lifestyle interventions have increased the potential for scale and systematic reviews have found that they are effective, especially those that include human coaching. Some remote lifestyle interventions are synchronous, such that they are delivered via videoconferencing or phone. Other remote lifestyle interventions are asynchronous, such that they are delivered via online platforms that allow for clinicians and patients to engage via text exchanges or via online groups where patients engage with a clinician and each other by posting messages and contributing to discussion threads. The advantage of asynchronous approaches is 24/7 accessibility which makes them conducive to “just in time” support, allowing patients to engage anytime they want to, as opposed to in scheduled blocks of time each week. Asynchronous, remote interventions may also be more scalable than synchronous remote interventions. We conducted a trial of two asynchronous, remote lifestyle interventions—one with a group of 94 participants and one with a group of 40 participants. Findings revealed similar weight loss and acceptability between conditions. We also found that the larger group was more sustainable, such that participants continued to engage in the group for longer when we turned the groups over to participants to lead themselves for a year after the intervention ended—a period we referred to as the peer-led maintenance phase. The next step in this research is to examine how an asynchronous, remote intervention compares to a synchronous, remote intervention, not only in short term weight loss, but also in sustainability, scalability, and weight loss maintenance. Now that we’ve established the feasibility of conducing large asynchronous, remote groups, in the proposed trial we will randomize participants to large groups (n=82) in both conditions, which will allow us to compare synchronous to asynchronous remote interventions that are scaled up to a level that we have established is acceptable for asynchronous remote interventions. The purpose of the proposed trial is to determine whether an asynchronous, remote lifestyle intervention is non-inferior to a synchronous, remote lifestyle intervention in weight loss at 6 and 12 months, but more scalable and sustainable, and thus producing greater weight loss maintenance at 18 and 24 months. Establishing evidence for asynchronous interventions is more important than ever given that telehealth reimbursement for behavioral health has recently expanded but is still limited to synchronous forms of remote care. Asynchronous interventions may be more convenient for some people and possibly more scalable but for this treatment model to reach its potential, evidence for efficacy is needed to inform reimbursement policy. We hypothesize that an asynchronous, remote lifestyle intervention will produce similar initial weight loss as a synchronous, remote version but will be less expensive, more sustainable, and generate greater collective efficacy, which will drive greater weight loss maintenance at 18 and 24 months.

几十年来，生活方式干预措施已经确立了疗效，但它们成本高昂，可扩展性差。 远程提供的生活方式干预增加了规模和系统评价的潜力， 发现它们是有效的，特别是那些包括人类教练的。一些偏远的生活方式 干预措施是同步的，通过视频会议或电话提供。其它远程 生活方式干预是异步的，因此它们通过在线平台提供， 临床医生和患者通过文本交流或通过在线小组参与， 临床医生和其他人通过发布消息和促进讨论线程。的优点 异步方法是24/7的可访问性，这使得它们有利于“及时”支持， 患者可以随时参与，而不是每周安排时间。异步， 远程干预也可以比同步远程干预更可缩放。我们进行了一项试验 两个异步的，远程的生活方式干预-一组94名参与者，一组 40名参与者。结果显示，两种条件之间的体重减轻和可接受性相似。我们还发现 更大的群体更具有可持续性，因此参与者继续参与该群体的时间更长 当我们把这些小组交给参与者，让他们在干预结束后领导自己一年时， 我们称之为同伴主导的维护阶段。这项研究的下一步是研究如何 异步远程干预与同步远程干预相比， 减肥，而且在可持续性，可扩展性和减肥维持。既然我们已经建立了 进行大型异步远程组的可行性，在拟议的试验中，我们将随机分配参与者 在这两种情况下的大组（n=82），这将使我们能够比较同步和异步远程 扩展到我们已经建立的水平的干预对于异步远程 干预措施。这项试验的目的是确定一种异步的、遥远的生活方式是否 在6个月和12个月时，干预在减肥方面不劣于同步、远程生活方式干预， 但更可扩展和可持续，因此在18和24个月时产生更大的减肥维持。 建立异步干预的证据比以往任何时候都更加重要，因为远程医疗 行为健康的补偿最近已经扩大，但仍然限于同步形式的远程 在乎异步干预对某些人来说可能更方便，而且可能更具可扩展性， 这种治疗模式要发挥其潜力，需要有疗效证据来告知报销政策。我们 假设一个异步的，远程的生活方式干预将产生类似的初始体重减轻， 同步，远程版本，但将更便宜，更可持续，并产生更大的集体 疗效，这将在18个月和24个月时推动更大的减肥维持。