Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss

 描述(由申请人提供)：为了有力地影响推动肥胖治疗领域的行为体重管理干预试验的设计和成功，我们提出了两项重大进展。首先，我们为成功的减肥维持设定了一个在临床和行为上都有意义的新指标--减重=初始体重的7%，并随着时间的推移保持体重稳定的个人比例，即减肥后体重增加不超过几磅。使用这一严格的衡量标准来解释试验结果，迫使我们专注于随着时间的推移稳定每个人的体重轨迹，并保持稳定的生活习惯模式。其次，我们认为，在迄今为止以坚持为重点的体重管理试验中，一个重要的动机结构被忽视了--人们是否真的喜欢在日常生活行为中参与，而不考虑他们可能获得的任何长期好处。这种忽视是有问题的，因为在现实世界中，快乐是生活方式行为(如体力活动)长期变化的最强预测因素之一。根据我们之前的工作，这项随机试验将测试在减肥前服用的新模块的真实效果和成本效益，明确旨在提高生活方式行为的乐趣，而不受任何长期健康影响的影响，从而大幅提高长期体重减轻=7%的个人比例。患有高血压前期的超重/肥胖患者将随机接受两种为期12个月的体重管理干预措施(愉悦模块优先或慧俪轻体)之一，并在干预接触结束后24个月进行跟踪。这个应用程序有两个具体的目标，每个目标都集成了一个创新的统计方法：目标1：测试愉悦模块优先是否比慧俪轻体更有效。我们寻求将超重/肥胖成年人达到新指标的比例增加两倍，从15%增加到45%。我们将进行四项实地实验，旨在最大限度地发挥个人准备模块对四种关键生活习惯(体重、营养、活动和 自我培养)；简化模块；并在干预试验中测试它们的协同效力。对于主要目的，我们将测试一个固定效应的中介-干预交互模型，该模型具有足够的交互先验能力。目标2：测试Elevation模块优先是否比慧俪轻体更具成本效益。为了解决先前成本效益分析中的局限性，我们将使用基于代理的建模，这是一种新颖的系统科学建模方法，将来自拟议试验的丰富的个人水平体重轨迹数据与大量国家级心血管数据集集成在一起，以估计我们的两种干预措施对不同受影响美国亚人群在生命过程中的长期、人群水平的高血压和心血管疾病发病率、医疗保健和残疾成本以及质量调整后的寿命年的影响。

 DESCRIPTION (provided by applicant): To powerfully impact the design and success of behavioral weight-management intervention trials that drive the field of obesity treatment, we propose two significant advances. First, we set a new metric for successful weight loss maintenance that is both clinically and behaviorally meaningful-the proportion of individuals who lose =7 percent of initial weight and keep their weight stable over time, i.e., do not gain more than a few pounds after losing weight. Using this demanding metric to interpret trial results forces us to focus on stabilizing each individual's weight trajectory over time and on sustaining stable patterns of lifestyle habits. Second, we contend that an essential motivational construct has been neglected in the adherence-focused weight-management trials to date-whether people actually enjoy engaging in the lifestyle behaviors on a day-to-day basis, regardless of any long-term benefits they may receive. This neglect is problematic as enjoyment is one of the strongest predictors in real-world settings of long-term changes in lifestyle behaviors such as physical activity. Informed by our prior work, this randomized trial will test the real world efficcy and cost-effectiveness of novel modules administered prior to weight loss explicitly designed to enhance enjoyment of lifestyle behaviors independent of any longer-term health effects, and thus substantially escalate the proportion of individuals sustaining =7 percent weight loss over the long-term. Overweight/obese individuals with prehypertension will be randomized to one of two 12-month weight-management interventions (Enjoyment Modules First or Weight Watchers) and followed 24 months after intervention contact ends. This application has two specific aims, each integrating an innovative statistical approach: Aim 1: Test whether Enjoyment Modules First is more efficacious than Weight Watchers. We seek to triple the proportion of overweight/obese adults who achieve the new metric-from 15 percent to 45 percent. We will conduct four field experiments designed to maximize the potency of individual 'prep' modules on the posited mediator of enjoyment for four key lifestyle habits (weighing, nutrition, activity, and self-nurturing); streamline the modules; and test their synergistic potency in the intervention tril. For the primary aim, we will test a fixed effects mediator-intervention interaction model with sufficient a priori power for the interaction. Aim 2: Test whether Enjoyment Modules First is more cost effective than Weight Watchers. To address limitations in prior cost-effectiveness analyses, we will use agent-based modeling, a novel systems science modeling approach to integrate rich individual-level weight-trajectory data from the proposed trial with numerous national-level CVD data sets to produce estimates of the effect of our two interventions on long- term, population-level hypertension and cardiovascular disease incidence, health care and disability costs, and quality-adjusted life-years among different affected US subpopulations over the life course.