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Enhanced Lifestyles for Metabolic Syndrome — ELM  

Metabolic Syndrome Clinical Trial

Official title:
A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome

Clinical Trial Summary

This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention on remission of the metabolic syndrome over 2 years of follow-up.

Clinical Trial Description

The purpose of this trial is to determine the efficacy and cost-effectiveness of the Group-Based and Self-Directed ELM lifestyle programs when offered on a national level. A multi-site randomized trial will be conducted on 600 patients with the metabolic syndrome (MetS) by five national sites, each of which will randomize 120 patients to the Group-Based or Self-Directed programs. The Group-Based program targets healthy eating, physical activity, and stress reduction and is based upon neuroscience studies showing that mindful habits provide resilience against the power of emotions to subvert intention, and social science studies showing that sustainability is enhanced by support from a health network. The Self-Directed program represents enhanced usual care based upon what is currently offered in medicine and wearable technology for treatment of adults with MetS and its components. The primary outcome is remission of MetS at 2 years. Secondary outcomes include cost-effectiveness, vegetable intake, physical activity, and mindful awareness. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04036006
Study type Interventional
Source Rush University Medical Center
Contact
Status Completed
Phase N/A
Start date July 1, 2019
Completion date March 29, 2024
View Details
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