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

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

11. Current diagnosis of type 1 or type 2 diabetes, on any diabetes medications except
metformin, or has a screening A1c ≥6.5

12. Inpatient treatment for a psychiatric condition within the past 6 months, or currently
receiving treatment for schizophrenia or other serious psychiatric illness

13. Probable major depression, defined as a PHQ-8 score ≥10

14. Pregnant women, planning a pregnancy in the next 2 months, given birth in the last 6
months, or currently breastfeeding

15. ≥ 30 total days of oral corticosteroid use within the last year, history of solid
organ transplant, or history of stem cell transplant

16. Problematic use of alcohol and/or recreational drugs, defined as ASSIST screening
score of ≥27.

17. Self-reported or known history of an eating disorder (e.g., binging and purging) in
the past 5 years

18. 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

19. History of bowel resection surgery or bariatric surgery

20. Any medical condition known to influence the etiology of MetS as judged by the study
physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc)

21. 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.

22. Cognitive impairment

23. Visual or hearing impairment

24. Currently taking or expecting to take any of the following exclusionary medications:

1. Antiretroviral therapy (e.g., HAART)

2. Weight loss medications (as in #14)

3. Medications known to significantly influence weight or metabolic outcomes

4. Diabetes drugs other than metformin (as in #7)

25. Receiving dialysis

26. Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for
non-melanoma skin cancer