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

描述（由研究者提供）：该申请涉及广泛的挑战领域（04）临床研究，以及特定的挑战主题04- hl -104：对现有数据进行二次分析，以回答重要的临床和预防医学研究问题。50年前，超重/肥胖只是一个小的公共健康问题，而现在，超重/肥胖通过对血压、胰岛素抵抗和血脂的影响，已成为心血管疾病风险的主要因素。幸运的是，即使是适度的减肥也能改善这些危险因素，设计良好的当代行为干预通常会使1/2到2/3的参与者在6个月的时间里体重显著减轻。然而，为了降低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超过一年的减肥维持策略。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问题之一。体重减轻维持试验（WLM）是一项多中心、随机、对照试验，比较了高危成人维持体重减轻的策略。WLM的参与者是1032名超重/肥胖的成年人（38%是非裔美国人，37%男性），他们服用高血压和/或血脂异常药物，在最初的6个月减肥计划（第一阶段）中取得了临床显著的体重减轻。这些参与者被随机分配到两种行为干预中的一种或不进行治疗的对照组。II期干预在随机化后持续2年半（从开始减重开始算起3年）。在II期结束时，随访数据收集率超过90%，每个治疗组中有40- 46%的参与者保持了临床显着的体重减轻。WLM的资金在第二阶段结束后终止。然而，4个临床中心中的3个继续进行干预活动，并收集了另外2年半的随访数据，在II期开始后将随访时间延长至5年。收集这些后续数据的目的是希望将来能够获得分析这些数据的资金。为此目的，本申请书要求供资，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识别和比较短期（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，是否有必要继续干预以维持体重减轻。由于数据已经收集，这项工作可以在2年的时间框架内完成，同时解决ARRA的就业目标。与肥胖流行病作斗争的最大挑战是找到更好的方法来帮助那些已经减肥的人多年来保持减肥效果。这项挑战拨款申请要求资助分析一项主要研究结束后两年半收集的随访数据，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识别和比较短期（6个月）、中期（随机化后2年半）和长期（随机化后5年）在一个大的、种族多样化的参与者群体中的维持预测因素。

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.