NCT04637477

Virtual Enhanced Lifestyle for Metabolic Syndrome (ELM) Proof-of-Concept Study

Rush Coronavirus Disease Virtual Lifestyle Program to Boost Host Resistance in Patients With Elevated Cardiometabolic Risk: A Proof-of-Concept Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a proof-of-concept study of a virtual version of a lifestyle intervention aimed at reducing cardiometabolic risk in patients with the Metabolic Syndrome (MetS). The aim is to recruit 12 patients at high risk for coronavirus infection based upon a diagnosis of obesity and the MetS, conduct a 12-week virtual version of the in-person intervention, and explore efficacy using clinically significant pre-specified targets for weight, diet, physical activity, stress, and markers of inflammation. In addition, the investigators will explore safety, fidelity, feasibility, and acceptability.

Conditions

• Metabolic Syndrome
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Virtual ELM	Participants will attend 1.5-hour virtual group-based sessions for 12 weeks. The program includes physical activity, cooking demonstrations, and group discussions. All sessions are led by a registered dietitian and health psychologist.

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-31
• Completion: 2021-08-25
• First posted: 2020-11-19
• Last updated: 2021-09-16

Locations

2 sites across 1 country: United States