NCT04036006

Enhanced Lifestyles for Metabolic Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Group-Based Program	The Group-based Program uses an ecologically valid setting in which participants exercise, prepare foods, and eat together to facilitate the emergence of old habits and replace them with healthy alternatives. The intervention team consists of a health psychologist, registered dietitian, and health coach. They co-facilitate group meetings for 15 participants that are held weekly for 3 months, bi-weekly for 3 months, and then monthly in participant-led maintenance meetings. Each session includes: weigh-in and physical activity (20 min), cooking demonstration (20 min), and a shared vegetable dish with discussion (50 min). The maintenance phase (months 7 to 24 post randomization) consists of support and health-related topics of the participants' own choosing. Progress reports with lab results are sent to participants and primary care physicians.
BEHAVIORAL	Self-Directed Program	The Self-Directed lifestyle program represents enhanced usual care based upon what is currently offered in primary care in the United States for lifestyle treatments for adults with metabolic syndrome. Usual care is enhanced by: 1) lifestyle education for management of metabolic syndrome provided in evidence-based tip sheets from nationally recognized organizations; 2) provision of a Fitbit for self-monitoring physical activity; 3) access to a website containing all education materials; and 4) progress report letters with lab results sent to participants and primary care physicians after completion of each assessment.

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2019-07-29
• Last updated: 2024-06-11

Locations

5 sites across 1 country: United States