The ELM lifestyle treatment for sustained remission of metabolic syndrome
Problem. Prevalence of metabolic syndrome (MetS) increased from 25% to 42% of the U.S. adult population over 8 years(1) and has now become a global epidemic.(2) 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 produced benefits but with limited sustainability without continued treatment.(3)
Methods. The ELM multi-site efficacy trial is an individually randomized, partially clustered trial of 618 participants with the MetS recruited from 5 U.S. sites.(4) A 6-month, habit-based treatment aims to promote 4 automatic habits: vegetables at most meals, daily brisk walks, attention to sensory qualities of food and the environment, and a pause before reacting emotionally to triggers.(5) Intensive treatment of 6 months is followed by 18 monthly maintenance contacts. Outcomes are evaluated at 6 and 24 months. All participants receive education and Fitbits. The 306 randomized to treatment meet in small groups; the 312 randomized to the comparator receive mailed educational tip sheets.
Results. To achieve the cohort of 618 participants,14,817 were screened over 2.5 years. The mean age was 55.5 years, 24.3% were male, 25.5% were a racial minority, and 83.0% were obese (body mass index >30). At the interim 6-month point, completion rates for all variables were 85-92%, weight loss of >5% occurred in 41.8% of treated and 15.6% of comparator (p<0.05), and habit change occurred for all habits except emotional reactivity.
Conclusions. The geographic and sociodemographic diversity of the cohort and 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 MetS remission. If so, it could help to curb a significant and growing international health problem.