A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome.

描述(申请人提供)：大约34%的美国成年人口符合代谢综合征(METS)的标准，代谢综合征是一系列危险因素，包括腹型肥胖、高血压、血脂异常和糖尿病前期。甲硫氨酸对少数民族有不同的影响，使糖尿病的风险增加五倍，并使心血管疾病(CVD)的风险增加一倍，特别是心力衰竭。改变生活方式是治疗的第一步，但很少有研究表明早期和持续的疗效在缓解METS。我们对大都会医院患者生活方式选择的初步研究包括一个由医学和行为科学专家组成的跨学科团队进行的为期一年的干预。然后，我们在一项准实验性的、仅限治疗的概念验证研究中测试了干预的有效性。在26例METS患者中，我们实现了1年后METS缓解50%的目标。拟议的项目将招募168名METS患者，按1：1的比例随机分配到治疗组或教育控制组，并在12个月和24个月时评估结果。这种疗法被称为榆树(“Eat Well”、“Love Better”、“Move More”)，有几个创新的组成部分：(1)注重代谢、人体测量、行为和心理社会失衡共同变化的文化敏感教育项目；(2)在自然环境中加强发现和自我选择实验的教学方法；以及(3)建立在 通过社交网络的出现提供同行支持。ELM方案由36个小组会议组成，每个小组会议在两年内由大约12名患者组成，由临时电话支持。每次会议的特点是进行体育锻炼，一起做饭，一起分享晚餐。教育控制部门将参加9个季度的健康教育教学课程。双方都将在时事通讯中接受关于大都会的标准教育。主要目标是确定接受治疗的患者组中至少有40%的患者和教育对照组患者中不超过15%的患者在1年后能够缓解大都会歌唱艺术学院的病情。次要目标侧重于：(1)24个月后效果的可持续性；(2)蔬菜、脂肪和碳水化合物摄入、体力活动和感知压力的中间结果；(3)身体质量指数、活力和社会网络变化的次要结果。探索性目标包括开发一个监测成本的系统，探索潜在的心脏代谢生物标志物，该方案的可接受性和可行性，以及作为治疗效果调节因素的建筑和食物环境。评估在基线、12个月和24个月进行，但安全性和成本将每3个月评估一次。这项先导性研究旨在确定ELM干预是否值得在更严格的疗效试验中进行后续测试。支持对METS进行有效和具有成本效益的生活方式治疗，可以为降低心脏代谢风险提供一个可行的选择。

DESCRIPTION (provided by applicant): Approximately 34% of the US adult population meet criteria for the metabolic syndrome (MetS), a cluster of risk factors that include abdominal obesity, elevated blood pressure, dyslipidemia, and pre-diabetes. MetS differentially affects ethnic minorities, quintuples the risk of diabetes, and doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle modification is the initial step of treatment but few studies have demonstrated early and sustained efficacy in remission of the MetS. Our preliminary studies of a lifestyle option for patients with the MetS included a 1-year of development of an intervention by an interdisciplinary team of experts in medicine and the behavioral sciences. We then tested the efficacy of the intervention in a quasi-experimental, treatment-only, proof-of-concept study. In 26 patients with the MetS, we achieved our goal of 50% remission of the MetS after 1 year. The proposed project will recruit 168 patients with the MetS, randomize them in a 1:1 ratio to either a treatment or an education control arm, and assess outcomes at 12 and 24 months. The treatment, called ELM ("Eat well", "Love better", "Move More"), features several innovative components: (1) an culturally sensitive education program that focuses on the co-variation of metabolic, anthropometric, behavioral, and psychosocial imbalances; (2) a method of teaching that enhances discovery and self-chosen experimentation within a naturalistic setting; and (3) an approach to sustainability that builds on peer support via the emergence of a social network. The ELM protocol consists of 36 group meetings of approximately 12 patients each over 2 years supported by interim phone calls. Each meeting features physical activity, cooking together, and sharing dinner together. The Education Control arm will participate in 9 quarterly health education didactic classes. Both arms will receive standard education about the MetS in newsletters. The primary aim is to determine if at least 40% in the treated arm, and no more than 15% of the education control arm, will achieve remission of the MetS after 1 year. Secondary aims focus on: (1) the sustainability of the effects at 24 months; (2) the intermediate outcomes of vegetable, fat and carbohydrate intake, physical activity, and perceived stress; and (3) the secondary outcomes of body mass index, vitality, and change in the social network. Exploratory aims include development of a system for monitoring costs, exploring potential cardio metabolic biomarkers, the acceptability and feasibility of the protocol, and built and food environment as moderators of treatment effects. Assessments occur at baseline, 12 months, and 24 months except for safety and costs which will be assessed every 3 months. This pilot study is intended to determine whether or not the ELM intervention merits subsequent testing in a more rigorous efficacy trial. Support for an efficacious and cost-effective lifestyle treatment for the MetS could provide a viable option for reducing cardio metabolic risk.