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

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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.