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

减肥维持试验五年随访数据分析

• 批准号: 7937742
• 负责人: Victor J Stevens
• 金额: $ 49.71万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937742
• 关键词: Address; Adult; African American; Applications Grants; Area; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Body Weight Changes; Body Weight decreased; Clinical; Clinical Research; Clinical Trials; Control Groups; Controlled Clinical Trials; Data; Data Analyses; Data Collection; Development; Direct Costs; Dyslipidemias; Employment; Epidemic; Funding; Future; Goals; Hypertension; Individual; Insulin Resistance; Internet; Intervention; Lipids; Maintenance; Minor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Obesity; Outcome; Overweight; Participant; Pharmaceutical Preparations; Phase; Population; Prevalence; Preventive Medicine; Public Health; Randomized; Randomized Controlled Trials; Relapse; Request for Applications; Research; Research Personnel; Resources; Risk; Risk Factors; Self-control as a personality trait; Testing; Time; Weight; active method; arm; base; clinically significant; collected works; data management; design; fighting; follow-up; high risk; improved; interest; male; meetings; mortality; next generation; obesity treatment; programs; skills; success; symposium; trial comparing; weight loss intervention; weight maintenance

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.

描述（调查员提供）：本申请涉及广泛的挑战领域（04）临床研究以及特定挑战主题04-HL-104：对现有数据进行次要分析，以回答重要的临床和预防医学研究问题。虽然仅50年前就只有一个次要的公共卫生问题，但超重/肥胖现已通过对血压，胰岛素抵抗和脂质的影响而成为CVD风险的主要因素。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，并且精心设计的现代行为干预措施通常会在1/2至2/3的参与者中产生临床上具有显着的6个月体重减轻。但是，为了降低CVD的发病率和死亡率，必须长期持续体重（NHLBI定义为至少5年），并且只有少数对照临床试验系统地比较了一年以上的减肥策略。制定更有效的长期维护策略已成为肥胖治疗领域中最重要的问题之一。减肥维持试验（WLM）是一项多中心，随机，对照的试验，比较了维持高风险成年人体重减轻的策略。 WLM参与者是1032名超重/肥胖成年人（38％的非裔美国人，37％的男性）服用高血压和/或血脂异常药物，他们在最初的6个月减肥计划（I期）中实现了临床上显着的体重减轻。这些参与者被随机分配给两种行为干预措施之一或无治疗控制条件。随机分组后（自初次体重减轻开始3年）后，II期干预持续了21/2年。在第二阶段结束时，以超过90％的随访数据收集率，每个治疗组的参与者中有40-46％保持临床上显着的体重减轻。 WLM的资金在第二阶段之后结束。但是，这4个临床中心中有3个继续干预活动，并收集了2 1/2年的后续数据，将随访延长至II期开始后的5年。收集这些后续数据，希望将来可以获得他们的分析资金。为此，本申请要求资金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来识别和比较短期（6个月），中期（随机分配后2 1/2年）和长期（随机后5年）的复发和维护预测指标，在大型且种族多样的参与者组中。特别有趣的是，在成功维护2 1/2年后，是否需要继续干预才能维持体重减轻。由于已经收集了数据，因此可以在2年的时间范围内完成这项工作，同时解决ARRA的就业目标。与肥胖症患者作斗争的最大挑战是发展更好的方法来帮助减肥的个人多年来保持体重减轻。这项挑战授予申请要求资金分析一项重大研究结束后2 1/2年收集的后续数据，该数据测试了几种不同的减肥策略。这些分析将为识别和比较短期（6个月），中期（随机分配后2 1/2年）和长期（随机后5年）维护的预测指标的罕见机会。