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

基本信息

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
项目类别：
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

项目摘要

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.

生活方式干预措施几十年来已取得成效，但成本高昂且可扩展性较差。远程提供的生活方式干预措施增加了规模化的潜力，系统审查也增加了发现它们是有效的，尤其是那些包含人工指导的远程生活方式。干预是同步的，因此可以通过视频会议或其他远程方式进行。生活方式干预是异步的，因此它们是通过在线平台提供的，允许战士和患者通过文本交换或通过在线群组进行互动，患者可以在其中与患者互动临床医生和彼此通过发布消息并参与讨论主题来相互交流。异步方法是 24/7 可访问性，这使得它们有利于“及时”支持，允许患者可以随时参与，而不是每周安排一段时间。远程干预也可能比同步远程干预更具可扩展性。我们进行了一项试验。两项异步、远程生活方式干预——一项由 94 名参与者组成，另一项由 1 名参与者组成我们还发现，40 名参与者的体重减轻和可接受程度相似。更大的群体更具可持续性，因此能够更长时间地继续参与该群体当我们将小组交给参与者，让他们在干预结束后的一年内领导自己时—— 我们将其称为同行主导的维护阶段。本研究的下一步是研究如何进行维护。异步远程干预与同步远程干预相比，不仅在短期内减肥，而且还包括可持续性、可扩展性和减肥维持。进行大型异步远程小组的可行性，在拟议的试验中，我们将随机分配参与者在这两种情况下都属于大组（n=82），这将使我们能够比较同步与异步远程扩大到我们已经建立的异步远程可接受的水平的干预措施拟议试验的目的是确定是否存在异步、远程生活方式。干预在 6 个月和 12 个月时的减肥效果并不逊色于同步远程生活方式干预，但更具可扩展性和可持续性，从而在 18 个月和 24 个月时产生更大的减肥维持效果。鉴于远程医疗的发展，建立异步干预的证据比以往任何时候都更加重要行为健康的报销最近有所扩大，但仍仅限于同步形式的远程治疗异步干预对于某些人来说可能更方便，并且可能更具可扩展性，但对于某些人来说可能更方便。为了发挥这种治疗模式的潜力，我们需要疗效证据来告知报销政策。认为异步、远程生活方式干预将产生与同步、远程版本，但成本更低，更具可持续性，并产生更大的集体功效，这将在 18 个月和 24 个月时推动更大的减肥维持。