Lifestyle Program Sustains Metabolic Syndrome Remission

Key Takeaways

• Higher metabolic syndrome remission was observed with the intervention at both early and longer-term follow-up.
• Selected secondary differences remained at 24 months, including fasting glucose and several lifestyle measures.
• No adverse events were tied to trial participation, and the comparison was made against an active education-and-monitoring program.

Adults with metabolic syndrome who received a habit-based lifestyle program had more sustained remission than peers receiving education plus activity monitoring, an active comparator rather than an inactive control. The difference translated to about 15 participants receiving the added program for 1 additional remission. That advantage was still present at the prespecified 24-month assessment, well after the active 6-month intervention ended.

In the ELM single-blind, individually randomized JAMA Internal Medicine randomized clinical trial, investigators enrolled adults with metabolic syndrome who were motivated for lifestyle change at 5 US sites. Among 618 analyzed participants, randomization was 1:1 and stratified by site; mean age was 55.5 years, 74.7% were female, and obesity was present in 83.0%. The prespecified primary outcome was metabolic syndrome remission at 24 months, assessed with blinded laboratory evaluation and clinical examination. Follow-up at 24 months was completed by 517 of 618 participants, or 83.7%, completing the main efficacy assessment.

Both study groups received shared education about metabolic syndrome and a Fitbit activity monitor. The intervention group also attended 19 in-person group meetings over 6 months and had individual dietary consultations at baseline and 6 months. Afterward, that group could join monthly support meetings that offered no new content. The comparator group received 24 monthly evidence-based educational mailings and telephone contact every 3 months. Targets included vegetables at meals, daily brisk walks, sensory awareness, and emotion regulation.

At 6 months, remission occurred in 76 of 306 participants (24.8%) in the intervention group and 56 of 312 (17.9%) in the comparator group. The adjusted odds ratio was 1.64 (95% CI, 1.07-2.53; P=.03), and at 24 months remission was 85 of 306 (27.8%) versus 66 of 312 (21.2%). The adjusted odds ratio at 24 months was 1.46 (95% CI, 1.01-2.14; P<.05), and fasting glucose was 97.7 versus 100.7 mg/dL, with an adjusted effect size of −2.74 (95% CI, −5.31 to −0.16; P=.04). Sustained differences also favored vegetable intake, daily steps, sensory awareness, and daily brisk walks. Many cardiometabolic and lifestyle measures improved at 6 months, but longer-term differences were concentrated in these behavioral and metabolic measures.

Intervention fidelity was excellent, and satisfaction at 24 months was higher in the intervention arm than in the comparator arm. Safety monitoring involved 437 blinded adjudications, including 115 serious adverse events, 290 adverse events, and 32 nonevents, with no events determined to be related to trial participation.

The authors described the 24-month effect as modest, noted a wide confidence interval, and said the active comparator and nonspecific attention may have contributed. Paused, hybrid, or socially distanced meetings during COVID-19 also may have diluted effects. Under trial conditions, the program was associated with a modest sustained remission advantage, while routine implementation and cost-effectiveness remained unresolved.