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

NCT04637477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Missouri, Kansas City

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Geisinger Clinic

    collaborator OTHER

  • Rochester Institute of Technology

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Lynda Powell, PhD · Rush University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2020-12-31
Completion
2021-08-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04637477 on ClinicalTrials.gov