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

描述（由申请人提供）：大约34%的美国成年人符合代谢综合征（MetS）的标准，代谢综合征是一组危险因素，包括腹部肥胖、血压升高、血脂异常和糖尿病前期。met对少数民族的影响不同，患糖尿病的风险增加五倍，心血管疾病（CVD）的风险增加一倍，特别是心力衰竭。生活方式的改变是治疗的第一步，但很少有研究表明早期和持续的疗效缓解的大都会。我们对MetS患者生活方式选择的初步研究包括由医学和行为科学领域的跨学科专家团队进行的为期一年的干预开发。然后，我们在一项准实验、仅治疗、概念验证研究中测试了干预措施的有效性。在26例met患者中，我们在1年后达到了50%的met缓解目标。拟议的项目将招募168名met患者，以1:1的比例随机分配到治疗组或教育对照组，并在12个月和24个月时评估结果。这种治疗被称为ELM（“吃得好”、“爱得更好”、“多动”），它有几个创新的组成部分：(1)一个文化敏感的教育计划，重点关注代谢、人体测量、行为和社会心理失衡的共同变异；(2)在自然环境中加强发现和自主选择实验的教学方法；(3)建立在可持续发展基础上的方法

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.