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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome, Obesity

Intervention / Treatment
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* Behavioral: Virtual ELM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age 18 years or older Highly motivated to make lifestyle changes as a way to manage the MetS. Exclusion Criteria: 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. Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM BMI <27 or > 40 Weight > 397 lbs. The Fitbit Aria scale, utilized in the intervention, measures up to 397 lbs. Unable to consistently attend group classes at the anticipated time due to schedule conflicts or other reasons. Unable or unwilling to give an informed consent or communicate with study staff. Unable or unwilling to complete accelerometer data collection. Does not have reliable access to the internet. Does not have a smart phone. Must be willing to download the Fitbit app on their smart phone. Not fluent in English Current diagnosis of type 1 or type 2 diabetes, on any diabetes medications except metformin, or has a screening A1c ≥6.5 Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness Probable major depression, defined as a PHQ-8 score ≥10 Pregnant women, planning a pregnancy in the next 2 months, given birth in the last 6 months, or currently breastfeeding ≥ 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant Problematic use of alcohol and/or recreational drugs, defined as ASSIST screening score of ≥27. Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years Use of weight loss medications (Qsymia, orlistat, phentermine, Saxenda, etc.) in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the trial History of bowel resection surgery or bariatric surgery Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc) History of major cardiovascular illness, including: a) stroke; b) myocardial infarction; c) congestive heart failure requiring hospitalization, or greater than NYHA heart failure class I; d) uncontrolled hypertension (SBP>180 or DBP > 109); e) unstable angina or an active prescription for sublingual nitroglycerin; or f) other major cardiovascular illness which the site PI determines could limit ability to participate in the trial. Individuals screened for participation, whose screening systolic blood pressure is ≥160 and ≤179, or whose screening diastolic blood pressure is ≥100 and ≤109 are considered to have MODERATE, or Stage 3 Hypertension. If they otherwise qualify and wish to participate in ELM, they will be referred to their physician for clearance prior to randomization. Cognitive impairment Visual or hearing impairment Currently taking or expecting to take any of the following exclusionary medications: Antiretroviral therapy (e.g., HAART) Weight loss medications (as in #14) Medications known to significantly influence weight or metabolic outcomes Diabetes drugs other than metformin (as in #7) Receiving dialysis Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual ELM<br> | Behavioral: Virtual ELM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months. | Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale. | 3 months after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of components of metabolic syndrome | The proportion of participants who are in remission of the metabolic syndrome (MetS) at 3 months will be calculated. MetS is defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO as having 3 or more risk factors for cardiovascular disease. To be considered in remission of MetS the participant must have less than 3 of the following 5 criteria: 1) Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women; 2) Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides; 3) Fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL; 4) Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension; and 5) Fasting plasma glucose 100-125 mg/dL. | Measured at 3 months from baseline | 
| Vegetable consumption | The proportion of participants who eat 2 cups of vegetables per day. This will be assessed using the National Cancer Institute (NCI) Fruit and Vegetable Intake Screener from the Eating at America's Table Study: All Day Screener. | Measured at 3 months from baseline | 
| Physical activity | The proportion of participants who achieve 150 minutes of at least moderate intensity physical activity per week will be calculated. Activity is measured using an accelerometer (Actigraph wGT3X-BT) worn on the right hip for 7 days and for at least 10 hours/day. | Measured at 3 months from baseline | 
| Facets of Mindfulness | Participants will complete the Five Facet Mindfulness Questionnaire. A subscale comprised of 3-facets (observe, act with awareness, and nonreact) will be utilized to measure mindfulness in ELM. The proportion of participants who improve in a 3-facet mindfulness score of greater than or equal to 1 standard deviation of baseline distribution will be calculated. The scale range for the 5-facet mindfulness questionnaire is 39-195 with a lower score reflecting less mindfulness. The 3-facet scale range is 23-115 with a lower score reflecting less mindfulness. | Measuring change from baseline mindfulness at 3 months | 
| Habit formation | The proportion of participants who improve in habit strength in 4 domains (diet, physical activity, emotional control, and sensory awareness), defined as a mean of ≥ 4 on the Self-Report Habit Index will be calculated. A 5-point Likert scale will be used with a scale range from 0 to 20. A lower score reflects a weaker habit. | Measured at 3 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle