Lifestyle Intervention for Sustained Remission of Metabolic Syndrome: A Randomized Clinical Trial.

Importance: Prevalence of metabolic syndrome (MetS) defined as 3 or more cardiometabolic risk factors has grown to 43% among US adults. Lifestyle interventions produce benefits, but with limited sustainability. Objective: To determine whether a 6-month habit-based lifestyle program adds benefit to education and activity monitoring for sustained MetS remission at 24 months. Design, Setting, and Participants: The Enhancing Lifestyles in Metabolic Syndrome (ELM) study was a single-blind, individually randomized clinical trial of participants with MetS recruited from July 2019 to January 2022 at 5 locations in the US and followed up for 24 months. Eligible participants were motivated for lifestyle change and were contacted using electronic medical records and social or mass media; those who did not meet medical or logistical criteria were excluded. In all, 14 817 adults were screened during a 2.5 year period. Data were analyzed from March 2024 to May 2025. Interventions: All participants received education and an activity monitor. Those in the intervention group also received 19 small group in-person meetings during 6 months, which sought to establish the following habits as part of their daily routine: vegetables at meals, brisk walks, sensory awareness, and emotion regulation. Repetition of these habits was encouraged by attention to participants' experience of immediate benefits and peer support. The comparator group received 24 evidence-based educational mailings monthly during the 24 months. Main Outcome and Measures: MetS remission at 24 months determined by blinded laboratory evaluation and clinical examination. Secondary outcomes were cardiometabolic and lifestyle risk factors at 6 and 24 months. Results: The analysis included 618 participants (mean [SD] age, 55.5 [11.0] years; 468 female [74.7%] and 150 male [24.3%] individuals), of whom 306 (49.5%) were randomized to the intervention and 312 (50.5%) to the comparator. The 24-month follow-up period was completed by 517 participants (83.7%). Obesity, measured by body mass index, was present in 513 participants (83%). At 6 months, the proportion achieving MetS remission was 24.8% in intervention group and 17.9% in comparator (adjusted odds ratio, 1.64; 95% CI, 1.07-2.53; P = .03), supported by improvements in waist circumference, triglycerides, fasting glucose, body mass index, weight, hemoglobin A1c, MetS severity, perceived stress, vegetable intake, moderate-intensity physical activity, daily steps, sensory awareness, and the habits of daily brisk walks and vegetables at meals. At 24 months, the proportion achieving sustained MetS remission was 27.8% (85 of 306 participants) in intervention group and 21.2% (66 of 312) in the comparator (adjusted odds ratio, 1.46; 95% CI, 1.01-2.14; P < .05), supported by sustained improvement in fasting glucose, vegetable intake, daily steps, sensory awareness, and the habit of daily brisk walks. Conclusions and Relevance: This randomized clinical trial found that sustained MetS remission after treatment may be possible by promoting simple habits through a behavior-based lifestyle program focused on immediate benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT04036006.