PREMIER Maintenance Trial

PREMIER 维护试用

• 批准号: 6573009
• 负责人: PATRICIA J. ELMER
• 金额: $ 61.67万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-15 至 2007-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6573009
• 关键词: Internet; behavior therapy; behavioral /social science research tag; clinical research; clinical trial phase III; computer assisted instruction; computer assisted patient care; cooperative study; human subject; human therapy evaluation; obesity; patient oriented research; social facilitation; telemedicine; weight control; weight loss

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.

描述（由申请人提供）： 超重/肥胖是美国第二大死亡原因，并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，因为它会导致心血管 (CVD) 危险因素并最终影响 CVD 本身。行为干预减肥的短期成功已被多次记录。不幸的是，由于体重重新增加极为常见，令人失望的是，只有一小部分人实现了长期体重控制。在与持续体重减轻相关的因素中，最重要的因素之一是频繁接触的持续干预。我们提出了一项多中心、随机、对照试验[减肥维持试验（MAINTENANCE）]，以确定两种创新行为干预措施的效果，每种干预措施旨在与常规护理对照组相比保持频繁接触。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% 为女性，约 40% 非裔美国人）将进入为期 6 个月的减肥计划。那些减重至少 4 公斤（N = 800）的个体将被随机分为三组之一： 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；交互式技术（IT）干预，通过最先进的交互式网络程序并辅以其他通信技术来提供频繁的联系；或常规护理 (UC)。主要结果是从最初减肥计划结束到 30 个月体重维持干预期结束时的体重变化。其他结果将包括亚组的体重变化、CVD 危险因素的患病率、行为变化的衡量标准以及实施成本。对于每个结果，PC 和 IT 干预措施将与 UC 进行比较，如果与 UC 不同，则相互比较。为了成功对抗肥胖流行病，临床医生和卫生保健系统必须拥有有效、可行且可以向大量个体提供的选择。该提案的目的是开发和测试两种此类干预措施，如果有效，这将补充正在进行的遏制肥胖流行的努力，并最终预防与肥胖相关的心血管疾病。