Enhancing Lifestyles in the Metabolic syndrome (ELM) multisite behavioral efficacy trial. Design and baseline cohort

Abstract

Background: Prevalence of metabolic syndrome (MetS) increased from one-quarter to one-third of the U.S. adult population over 8 years and is spreading to young adults and Asian and Hispanic Americans. 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 MetS produce benefits that have limited sustainability, suggesting the need for new treatment approaches.

Methods: This is the design and baseline cohort of the Enhancing Lifestyles in the Metabolic Syndrome (ELM) multi-site trial. The trial tests the hypothesis that a habit-based lifestyle treatment offered over 6 months, followed by 18 monthly maintenance contacts, can produce 4 new diet, physical activity, and mindfulness habits and, if so, sustained MetS remission. The design 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 education 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.

Results: The 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 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 or antihypertensive medication (86.2%).

Conclusions: 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 24-month remission of the MetS and thereby help to curb a significant and growing public health problem.