Enhancing Lifestyles in the Metabolic Syndrome (ELM) Multi-Site Behavioral Efficacy Trial. Design and Baseline Cohort

Prevalence of metabolic syndrome (MetS) increased from one-quarter to one-third of the United States (U.S.) adult population over 8 years. Diagnosed when ≥3 out of 5 cardiometabolic risk factors are present, there is widespread agreement that its fundamental roots are in a lifestyle characterized by poor dietary quality and physical inactivity. Past lifestyle trials for patients with MetS have produced benefits but limited sustainability of them over time, suggesting a need for new treatment approaches. This report presents the design and baseline cohort of the Enhancing Lifestyles in the Metabolic Syndrome (ELM) multi-site trial. Drawing on a novel habit-based strategy for sustaining behavior change, the trial tests the hypothesis that a 6-month intensive program followed by 18 monthly maintenance contacts can produce 4 new diet, physical activity, and mindfulness habits and, if so, sustained remission of the MetS. This is an individually randomized, partially clustered group treatment trial of 618 participants with the MetS recruited from 5 sites in the U.S. and randomized to a small group lifestyle treatment or an enhanced standard of care comparator. The primary outcome is MetS remission at 24 months. Secondary outcomes compare arms at 6, 15, and 24 months on MetS components, lifestyle targets, weight, body mass index, hemoglobin A1c, LDL cholesterol, medications, quality of life, psychosocial factors, and cost-effectiveness. The baseline cohort of 618 participants was recruited by screening 14,817 over 2.5 years (screening to enrollment ratio 24:1). Recruitment exceeded the target of 600 despite 2 COVID-19 pauses. The mean age of the cohort was 55.5 years, 24.3% were male, 25.5% were a racial minority, 9.7% identified as Hispanic, and 83.0% were classified as obese (body mass index ≥30). The most common MetS components were abdominal obesity (97.7%) and elevated blood pressure/antihypertensive medication (86.2%). The geographic, sociodemographic, and clinical diversity of the cohort combined with rigorous behavioral efficacy trial methods will provide a conclusive answer to the question of whether this habit-based lifestyle program can produce sustained 2-year remission of the MetS and thereby help to curb a significant and growing public health problem.