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新的指标，这在临床上和行为上都有意义--减掉≥ 7%的初始体重并随着时间的推移保持体重稳定的个体比例，即，减肥后不要增加超过几磅。使用这个苛刻的指标来解释试验结果迫使我们专注于稳定每个人的体重轨迹，并维持稳定的生活习惯模式。第二，我们认为，在迄今为止的以坚持为中心的体重管理试验中，一个重要的动机结构被忽视了人们是否真的喜欢每天从事这种生活方式的行为，而不管他们可能获得的任何长期利益。这种忽视是有问题的，因为享受是现实世界中生活方式行为（如体育活动）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给予的新模块的真实的世界功效和成本效益，这些模块明确旨在增强生活方式行为的享受，而不受任何长期健康影响，从而大幅提升长期体重减轻≥ 7%的个体比例。患有高血压前期的超重/肥胖个体将被随机分配至两种为期12个月的体重管理干预措施之一（首先是享受模块或体重观察者），并在干预接触结束后随访24个月。这个应用程序有两个特定的目标，每个目标都集成了一个创新的统计方法：目标1：测试Enjoyment Modules First是否比Weight Watchers更有效。我们寻求将达到新指标的超重/肥胖成年人的比例从15%提高到45%。我们将进行四个实地实验，旨在最大限度地发挥个人的“准备”模块的效力，对四个关键的生活习惯（体重，营养，活动， 自我培养）;简化模块;并在干预试验中测试其协同效力。对于主要目标，我们将测试一个固定效应的中介-干预交互作用模型，该模型具有足够的交互作用先验能力。目标2：测试享受模块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的局限性，我们将使用基于代理的建模，这是一种新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水平CVD数据集相结合，以估计我们的两种干预措施对长期人群高血压和心血管疾病发病率，医疗保健和残疾成本的影响，和生命过程中不同受影响的美国亚群之间的质量调整生命年。

 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.