WEIGHT LOSS MAINTENANCE TRIAL

描述（由申请人提供）： 超重/肥胖是美国的第二大死亡原因，并且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一个高度优先事项，因为它会导致心血管（CVD）风险因素，并最终导致CVD本身。行为干预减肥的短期成功已经被反复记录。不幸的是，由于体重重新增加是非常普遍的，令人不安的是，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。我们提出了一个多中心，随机，对照试验[减肥维持试验（维护）]，以确定两个创新的行为干预措施的效果，每一个旨在保持频繁的接触，与常规护理对照组相比。正在服用高血压、血脂异常和/或2型糖尿病药物的超重和肥胖个体（约60%女性，约40%非裔美国人）将进入为期6个月的减肥计划。那些体重至少减轻4公斤的人（N = 800）将被随机分为三组：个人接触（PC）干预，主要通过电话，每月与训练有素的干预人员进行个人接触;互动技术（IT）干预，通过最先进的互动式网络程序，辅以其他通信技术，提供频繁的接触;或护理（UC）。主要结果是从初始减肥计划结束到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的体重变化，CVD危险因素的患病率，行为变化的测量和实施成本。对于每种结局，将PC和IT干预与UC进行比较，如果与UC不同，则相互比较。为了成功地对抗肥胖流行病，临床医生和卫生保健系统必须有有效和可行的选择，并可以提供给大量的个人。这项提案的目的是开发和测试两种这样的干预措施，如果有效，应该补充正在进行的努力，以遏制肥胖流行病，并最终预防肥胖相关的心血管疾病。

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 (-60% women, -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.