WEIGHT LOSS MAINTENANCE TRIAL

描述(由申请人提供)： 在美国，超重/肥胖是第二大死亡原因，而且患病率正在以惊人的速度增长。控制超重/肥胖越来越被认为是国家的高度优先事项，因为它对心血管(CVD)风险因素并最终对CVD本身有贡献。减肥行为干预的短期成功已被反复记录在案。不幸的是，因为体重重新增加是非常普遍的，令人失望的是，有一小部分人实现了长期的体重控制。在与持续减肥相关的因素中，最重要的因素之一是经常接触的持续干预。我们提出了一项多中心、随机、对照试验[减肥维持试验(维护)]，以确定两种创新的行为干预措施的效果，每种干预措施都旨在保持与普通护理控制组的频繁接触。超重和肥胖的个人(大约60%的女性，大约40%的非裔美国人)正在服用治疗高血压、血脂异常和/或2型糖尿病的药物，他们将参加为期6个月的减肥计划。这些减重至少4公斤(N=800)的人将被随机分为三组：个人接触(PC)干预，每月与训练有素的干预者进行个人接触，主要通过电话；互动技术(IT)干预，通过最先进的基于网络的互动程序，辅之以其他通信技术，提供频繁接触；或日常护理(UC)。主要结果将是从最初减肥计划结束到30个月体重维持干预期结束的体重变化。其他结果将包括亚组中体重的变化、心血管疾病风险因素的流行、行为变化的衡量标准以及实施成本。对于每个结果，PC和IT干预将与UC进行比较，如果与UC不同，则相互比较。为了成功地抗击肥胖症流行，临床医生和卫生保健系统必须有有效和可行的选择，并且可以提供给大量个人。这项提议的目的是开发和测试两种此类干预措施，如果有效，应补充正在进行的遏制肥胖症流行并最终预防与肥胖症相关的心血管疾病的努力。

DESCRIPTION (provided by applicant): Overweight/obesity is the second leading cause of death in the US, and is growing in prevalence at an alarming rate. Control of overweight/obesity is increasingly recognized as a high national priority because of its contribution to cardiovascular (CVD) risk factors and ultimately to CVD itself. The short-term success of behavioral interventions for weight loss has been repeatedly documented. Unfortunately, because weight re-gain is extremely common, a disappointingly, small proportion of individuals achieve long-term weight control. Of the factors that are associated with sustained weight loss, one of the most important is continued intervention with frequent contacts. We propose a multi-center, randomized, controlled trial [Weight Loss Maintenance Trial (MAINTENANCE)] to determine the effects of two innovative behavioral interventions, each designed to maintain frequent contacts, compared to a usual care control group. Overweight and obese individuals (approximately 60% women, approximately 40% African Americans) who are taking medication for hypertension, dyslipidemia and/or type 2 diabetes will enter a 6-month, weight loss program. Those individuals who lose at least 4 kg (N = 800) will then be randomized into one of three groups: a Personal Contact (PC) Intervention that provides monthly personal contacts with a trained interventionist, primarily via telephone; an Interactive Technology (IT) Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies; or Usual Care (UC). The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period. Other outcomes will include weight change in subgroups, prevalence of CVD risk factors, measures of behavior change, and cost of implementation. For each outcome, the PC and IT interventions will be compared to UC and, if different from UC, to each other. To successfully combat the obesity epidemic, clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals. The purpose of this proposal is to develop and test two such interventions, which, if effective, should complement ongoing efforts to stem the obesity epidemic and ultimately prevent obesity-related CVD.