Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

项目总结/摘要 数十年的研究表明，行为肥胖治疗可以产生临床意义 减轻体重，改善健康和疾病风险/严重程度。然而，这些治疗方法并没有 由于费用高和缺乏合格的提供者，因此传播范围很广。因此，我们的目标是全面发展一个 将产生临床上显著的体重减轻的自动化在线肥胖治疗（即，≥初始值的5% 体重）时，在各种设置在线交付。我们的3个月计划，Rx减肥（RxWL）， 在转诊的患者中，产生了具有临床意义的平均±SD体重减轻，为初始体重的5.8± 4.4%， 医生（N=154），工作场所（N=75）为5.8 ± 5.2%，社区环境（N=230）为4.2± 5.3%。这些 在6个月随访时，体重减轻基本保持不变。鉴于这些积极的结果，医疗保健 利益攸关方表示希望继续传播RxWL。为了最大限度地保障公众健康 传播RxWL和类似计划的影响，并推进在线行为干预的科学 总的来说，必须评估创新的行为干预成分， 优化减肥效果。尽管有希望平均体重减轻，但只有大约一半的参与者接受了治疗。 在线实现重量损失> 5%。此外，减肥对健康的益处取决于剂量; 因此，优化RxWL以产生更大的平均体重减轻将增强其健康益处。优化 RxWL还将为优化其他在线治疗提供模板。因为数字健康技术 发展迅速，我们将使用多阶段优化策略（MOST）框架， 有效地确定5个创新干预成分中的哪一个（如果有的话），单独或组合， 在12- 18岁时，RxWL计划实现≥5%体重减轻和平均体重减轻的患者比例 个月将测试的5个干预组成部分是：（a）基于网络的虚拟现实干预培训 在基本的行为减肥技能;量身定制的互动干预目标（B）结构化的身体活动 以及（c）饮食失调;（d）社会互动的平台，包括友好竞争的机会， 以及（e）互动视频反馈，内容针对每个参与者的独特需求，重点是 饮食技巧在N=32的初始测试后，通过反馈完善并最终确定干预组件 从咨询委员会，N=384名BMI ≥ 25的个体将随机接受RxWL和0-5个 实验干预成分在一个完整的析因实验。这个设计可以让我们确定 哪些干预成分最大限度地减轻体重，以及是否存在有利的组合， 件.此外，通过评估每个组件对近端结局的影响（即，调解员） 我们将不仅了解哪些成分有效（或无效），而且了解它们为什么或如何发挥作用。 该项目推进了行为肥胖治疗的科学，并将直接影响患者的护理 接收RxWL。

PROJECT SUMMARY/ABSTRACT Decades of research have demonstrated that behavioral obesity treatments can produce clinically significant weight losses that improve health and disease risk/severity. However, these treatments have not been disseminated widely due to high costs and lack of qualified providers. We therefore aimed to develop a fully automated online obesity treatment that would produce clinically significant weight losses (i.e., ≥ 5 % of initial body weight) when delivered online in a variety of settings. Our 3-month program, Rx Weight Loss (RxWL), produced clinically significant mean±SD weight losses of 5.8±4.4 % of initial body in patients referred by physician (N=154), 5.8 ±5.2 % in worksites (N=75), and 4.2±5.3 % in community settings (N=230). These weight losses were largely maintained at 6-month follow-up. Given these positive results, healthcare stakeholders have expressed a desire to pursue dissemination of RxWL. In order to maximize the public health impact of disseminating RxWL and similar programs, and advance the science of online behavioral intervention in general, it is imperative to evaluate innovative behavioral intervention components with the potential to optimize weight loss outcomes. Despite promising mean weight losses, only about half of participants treated online achieve weight losses of > 5%. Furthermore, the health benefits of weight loss are dose dependent; optimizing RxWL to produce larger mean weight losses would therefore enhance its health benefits. Optimizing RxWL would also provide a template for optimizing other online treatments. Because digital health technology evolves rapidly, we will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, of the RxWL program at 12- months. The 5 intervention components to be tested are: (a) Web-based virtual reality intervention for training in basic behavioral weight loss skills; tailored interactive intervention targeting (b) structured physical activity and (c) dysregulated eating; (d) a platform for social interaction including opportunities for friendly competition, and (e) interactive video feedback with content tailored to the unique needs of each participant and a focus on dietary skills. After initial testing with N=32 to refine and finalize the intervention components with feedback from advisory boards, N=384 individuals with BMI ≥ 25 will be randomized to receive RxWL and 0-5 of the experimental intervention components in a full factorial experiment. This design will allow us to determine which intervention components maximize weight loss and whether there are favorable combinations of components. In addition, by evaluating the effects of each component on proximal outcomes (i.e., mediators) we will learn not only which components are (or are not) effective but also why or how they exert their effects. This project advances the science of behavioral obesity treatment, and will directly impact the care of patients receiving RxWL.