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Virtual Enhanced Lifestyle for Metabolic Syndrome (ELM) Proof-of-Concept Study | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT04637477•Rush University Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Men and women with components of the metabolic syndrome, defined by an adapted version of the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO (Alberti, 2009). Surrogates for waist circumference and fasting glucose were selected to help identify prospective participants using medical records. Participants must have ≥ 2 of the following five criteria to participate in the study:
•* Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women or BMI≥30
•* Triglycerides ≥150 mg/dL or treatment for elevated triglycerides
•* HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or treatment for low HDL
•* Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension
•* Fasting plasma glucose 100-125 mg/dL (range inclusive), or on metformin, or HbA1c between 5.7 and 6.4.
•2. Age 18 years or older
•3. Highly motivated to make lifestyle changes as a way to manage the MetS.

Exclusion Criteria

•1. Individuals who report being unable to walk 2 consecutive blocks without assistance are ineligible. Additionally, individuals who endorse pain, tightness, or pressure in their chest during physical activity (on question 1 of the EASY screener) or current dizziness or lightheadedness (on question 2 of the EASY screener) may not be randomized without providing documentation in writing from their physician indicating that they have been cleared for participation in the trial.
•2. Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
•3. BMI \<27 or \> 40
•4. Weight \> 397 lbs. The Fitbit Aria scale, utilized in the intervention, measures up to 397 lbs.
•5. Unable to consistently attend group classes at the anticipated time due to schedule conflicts or other reasons.
•6. Unable or unwilling to give an informed consent or communicate with study staff.
•7. Unable or unwilling to complete accelerometer data collection.
•8. Does not have reliable access to the internet.
•9. Does not have a smart phone. Must be willing to download the Fitbit app on their smart phone.
•10. Not fluent in English
+20 more criteria

Locations (2)

Rush University Medical Center

Chicago, Illinois, United States

University of Missouri-Kansas City School of Medicine

Kansas City, Missouri, United States

Key Dates

Start Date

August 1, 2020

Primary Completion Date

December 31, 2020

Completion Date

August 25, 2021

Last Updated

September 16, 2021

Enrollment

ACTUAL participants

Conditions

Metabolic SyndromeObesity

Interventions

Virtual ELM

BEHAVIORAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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