Analysis of five year follow-up data from the Weight Loss Maintenance Trial

描述(由研究人员提供)：这个应用程序解决了广泛的挑战领域(04)临床研究，以及特定的挑战主题04-HL-104：执行现有数据的二次分析，以回答重要的临床和预防医学研究问题。虽然50年前超重/肥胖只是一个次要的公共卫生问题，但现在通过影响血压、胰岛素抵抗和血脂，超重/肥胖已成为心血管疾病风险的主要贡献者。幸运的是，即使是适度的减肥也会改善这些风险因素，而精心设计的当代行为干预措施通常会使1/2到2/3的参与者在6个月内获得临床上显著的体重减轻。然而，为了减少心血管疾病的发病率和死亡率，减肥必须长期持续(NHLBI定义为至少5年)，只有少数对照临床试验系统地比较了一年以上的减肥维持策略。制定更有效的长期维持策略已成为肥胖治疗领域最重要的关注之一。减肥维持试验(WLM)是一项多中心、随机、对照试验，比较了高危成年人保持减肥的策略。WLM的参与者是1032名超重/肥胖的成年人(38%的非裔美国人，37%的男性)，他们正在服用治疗高血压和/或血脂异常的药物，他们在最初的6个月减肥计划(第一阶段)中实现了临床上显著的减肥。这些参与者被随机分配到两种行为干预中的一种，或者被分配到没有治疗的对照条件下。第二阶段干预在随机化后持续21年半(从开始减肥开始算起3年)。在第二阶段结束时，随访数据收集率超过90%，每个治疗组中有40%-46%的参与者保持着临床上显著的体重减轻。WLM的资助在第二阶段结束。然而，4个临床中心中有3个继续进行干预活动，并收集了另外两年半的随访数据，将随访延长到第二阶段开始后的总共5年。这些随访数据的收集是希望未来能够获得资金用于他们的分析。为此，该应用程序请求提供资金，以分析和传播五年后续数据。这些分析将提供一个难得的机会来确定和比较短期(6个月)、中期(随机化后2年半)和长期(随机化后5年)复发和维持的预测因素。特别令人感兴趣的是，在成功维持两年半后，是否需要继续干预以维持减肥。由于已经收集了数据，这项工作可以在两年的时间框架内完成，同时解决ARRA的就业目标。抗击肥胖症流行的最大挑战是开发更好的方法来帮助减肥的人多年来保持他们的减肥。这项挑战拨款申请申请资金，以分析在一项主要研究结束后两年半收集的跟踪数据，该研究测试了几种不同的减肥维持策略。这些分析将提供一个难得的机会来确定和比较短期(6个月)、中期(随机化后2年半)和长期(随机化后5年)在一个不同种族的大型参与者群体中维持的预测因素。

DESCRIPTION (provided by investigator): This application addresses broad Challenge Area (04) Clinical Research, and specific Challenge Topic 04-HL-104: Perform secondary analyses of existing data to answer important clinical and preventive medicine research questions. While only a minor public health issue 50 years ago, overweight/obesity has now become a major contributor to CVD risk through effects on blood pressure, insulin resistance, and lipids. Fortunately, even modest weight loss improves these risk factors, and well-designed, contemporary behavioral interventions typically yield a clinically significant 6-month weight loss for 1/2 to 2/3 of the participants. To reduce CVD morbidity and mortality, however, weight loss must be sustained long-term (defined by NHLBI as at least 5 years), and only a few controlled clinical trials have systematically compared weight loss maintenance strategies for more than one year. Developing more effective long-term maintenance strategies has become one of the most important concerns in the field of obesity treatment. The Weight Loss Maintenance Trial (WLM) was a multi-center, randomized, controlled trial that compared strategies for maintaining weight loss in high risk adults. WLM participants were 1032 overweight/obese adults (38 percent African American, 37 percent male) taking medication for hypertension and/or dyslipidemia, who achieved a clinically significant weight loss during an initial 6-month weight loss program (Phase I). These participants were randomly assigned to one of two behavioral interventions or to a no-treatment control condition. Phase II intervention continued for 21/2 years after randomization (3 years from the start of initial weight loss). At the end of phase II, with a greater than 90 percent follow-up data collection rate, 40-46 percent of the participants in each treatment group were maintaining clinically significant weight loss. Funding for WLM ended after phase II. However, 3 of the 4 clinical centers continued intervention activities and have collected follow-up data for another 2 1/2 years, extending follow-up to a total of 5 years after the start of phase II. These follow-up data were collected with the hope that funding for their analysis could be obtained in the future. To that end, this application requests funding to analyze and disseminate the five year follow-up data. These analyses will provide a rare opportunity to identify and compare short-term (6 month), intermediate-term (2 1/2 years post randomization) and long-term (5 years post randomization) predictors of relapse and maintenance in a large and racially diverse participant group. Of particular interest is whether continued intervention is necessary to sustain weight loss after 2 1/2 years of successful maintenance. Since the data have already been collected, this work can be accomplished in a 2- year time frame while simultaneously addressing the employment goals of the ARRA. The biggest challenge in fighting the obesity epidemic is developing better ways to help individuals that have lost weight maintain their weight loss over many years. This challenge grant application requests funding to analyze follow-up data collected 2 1/2 years following the end of a major study that tested several different weight loss maintenance strategies. These analyses will provide a rare opportunity to identify and compare short-term (6 month), intermediate-term (2 1/2 years post randomization) and long-term (5 years post randomization) predictors of maintenance in a large and racially diverse participant group.