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

描述（由研究者提供）：本申请涉及广泛的挑战领域（04）临床研究和特定的挑战主题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。虽然50年前只是一个小的公共卫生问题，但超重/肥胖现在已经通过对血压，胰岛素抵抗和脂质的影响成为CVD风险的主要贡献者。幸运的是，即使是适度的体重减轻也可以改善这些风险因素，并且设计良好的当代行为干预通常会使1/2至2/3的参与者在6个月内体重减轻。然而，为了降低CVD发病率和死亡率，体重减轻必须长期持续（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体重减轻维持策略。开发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点之一。减肥维持试验（WLM）是一项多中心、随机、对照试验，比较了高危成人维持减肥的策略。WLM参与者是1032名超重/肥胖成年人（38%的非洲裔美国人，37%的男性），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（I期）中实现了临床显著的体重减轻。这些参与者被随机分配到两个行为干预或无治疗控制条件之一。II期干预在随机化后持续21/2年（从初始体重减轻开始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%的参与者保持了临床显著的体重减轻。第二阶段结束后，妇女解放运动的供资结束。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，将随访时间延长至II期开始后共5年。收集这些后续数据的目的是希望将来能够获得用于分析的资金。为此，该申请要求提供资金，以分析和传播五年的后续数据。这些分析将提供一个难得的机会，以确定和比较短期（6个月），中期（随机化后2 1/2年）和长期（随机化后5年）复发和维持在一个大的和种族多样化的参与者组的预测因素。特别令人感兴趣的是，在成功维持2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，这项工作可以在两年的时间内完成，同时解决ARRA的就业目标。对抗肥胖流行病的最大挑战是开发更好的方法来帮助已经减肥的人保持多年的减肥效果。这项挑战拨款申请要求提供资金，以分析在一项主要研究结束后2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，以确定和比较短期（6个月），中期（随机化后2 1/2年）和长期（随机化后5年）的预测因素的维持在一个大的和种族多样化的参与者群体。

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.